MedTech Archives - Techsol Life Sciences Navigate To Excellence Thu, 13 Jul 2023 07:34:17 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.2 https://www.techsollifesciences.com/wp-content/uploads/2022/12/cropped-techsol-life-sciences-favicon-32x32.png MedTech Archives - Techsol Life Sciences 32 32 Mastering Medical Device Registrations: A Guide to Navigating Regulatory Pathways https://www.techsollifesciences.com/mastering-medical-device-registrations-a-guide-to-navigating-regulatory-pathways/ Wed, 12 Jul 2023 08:07:58 +0000 https://www.techsollifesciences.com/?p=19608 Mastering Medical Device Registrations: A Guide to Navigating Regulatory Pathways As a medical device manufacturer, navigating the complex landscape of regulatory requirements and successfully registering your devices is crucial for market access and commercial success. Medical device registrations play a crucial role in ensuring patient safety, maintaining quality standards, and facilitating market access for medical devices. Manufacturers must prioritize registration to ensure their devices meet regulatory standards, gain market approval, and contribute to improved healthcare outcomes. Following are some of the key drivers for medical device registrations: Regulatory Compliance: Registering medical devices is a regulatory requirement in many jurisdictions. Regulatory authorities, such as the FDA in the United States or the European Medicines Agency (EMA) in the European Union, enforce registration processes to ensure that medical devices meet safety, quality, and performance standards. Compliance with these regulations is essential to avoid penalties, legal consequences, and potential market withdrawal. Patient Safety: Registering medical devices helps ensure patient safety by verifying that the device has undergone appropriate testing, validation, and assessment. Regulatory authorities evaluate device safety and effectiveness to protect patients from potential harm. Registration requires companies to provide evidence of the device’s safety profile, including clinical data, risk assessments, and post-market surveillance plans. Market Access: Device registration is a prerequisite for market access in most countries. Companies must register their devices with the regulatory authority in each targeted market to legally sell and distribute the product. Without proper registration, companies cannot enter new markets, reach patients in need, or gain a competitive advantage. Registration provides market authorization, allowing companies to commercially distribute their medical devices. Reimbursement and Insurance Coverage: In many healthcare systems, reimbursement and insurance coverage for medical devices are linked to device registration. Government payers, private insurance companies, and reimbursement agencies often require evidence of device registration to consider coverage and reimbursement decisions. Without registration, patients may face challenges accessing the device or reimbursing the associated costs. Post-Market Surveillance: Device registration facilitates post-market surveillance activities, including adverse event reporting, product recalls, and safety monitoring. Registered devices are tracked and monitored to identify any emerging safety concerns or performance issues. This enables regulatory authorities to take appropriate actions to protect public health and ensure device safety. Global Harmonization and Trade: Medical device registrations support global harmonization efforts, facilitating trade and collaboration among countries. Regulatory agencies align their requirements and standards to ensure consistency, making it easier for manufacturers to navigate multiple markets. Registrations based on international standards help streamline processes and reduce barriers to market entry. Example scenarios which require medical device registrations: A company developing an innovative implantable cardiac device must register the device to comply with regulatory requirements, demonstrate its safety and efficacy, and gain market approval from the FDA or other relevant regulatory bodies. A manufacturer of diagnostic imaging equipment needs to register their devices to ensure compliance with safety standards, demonstrate their accuracy and performance, and obtain market access in different countries to expand their customer base. A company developing a new digital health application for remote patient monitoring must register the software as a medical device to comply with regulatory requirements, ensure patient data privacy, and gain credibility among healthcare professionals and potential customers. Categories Clinical Trials Company Updates CTMS Drug Safety Medical Information Medical Writing MedTech Pharmacovigilance Regulatory Affairs Validation & Assurance How can we help you? Contact us by submitting a business inquiry online. We will get back to you very soon.  Send Message How to complete Medical Device Registration with different Regulatory Agencies United States – FDA 510(k) Clearance or Premarket Approval (PMA): Medical device manufacturers targeting the U.S. market need to register their devices with the U.S. Food and Drug Administration (FDA). The registration process includes submitting a 510(k) premarket notification or a Premarket Approval (PMA) application, depending on the device’s risk classification. For example, a manufacturer of a new electrocardiogram (ECG) monitoring device would need to obtain FDA clearance or approval to market their product in the United States. European Union – CE Marking: Medical device manufacturers seeking to market their products in the European Union (EU) must register their devices and obtain CE marking. The CE marking indicates compliance with the EU Medical Devices Regulation (MDR) or In Vitro Diagnostic Medical Devices Regulation (IVDR). For instance, a company developing a new implantable orthopedic device would need to register the device and undergo conformity assessment to affix the CE marking for EU market access. Canada – Health Canada Medical Device License: Companies planning to sell medical devices in Canada must register their products with Health Canada and obtain a Medical Device License. The registration process involves submitting a detailed application, including evidence of device safety, effectiveness, and compliance with Canadian regulations. An example would be a manufacturer of a new medical imaging system seeking Health Canada’s approval to market their device in Canada. Japan – Pharmaceutical and Medical Device Agency (PMDA) Approval: Medical device manufacturers targeting the Japanese market must register their devices with the PMDA. The registration process includes the submission of technical documentation, clinical data (if required), and compliance with Japanese regulations. For instance, a company developing a new diagnostic device for detecting infectious diseases would need to obtain PMDA approval for marketing the device in Japan. Australia – Therapeutic Goods Administration (TGA) Conformity Assessment: Companies wishing to sell medical devices in Australia need to register their products with the TGA and undergo a conformity assessment. The assessment verifies that the device meets Australian standards and regulatory requirements. For example, a manufacturer of a new implantable cardiac pacemaker would need to register the device and obtain TGA approval for market access in Australia. India – To initiate medical device registration in India, manufacturers must navigate the registration process overseen by the Central Drugs Standard Control Organization (CDSCO). Manufacturers must stay updated with changing regulations and adapt their strategies accordingly. For example, the recent introduction of the Medical Device Rules 2017 and subsequent amendments brought significant changes to the registration requirements, including the classification system and the introduction

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Mastering Medical Device Registrations: A Guide to Navigating Regulatory Pathways

As a medical device manufacturer, navigating the complex landscape of regulatory requirements and successfully registering your devices is crucial for market access and commercial success. Medical device registrations play a crucial role in ensuring patient safety, maintaining quality standards, and facilitating market access for medical devices. Manufacturers must prioritize registration to ensure their devices meet regulatory standards, gain market approval, and contribute to improved healthcare outcomes. Following are some of the key drivers for medical device registrations:

Regulatory Compliance: Registering medical devices is a regulatory requirement in many jurisdictions. Regulatory authorities, such as the FDA in the United States or the European Medicines Agency (EMA) in the European Union, enforce registration processes to ensure that medical devices meet safety, quality, and performance standards. Compliance with these regulations is essential to avoid penalties, legal consequences, and potential market withdrawal.

Patient Safety: Registering medical devices helps ensure patient safety by verifying that the device has undergone appropriate testing, validation, and assessment. Regulatory authorities evaluate device safety and effectiveness to protect patients from potential harm. Registration requires companies to provide evidence of the device’s safety profile, including clinical data, risk assessments, and post-market surveillance plans.

Market Access: Device registration is a prerequisite for market access in most countries. Companies must register their devices with the regulatory authority in each targeted market to legally sell and distribute the product. Without proper registration, companies cannot enter new markets, reach patients in need, or gain a competitive advantage. Registration provides market authorization, allowing companies to commercially distribute their medical devices.

Reimbursement and Insurance Coverage: In many healthcare systems, reimbursement and insurance coverage for medical devices are linked to device registration. Government payers, private insurance companies, and reimbursement agencies often require evidence of device registration to consider coverage and reimbursement decisions. Without registration, patients may face challenges accessing the device or reimbursing the associated costs.

Post-Market Surveillance: Device registration facilitates post-market surveillance activities, including adverse event reporting, product recalls, and safety monitoring. Registered devices are tracked and monitored to identify any emerging safety concerns or performance issues. This enables regulatory authorities to take appropriate actions to protect public health and ensure device safety.

Global Harmonization and Trade: Medical device registrations support global harmonization efforts, facilitating trade and collaboration among countries. Regulatory agencies align their requirements and standards to ensure consistency, making it easier for manufacturers to navigate multiple markets. Registrations based on international standards help streamline processes and reduce barriers to market entry.

Example scenarios which require medical device registrations:

  • A company developing an innovative implantable cardiac device must register the device to comply with regulatory requirements, demonstrate its safety and efficacy, and gain market approval from the FDA or other relevant regulatory bodies.
  • A manufacturer of diagnostic imaging equipment needs to register their devices to ensure compliance with safety standards, demonstrate their accuracy and performance, and obtain market access in different countries to expand their customer base.
  • A company developing a new digital health application for remote patient monitoring must register the software as a medical device to comply with regulatory requirements, ensure patient data privacy, and gain credibility among healthcare professionals and potential customers.
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How to complete Medical Device Registration with different Regulatory Agencies

United States – FDA 510(k) Clearance or Premarket Approval (PMA): Medical device manufacturers targeting the U.S. market need to register their devices with the U.S. Food and Drug Administration (FDA). The registration process includes submitting a 510(k) premarket notification or a Premarket Approval (PMA) application, depending on the device’s risk classification. For example, a manufacturer of a new electrocardiogram (ECG) monitoring device would need to obtain FDA clearance or approval to market their product in the United States.

European Union – CE Marking: Medical device manufacturers seeking to market their products in the European Union (EU) must register their devices and obtain CE marking. The CE marking indicates compliance with the EU Medical Devices Regulation (MDR) or In Vitro Diagnostic Medical Devices Regulation (IVDR). For instance, a company developing a new implantable orthopedic device would need to register the device and undergo conformity assessment to affix the CE marking for EU market access.

Canada – Health Canada Medical Device License: Companies planning to sell medical devices in Canada must register their products with Health Canada and obtain a Medical Device License. The registration process involves submitting a detailed application, including evidence of device safety, effectiveness, and compliance with Canadian regulations. An example would be a manufacturer of a new medical imaging system seeking Health Canada’s approval to market their device in Canada.

Japan – Pharmaceutical and Medical Device Agency (PMDA) Approval: Medical device manufacturers targeting the Japanese market must register their devices with the PMDA. The registration process includes the submission of technical documentation, clinical data (if required), and compliance with Japanese regulations. For instance, a company developing a new diagnostic device for detecting infectious diseases would need to obtain PMDA approval for marketing the device in Japan.

Australia – Therapeutic Goods Administration (TGA) Conformity Assessment: Companies wishing to sell medical devices in Australia need to register their products with the TGA and undergo a conformity assessment. The assessment verifies that the device meets Australian standards and regulatory requirements. For example, a manufacturer of a new implantable cardiac pacemaker would need to register the device and obtain TGA approval for market access in Australia.

India – To initiate medical device registration in India, manufacturers must navigate the registration process overseen by the Central Drugs Standard Control Organization (CDSCO). Manufacturers must stay updated with changing regulations and adapt their strategies accordingly. For example, the recent introduction of the Medical Device Rules 2017 and subsequent amendments brought significant changes to the registration requirements, including the classification system and the introduction of unique device identification (UDI) for certain device classes.

These examples highlight the need for medical device manufacturers to register their products with different regulatory agencies worldwide. Each jurisdiction has specific regulations and requirements to ensure the safety, effectiveness, and quality of medical devices available to healthcare providers and patients. By registering with the appropriate regulatory agencies, manufacturers can legally market their devices in different markets, gain customer trust, and contribute to patient care.

Overcoming Challenges While Completing Medical Device Registrations

Medical device registrations can present several challenges due to the complex regulatory landscape and varying requirements across different jurisdictions. Here are some common challenges in medical device registrations and practical methods to overcome them:

Regulatory Compliance: Navigating and complying with diverse and evolving regulatory requirements in different regions can be challenging. Stay updated on regulatory changes by actively monitoring updates from regulatory authorities and seeking guidance from regulatory experts. Engage in early communication with regulatory authorities to clarify requirements and seek their input. Establish strong relationships with regulatory consultants or specialized firms to ensure compliance with relevant regulations.

Classification and Risk Assessment: Proper classification and risk assessment of medical devices can be complex, particularly for innovative devices or those without clear predicates. Seek guidance from regulatory experts or consultants who are well-versed in device classification and risk assessment. Conduct thorough research and gather relevant scientific evidence to support the device’s classification and risk profile. Engage in discussions with regulatory authorities to obtain their input and ensure alignment on classification and risk assessment.

Clinical Evidence Requirements: Generating and collecting sufficient clinical evidence to support the safety and efficacy of the device can be time-consuming and resource-intensive. Design and conduct well-planned clinical studies that align with regulatory requirements. Consider leveraging real-world evidence, post-market surveillance data, or data from similar devices to complement clinical data. Collaborate with experienced clinical research organizations (CROs) to optimize study design, patient recruitment, and data collection processes.

Quality Management System (QMS) Compliance: Establishing and maintaining a robust QMS that meets regulatory expectations can be challenging, especially for smaller companies with limited resources. Implement a comprehensive QMS that aligns with internationally recognized standards such as ISO 13485. Engage with quality experts or consultants to develop and implement an efficient QMS. Conduct regular internal audits and invest in staff training to ensure ongoing compliance with QMS requirements.

Timelines and Time-to-Market: The registration process can be time-consuming, potentially delaying market entry and time-to-market. Develop a detailed project plan that includes realistic timelines for each stage of the registration process. Anticipate potential delays and build buffers into the timeline. Proactively communicate with regulatory authorities, leveraging pre-submission meetings or expedited review programs, where available, to expedite the process. Consider leveraging regulatory expedited pathways, such as the FDA’s Breakthrough Device Designation or the EU’s Priority Review, when applicable.

Local Representation and Language Barriers: Some jurisdictions require local representation or authorized agents, which can pose challenges in identifying suitable partners with regulatory knowledge and language proficiency. Seek guidance from regulatory consultants or legal advisors familiar with the target region to identify reputable local representatives or distributors. Evaluate their experience, capabilities, and language proficiency to ensure effective communication and collaboration.

These methods provide practical approaches to overcoming challenges in medical device registrations. However, it’s important to tailor strategies to the specific context and seek guidance from regulatory experts who can provide customized solutions based on the device, target markets, and regulatory landscape. By proactively addressing challenges and leveraging expert support, companies can navigate the registration process more efficiently and ensure compliance with regulatory requirements.

How We Can Help

Are you a medical device manufacturer seeking seamless market access and regulatory compliance for your innovative products? At Techsol, our Medical Device Registration Services are designed to accelerate your path to global markets while ensuring compliance with regulatory requirements. Our team of regulatory experts combines deep industry knowledge with a proven track record of successful registrations worldwide. We offer comprehensive solutions tailored to your unique needs, simplifying the registration process and saving you valuable time and resources.

Contact us today to embark on a seamless journey toward global market access!

 

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]]> Navigating Through EU MDR and IVDR Medical Device Labelling Requirements https://www.techsollifesciences.com/navigating-through-eu-mdr-and-ivdr-medical-device-labelling-requirements/ Mon, 24 Apr 2023 07:47:13 +0000 https://www.techsollifesciences.com/?p=18974 Navigating Through EU MDR and IVDR Medical Device Labelling Requirements The new European Union (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) bring significant changes to the way medical devices are regulated in the EU. One of the most significant changes is the requirement for medical device manufacturers to make labeling changes to comply with the new regulations. In this blog, we will discuss all the labeling changes that must be made as per the new EU MDR and IVDR regulations, the new symbols that must be used, the timelines for implementation, the challenges faced by medical device manufacturers to implement these changes, and the best practices and methods recommended by industry experts. Manufacturers are now required to provide more detailed and accurate information on device labeling, including the device’s intended use, instructions for use, and precautions for use. Additionally, the labeling must be provided in a clear and understandable manner for the user. These changes have led to updates to the EN 1041 and ISO 15223-1 standards, which provide guidance on the information to be supplied by the manufacturer and the symbols to be used with medical device labels.  EN 1041 now mandates that the labeling of medical devices must be in the official language(s) of the country where the device is marketed, as well as in English. This is to ensure that users can understand the labeling regardless of their language proficiency, and aligns with the language requirements introduced by the EU MDR and IVDR.  ISO 15223-1 now includes requirements for ensuring that the labeling of medical devices is accessible to all users, including those with disabilities. This includes using clear and legible fonts, providing information in alternative formats such as braille or audio, and ensuring that color contrast is sufficient for users with visual impairments. Categories Clinical Trials Company Updates CTMS Drug Safety Medical Information Medical Writing MedTech Pharmacovigilance Regulatory Affairs Validation & Assurance How can we help you? Contact us by submitting a business inquiry online. We will get back to you very soon.  Send Message Labeling Requirements by EU MDR and IVDR The Medical Devices Regulation (MDR) (EU) 2017/745 sets out the requirements for the labeling of medical devices placed on the European Union market. The following are some of the key requirements for labeling medical devices under the MDR: MDR Article Device Classification Labeling Requirements Article 10 All Classes Device identification (name, model, type, serial number), manufacturer information (name, registered trade name, address, contact information), UDI (Unique Device Identifier) in both machine-readable and human-readable format, intended use and any limitations or contraindications, symbols and markings compliant with ISO 15223-1, instructions for use (including warnings and precautions), language requirement (official language(s) of the country where the device is placed on the market), shelf-life and storage instructions (if applicable), clinical evaluation indication and reference to relevant documentation Article 17 Implantable Medical Devices Statement that the device is intended for implantation, specific warnings related to implantation Article 21 Devices Containing Human Blood Derivatives Statement that the device contains human blood derivatives, appropriate warnings, precautions, and contraindications related to human blood derivatives Article 22 Devices Incorporating Medicinal Products Statement that the device incorporates a medicinal product, appropriate warnings, precautions, and contraindications related to the medicinal product Article 23 Devices Containing Nanomaterials Statement that the device contains nanomaterials, appropriate information on the risks and benefits associated with the use of nanomaterials Article 27 Class III Medical Devices Information on the clinical investigation, clinical performance, and clinical evaluation of the device, identification of the notified body (if applicable) Article 29 Active Implantable Medical Devices Specific labeling requirements related to the programmable parameters of the device Article 31 In Vitro Diagnostic Medical Devices Appropriate labeling for the intended purpose and clinical use of the device, instructions for use, limitations of the device, performance characteristics, reference to the relevant common technical specification Annex XIII Class III and Active Implantable Medical Devices Specific labeling requirements related to the unique device identification (UDI) New Symbols Required by EU MDR and IVDR The new EU MDR and IVDR introduce several new symbols that medical device manufacturers must use on their products to comply with the regulations. These symbols include: Useful Resources Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices Use of Symbols to Indicate Compliance with the MDR – MedTech Europe  MDR labelling requirements – medical device regulation – A comprehensive Guide (Prepared by BSI Group) EUDAMED User Guide for UDI Devices  EU UDI Helpdesk Videos  Timelines for Implementation The timelines for the implementation of new symbols required by the European Medical Devices Regulation (MDR) (EU) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746 vary depending on the article and classification of the medical device. Here’s a brief summary of the timelines: Date Event May 25, 2017 MDR (EU) 2017/745 Regulation published May 26, 2020 MDR (EU) 2017/745 Regulation enforcement date May 26, 2022 IVDR (EU) 2017/746 Regulation enforcement date May 26, 2022 Implementation of Unique Device Identification (UDI) system May 26, 2022 Implementation of new symbols required by MDR (EU) 2017/745 May 26, 2024 Deadline for all medical devices to comply with MDR (EU) 2017/745 May 26, 2025 Deadline for all in vitro diagnostic medical devices to comply with IVDR (EU) 2017/746 May 26, 2025 Implementation of new symbols required by IVDR (EU) 2017/746 May 26, 2026 Deadline for all legacy devices to comply with MDR (EU) 2017/745 May 26, 2030 Deadline for all legacy in vitro diagnostic medical devices to comply with IVDR (EU) 2017/746 It’s important to note that these timelines are subject to change, and manufacturers should always refer to the latest guidance and regulatory updates to ensure compliance with the most up-to-date requirements. Additionally, the European Commission has indicated that it may develop additional symbols in the future to address emerging safety concerns or other issues, so manufacturers should stay informed of any developments in this area. Challenges Faced by Manufacturers Implementing the

The post Navigating Through EU MDR and IVDR Medical Device Labelling Requirements appeared first on Techsol Life Sciences.

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Navigating Through EU MDR and IVDR Medical Device Labelling Requirements

The new European Union (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) bring significant changes to the way medical devices are regulated in the EU. One of the most significant changes is the requirement for medical device manufacturers to make labeling changes to comply with the new regulations. In this blog, we will discuss all the labeling changes that must be made as per the new EU MDR and IVDR regulations, the new symbols that must be used, the timelines for implementation, the challenges faced by medical device manufacturers to implement these changes, and the best practices and methods recommended by industry experts.

Medical Device label - Techsol Life Sciences

Manufacturers are now required to provide more detailed and accurate information on device labeling, including the device’s intended use, instructions for use, and precautions for use. Additionally, the labeling must be provided in a clear and understandable manner for the user.

These changes have led to updates to the EN 1041 and ISO 15223-1 standards, which provide guidance on the information to be supplied by the manufacturer and the symbols to be used with medical device labels. 

EN 1041 now mandates that the labeling of medical devices must be in the official language(s) of the country where the device is marketed, as well as in English. This is to ensure that users can understand the labeling regardless of their language proficiency, and aligns with the language requirements introduced by the EU MDR and IVDR. 

ISO 15223-1 now includes requirements for ensuring that the labeling of medical devices is accessible to all users, including those with disabilities. This includes using clear and legible fonts, providing information in alternative formats such as braille or audio, and ensuring that color contrast is sufficient for users with visual impairments.

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Labeling Requirements by EU MDR and IVDR

The Medical Devices Regulation (MDR) (EU) 2017/745 sets out the requirements for the labeling of medical devices placed on the European Union market. The following are some of the key requirements for labeling medical devices under the MDR:

MDR Article

Device Classification

Labeling Requirements

Article 10

All Classes

Device identification (name, model, type, serial number), manufacturer information (name, registered trade name, address, contact information), UDI (Unique Device Identifier) in both machine-readable and human-readable format, intended use and any limitations or contraindications, symbols and markings compliant with ISO 15223-1, instructions for use (including warnings and precautions), language requirement (official language(s) of the country where the device is placed on the market), shelf-life and storage instructions (if applicable), clinical evaluation indication and reference to relevant documentation

Article 17

Implantable Medical Devices

Statement that the device is intended for implantation, specific warnings related to implantation

Article 21

Devices Containing Human Blood Derivatives

Statement that the device contains human blood derivatives, appropriate warnings, precautions, and contraindications related to human blood derivatives

Article 22

Devices Incorporating Medicinal Products

Statement that the device incorporates a medicinal product, appropriate warnings, precautions, and contraindications related to the medicinal product

Article 23

Devices Containing Nanomaterials

Statement that the device contains nanomaterials, appropriate information on the risks and benefits associated with the use of nanomaterials

Article 27

Class III Medical Devices

Information on the clinical investigation, clinical performance, and clinical evaluation of the device, identification of the notified body (if applicable)

Article 29

Active Implantable Medical Devices

Specific labeling requirements related to the programmable parameters of the device

Article 31

In Vitro Diagnostic Medical Devices

Appropriate labeling for the intended purpose and clinical use of the device, instructions for use, limitations of the device, performance characteristics, reference to the relevant common technical specification

Annex XIII

Class III and Active Implantable Medical Devices

Specific labeling requirements related to the unique device identification (UDI)

New Symbols Required by EU MDR and IVDR

The new EU MDR and IVDR introduce several new symbols that medical device manufacturers must use on their products to comply with the regulations. These symbols include:

Symbol Description
CE marking Indicates that the device meets the requirements of the MDR
Unique Device Identification (UDI) A system for identifying and tracing medical devices throughout their lifecycle
Lot number Identifies the production lot from which the device came
Serial number Identifies the individual device within the production lot
Batch code A code that identifies the production batch
Catalogue number The number used to identify the device in the manufacturer's catalogue
Date of manufacture The date on which the device was manufactured
Manufacturer The name or trade name of the manufacturer
Authorized representative in the EU The name or trade name of the authorized representative in the EU
Do not reuse Indicates that the device is intended for single-use only and should not be reused
Minimum temperature for use The minimum temperature at which the device can be used safely
Maximum temperature for use The maximum temperature at which the device can be used safely
Sterilized using irradiation Indicates that the device has been sterilized using irradiation
Sterilized using ethylene oxide Indicates that the device has been sterilized using ethylene oxide
Sterilized using steam Indicates that the device has been sterilized using steam
Sterilized using dry heat Indicates that the device has been sterilized using dry heat
Sterilized using moist heat Indicates that the device has been sterilized using moist heat
Sterilized using gas plasma Indicates that the device has been sterilized using gas plasma
Sterilized using aseptic processing Indicates that the device has been sterilized using aseptic processing
Sterilized using other methods Indicates that the device has been sterilized using other methods
Single-use device Indicates that the device is intended for single-use only
Use by date The date by which the device should be used
Caution, consult accompanying documents Indicates that the device comes with accompanying documents that should be consulted
Protect from moisture Indicates that the device should be protected from moisture
For in vitro diagnostic use only Indicates that the device is intended for in vitro diagnostic use only
Do not use if package is damaged Indicates that the device should not be used if the package is damaged
Medical device, do not reuse Indicates that the device is a medical device intended for single-use only
Sterilization load number A unique identifier for each load of devices that are sterilized together

Useful Resources

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices

Use of Symbols to Indicate Compliance with the MDR – MedTech Europe 

MDR labelling requirements – medical device regulation – A comprehensive Guide (Prepared by BSI Group)

EUDAMED User Guide for UDI Devices 

EU UDI Helpdesk Videos 

Timelines for Implementation

The timelines for the implementation of new symbols required by the European Medical Devices Regulation (MDR) (EU) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746 vary depending on the article and classification of the medical device. Here’s a brief summary of the timelines:

Date

Event

May 25, 2017

MDR (EU) 2017/745 Regulation published

May 26, 2020

MDR (EU) 2017/745 Regulation enforcement date

May 26, 2022

IVDR (EU) 2017/746 Regulation enforcement date

May 26, 2022

Implementation of Unique Device Identification (UDI) system

May 26, 2022

Implementation of new symbols required by MDR (EU) 2017/745

May 26, 2024

Deadline for all medical devices to comply with MDR (EU) 2017/745

May 26, 2025

Deadline for all in vitro diagnostic medical devices to comply with IVDR (EU) 2017/746

May 26, 2025

Implementation of new symbols required by IVDR (EU) 2017/746

May 26, 2026

Deadline for all legacy devices to comply with MDR (EU) 2017/745

May 26, 2030

Deadline for all legacy in vitro diagnostic medical devices to comply with IVDR (EU) 2017/746

It’s important to note that these timelines are subject to change, and manufacturers should always refer to the latest guidance and regulatory updates to ensure compliance with the most up-to-date requirements. Additionally, the European Commission has indicated that it may develop additional symbols in the future to address emerging safety concerns or other issues, so manufacturers should stay informed of any developments in this area.

Challenges Faced by Manufacturers

Implementing the labeling changes as per the EU MDR and IVDR can pose challenges for medical device manufacturers. Some of the key challenges include:

>  Time and resources: Updating labeling to comply with the new regulations can be time-consuming and resource-intensive, particularly for companies with a large number of products on the market.

>  Increased complexity: The new regulations require more detailed and specific labeling information, including new symbols and UDI requirements. This can make labeling more complex, and can increase the risk of errors or inconsistencies.

>  Translation requirements: The regulations require that labeling information be provided in all official languages of the EU countries where the product will be sold. This can be particularly challenging for manufacturers with a global market presence.

>  Product redesign: In some cases, complying with the new labeling requirements may require changes to the product design or packaging.

>  Lack of guidance: The EU MDR and IVDR regulations are complex and comprehensive, and there may be a lack of clear guidance from regulatory bodies on how to comply with the new labeling requirements.

>  Impact on supply chain: Changes to labeling requirements may also affect the supply chain, as manufacturers may need to work with suppliers to ensure that labeling information is provided in the correct format and meets the new requirements.

Best Practices, Methods, and Labeling Change Implementation Strategies

Meeting labeling requirements Required by EU MDR and IVDR by MDR Articles according to the MDR (EU) 2017/745 Regulation can be challenging, but there are several best practices that can help you ensure compliance. Here are some of the best practices:

  1. Stay up to date with the latest regulations and guidance: The MDR (EU) 2017/745 Regulation is a complex set of regulations, and it’s important to stay up to date with the latest updates and guidance. This will help you ensure that your labeling is in compliance with the latest requirements. 

  2. Develop a labeling strategy: Developing a labeling strategy can help you ensure that all of your labeling requirements are met. This should include a plan for how you will handle translations, symbols, and the UDI system. Perform a risk assessment to identify potential risks associated with the device’s labeling, such as incorrect or unclear information. The risk assessment must also include a plan to mitigate those risks.

  3. Conduct a labeling assessment: Conducting a labeling assessment can help you identify any gaps in your labeling processes and ensure that all of your labeling requirements are being met. This can include an evaluation of your labeling processes, label content, label format, label placement, and translation.

  4. Use a labeling software solution: Using a labeling software solution can help you ensure that all of your labeling requirements are met, including translations, symbols, and the UDI system. It can also help you streamline your labeling processes and reduce the risk of errors. The labeling content must be clear, concise, and easy to understand for the intended user. The labeling must also include the essential information for the device, such as its intended use, instructions for use, and precautions.

  5. Partner with a labeling expert: Partnering with a labeling expert can help you ensure that your labeling requirements are met and that you stay up to date with the latest regulations and guidance. This can include consulting services, label design and development, and label translation services.

  6. Test your labeling: Testing your labeling can help you ensure that it is clear, readable, and meets all of the regulatory requirements. This can include readability testing, validation testing, and verification testing. 

Importantly, communicate the labeling change to all relevant stakeholders, including customers, distributors, and regulatory authorities. By following these best practices, you can ensure that your labeling is in compliance with the latest EU MDR and IVDR requirements and that you are able to meet the needs of your customers and stakeholders.

References:

    1. European Commission. Medical Devices. https://ec.europa.eu/growth/sectors/medical-devices_en
    2. European Parliament and Council. Regulation (EU) 2017/745 on medical devices. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745
    3. European Parliament and Council. Regulation (EU) 2017/746 on in vitro diagnostic medical devices. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0746
    4. KPMG. “Labeling requirements for medical devices under the new EU MDR and IVDR.” https://advisory.kpmg.us/articles/2020/labeling-requirements-medical-devices-eu-mdr-ivdr.html

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]]> Top 4 Trial Design Best Practices for Medical Device Clinical Studies https://www.techsollifesciences.com/top-4-trial-design-best-practices-for-medical-device-clinical-studies/ Mon, 18 Oct 2021 10:17:00 +0000 https://www.techsollifesciences.com/?p=9481 October 18, 2021 Posted by: admin Category: MedTech No Comments What drives the growing complexity in medical device clinical trials? The medical devices industry has revolutionized medicine with significant advances in both detection and treatment of diseases. Clinical trials for medical device regulatory approval are designed to produce valid scientific evidence of safety and effectiveness for the intended uses. Moreover, sponsors must consider designing trials to demonstrate evidence required for payers, clinicians, and other important stakeholders. Typically, a core data set for a trial includes endpoints and data supporting regulatory approval, reimbursement, and other critical objectives. There are rigorous regulations formulated by the U.S. Food and Drug Administration (FDA) and EU’s Medical Device (MDR) for class IIb and class III medical devices (i.e. medium and high-risk medical devices such as implantable medical devices or in vitro diagnostic devices- IVDR) [1] Regulators and payers are demanding more clinical evidence by device manufacturers to reflect the benefit-risk profile of the device. They need more crucial clinical evaluation before market approval and to substantiate product value claims. Clinical evidence of medical devices is critical not only for displaying the safety and efficacy of the device but also for notifying clinicians and patients about the ideal use of the device in the marketed clinical setting. This appeal for clinical evidence from various stakeholders is forcing medical device companies and sponsors to amass more “defensive clinical data” on their products than ever before. Companies are responding to this pressure by conducting extensive clinical trials, focus group studies, and responding in real-time by making changes to the software applications of their medical devices. Here are 4 essential best practices for conducting clinical trials on medical devices. Categories Clinical Trials Company Updates CTMS Drug Safety Medical Information MedTech Pharmacovigilance Regulatory Affairs Validation & Assurance How can we help you? Contact us by submitting a business inquiry online. We will get back to you very soon.  Send Message 1. Blinding – MedTech Clinical Trials Bias And How To Avoid Them Blinding is an essential part of a clinical trial as it diminishes measurement bias associated with the observer’s, doctor’s, or patient’s preconception. For ethical reasons, blinding is difficult to perform in randomized clinical trials of medical devices compared to therapeutic randomized clinical trials. Despite the practical difficulties with therapeutic procedures, some trials have been successfully conducted with complete blinding, involving an identical placebo. Blinding is complete when the interference is simulated in the control group with no contact between the surgeon and the team responsible for the patient’s follow-up. Medical device companies need to ensure that when blinding is not workable, a blind assessment of the outcome should be planned with experienced staff as outcome assessors. They must also provide appropriate reasons for not blinding and discuss the limitations when reporting the results. In recent times, regulatory agencies have highlighted the use of creative methods to blind individuals in the trials. Any novel blinding technique must ensure that it should have 3 basic qualities: Effective concealing of the group allocation No disruption in the ability to accurately assess outcomes Approval by the individuals that will be assessing outcomes Regardless of careful contemplation of methods to blind individuals in medical device clinical trials, conditions will invariably arise when a certain group of individuals cannot ethically be blinded. MedTech companies can incorporate other alternative strategies to minimize bias when blinding is not possible such as “partial blinding”. This involves partial information being given to the participants, who may not be informed of standard treatment, e.g. the hypothesis that one treatment is superior to other, or of the randomization outcome for patients under a modified trial design. In these situations, patients must be advised on scientific grounds that, they will not be informed of the study’s specific objective but will have access to all the information at the end of the study. 2. Sample Size Calculation Errors and How to Avoid It Designing and organizing a clinical trial for a medical device is risky and expensive and to avoid the depletion of resources and time, it is essential to get the design right. The sample size is a critical component of any clinical trial. A trial with a small research group is more prone to inconsistency and carries a substantial risk of failing to demonstrate the effectiveness of a given intervention. There are specific recurrent errors that have been observed in trial records and protocols which can seriously compromise the scientific validity of the trial and therefore the regulatory approval. Figure 1. Common errors in sample size calculation Incorrect sample size calculations The sample size is influenced by the interaction of prior knowledge of the device with the objective and number of subjects available. Generally, the more subjects, the more reliable the reported result will be; but at the same time more subjects equal more cost. The sample size helps in prospectively estimating the number of subjects needed to provide the desired result. However, estimating sample size is complex as there is very limited data available about how the device will perform. If the trial gives erroneous results, any claim made has no validity and consequently leads to wastage of time and money. Using Interim analysis without considering the sample size An interim analysis is helpful to identify if the trial can be stopped early by establishing that the primary endpoint has been achieved. This analysis to check for an early stop increases the sample size required for the study. Hence it is recommended to plan and document before the study starts, to avoid the risk of increasing the chance of a false positive study conclusion. Such conclusions could be scrutinized by regulators and are likely to result in rejection of the trial result. Collecting too much (or too little) data Data collection and analysis is an expensive process and so it is important to consider what data is needed and its uses. Too much data can lead to difficulty in analyzing and compromises the quality of the important data,

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  • October 18, 2021
  • Posted by: Techsol Life Sciences
  • Category: MedTech
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Medical Device Clinical Trials | Techsol Life Sciences

What drives the growing complexity in medical device clinical trials?

The medical devices industry has revolutionized medicine with significant advances in both detection and treatment of diseases. Clinical trials for medical device regulatory approval are designed to produce valid scientific evidence of safety and effectiveness for the intended uses. Moreover, sponsors must consider designing trials to demonstrate evidence required for payers, clinicians, and other important stakeholders. Typically, a core data set for a trial includes endpoints and data supporting regulatory approval, reimbursement, and other critical objectives.

There are rigorous regulations formulated by the U.S. Food and Drug Administration (FDA) and EU’s Medical Device (MDR) for class IIb and class III medical devices (i.e. medium and high-risk medical devices such as implantable medical devices or in vitro diagnostic devices- IVDR) [1] Regulators and payers are demanding more clinical evidence by device manufacturers to reflect the benefit-risk profile of the device. They need more crucial clinical evaluation before market approval and to substantiate product value claims. Clinical evidence of medical devices is critical not only for displaying the safety and efficacy of the device but also for notifying clinicians and patients about the ideal use of the device in the marketed clinical setting. This appeal for clinical evidence from various stakeholders is forcing medical device companies and sponsors to amass more “defensive clinical data” on their products than ever before. Companies are responding to this pressure by conducting extensive clinical trials, focus group studies, and responding in real-time by making changes to the software applications of their medical devices.

Here are 4 essential best practices for conducting clinical trials on medical devices.

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1. Blinding – MedTech Clinical Trials Bias And How To Avoid Them

Blinding is an essential part of a clinical trial as it diminishes measurement bias associated with the observer’s, doctor’s, or patient’s preconception. For ethical reasons, blinding is difficult to perform in randomized clinical trials of medical devices compared to therapeutic randomized clinical trials. Despite the practical difficulties with therapeutic procedures, some trials have been successfully conducted with complete blinding, involving an identical placebo. Blinding is complete when the interference is simulated in the control group with no contact between the surgeon and the team responsible for the patient’s follow-up.

Medical device companies need to ensure that when blinding is not workable, a blind assessment of the outcome should be planned with experienced staff as outcome assessors. They must also provide appropriate reasons for not blinding and discuss the limitations when reporting the results. In recent times, regulatory agencies have highlighted the use of creative methods to blind individuals in the trials.

Any novel blinding technique must ensure that it should have 3 basic qualities:

  • Effective concealing of the group allocation
  • No disruption in the ability to accurately assess outcomes
  • Approval by the individuals that will be assessing outcomes

Regardless of careful contemplation of methods to blind individuals in medical device clinical trials, conditions will invariably arise when a certain group of individuals cannot ethically be blinded. MedTech companies can incorporate other alternative strategies to minimize bias when blinding is not possible such as “partial blinding”. This involves partial information being given to the participants, who may not be informed of standard treatment, e.g. the hypothesis that one treatment is superior to other, or of the randomization outcome for patients under a modified trial design. In these situations, patients must be advised on scientific grounds that, they will not be informed of the study’s specific objective but will have access to all the information at the end of the study.

Medical Device Clinical Trial Characterestics

2. Sample Size Calculation Errors and How to Avoid It

Designing and organizing a clinical trial for a medical device is risky and expensive and to avoid the depletion of resources and time, it is essential to get the design right. The sample size is a critical component of any clinical trial. A trial with a small research group is more prone to inconsistency and carries a substantial risk of failing to demonstrate the effectiveness of a given intervention. There are specific recurrent errors that have been observed in trial records and protocols which can seriously compromise the scientific validity of the trial and therefore the regulatory approval.

Medical Device Clinical Trial Errors

Figure 1. Common errors in sample size calculation

  • Incorrect sample size calculations

The sample size is influenced by the interaction of prior knowledge of the device with the objective and number of subjects available. Generally, the more subjects, the more reliable the reported result will be; but at the same time more subjects equal more cost.

The sample size helps in prospectively estimating the number of subjects needed to provide the desired result. However, estimating sample size is complex as there is very limited data available about how the device will perform. If the trial gives erroneous results, any claim made has no validity and consequently leads to wastage of time and money.

  • Using Interim analysis without considering the sample size

An interim analysis is helpful to identify if the trial can be stopped early by establishing that the primary endpoint has been achieved. This analysis to check for an early stop increases the sample size required for the study. Hence it is recommended to plan and document before the study starts, to avoid the risk of increasing the chance of a false positive study conclusion. Such conclusions could be scrutinized by regulators and are likely to result in rejection of the trial result.

  • Collecting too much (or too little) data

Data collection and analysis is an expensive process and so it is important to consider what data is needed and its uses. Too much data can lead to difficulty in analyzing and compromises the quality of the important data, however, too little can compromise the entire study itself.

Example:

For example, changes in medication use can be recorded but is very hard to relate to an outcome, e.g. does 20mg paracetamol provide more or less pain relief than 60mg ibuprofen with a non-steroidal?

  • Including too many analyses

Organizing too many analyses could lead to ambiguous and incorrect inferences. Secondary endpoints and subgroup analyses can quickly mount up unless there is a clear focus on what is being deduced.

3. Selecting the Right Primary and Secondary End Points

An endpoint is a single trial outcome value that is measured for each subject. To address the trial objective, the individual subject endpoint data must be summarised. This may be a simple or more complex statistical process. [2]

Thus, inadequately defining the endpoint may result in failing to address the objective, and therefore falls short to satisfy the regulators.

Primary Endpoint

The trial design should evaluate the safety and effectiveness of the device in a given population under study. In general, it is divided into one or more primary “safety” and “effectiveness” endpoints. A study would be considered successful if both the safety and effectiveness endpoints are met [3].

The clinical trial protocol should evidently and prospectively detail

  • Comprehensive methods for obtaining endpoint data
  • Descriptions for what will be counted as a primary event in the analysis
  • Circumstances in which patient data will be excluded
  • How missing data will be handled
  • How the impact of covariates will be assessed[3]

To determine the primary endpoint a minimum number of patients and duration of follow-up may be required depending on understanding the safety and effectiveness of the device.

Secondary Endpoints

Secondary endpoints are used to evaluate additional claims where they provide further insights into the device’s effects and mechanisms of action. Submission Elements, Pivotal Investigational device exemption (IDEs), feasibility study provide enough detail to avoid ambiguity once the trial has started. Secondary endpoints are mostly used to support claims if the primary endpoints are successful.

4. Choosing Right Exploratory and Inferential Statistical Methods for MedTech clinical trials

Statistical Approaches to Analysis of Clinical Trials

An indispensable element to a well-designed clinical trial is its appropriate statistical analysis. Presuming that a clinical trial will provide data that could reveal differences between two or more mediations, statistical analyses are used to determine whether such differences are real or are due to chance. Data analysis for clinical trials is important to make a clear distinction between preliminary evidence and confirmatory analysis. When the sample population size is small, it is essential to gather considerable preliminary evidence on related subjects before the trial is conducted to define the size needed to determine a critical effect. For example, a trial with eight participants may have adequate statistical power, expressing the probability of rejecting the null hypothesis when the hypothesis is false.

Thus, testing a null hypothesis could be challenging for a small clinical trial framework. It is therefore important to focus on evidence rather than to test a hypothesis. This is because a small clinical trial is less likely to be self-contained, providing all of the necessary indications to effectively test a particular hypothesis. A single large clinical trial is often inadequate to answer a biomedical research question, and it is even more unlikely that a single small clinical trial can do so. Thus, analyses of data must consider the limitations of the data at hand and their background in contrast with those of other related studies [4].

Since data analysis for small clinical trials unavoidably involves a number of assumptions, it is reasonable that several different statistical analyses be conducted. If these analyses give consistent results under different assumptions, one can be assured that the results are not due to unwarranted expectations [4].

References:

1. Joshi, S. (2020, June 1). Clinical Trials for Medical Devices: 5 Expert Tips. The Kolabtree Blog. https://www.kolabtree.com/blog/clinical-trials-for-medical-devices-5-expert-tips/
2. Yellowlees, I. (2021, June 12). Sample Size and Other Common Medical Device Trial Design Errors that Matter. Quantics Biostatistics. https://www.quantics.co.uk/blog/6-common-medical-device-trial-design-errors-that-matter/
3. [Image].Https://Www.Slideshare.Net/Medicres/Fda-2013-Clinical-Investigator-Training-Course-Issues-in-Clinical-Trials-Designs-for-Devices
4. NCBI Bookshelf. (2001). Retrieved 2021, from https://www.ncbi.nlm.nih.gov/books/NBK223333/

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]]> Combination Products Reporting – Pharma & Medical Devices liaise with NCA https://www.techsollifesciences.com/combination-products-reporting-how-pharma-medical-devices-liaise-with-national-competent-authorities/ Wed, 03 Mar 2021 12:43:00 +0000 https://www.techsollifesciences.com/?p=9364 March 3, 2021 Posted by: admin Category: MedTech No Comments Today, more and more combination products are being developed to address the ever-increasing demands of patients who require more advanced and more effective treatments. Earlier, traditional pharmaceuticals, medical devices, and biologics were the only options for treating the various medical conditions that people experienced. However, the steep rise in aging populations, has caused a shift in the healthcare industry. This shift is toward manufacturing products that can deliver more than what the traditional treatments currently provide. Combination products are one type of treatment option that can meet the more rigorous demands of today’s patients. Definition of a Combination Product Combination products are usually therapeutic and diagnostic products that combine drugs, devices or biological products. They consist of two or more regulated components. Each drug, device, and biological product included in a combination product is referred to as a constituent part of the combination product. They can include several combinations such as: Drug/device Biologic/device Drug/biologic Drug/device/biologic Categories Clinical Trials Company Updates CTMS Drug Safety Medical Information MedTech Pharmacovigilance Regulatory Affairs Validation & Assurance How can we help you? Contact us by submitting a business inquiry online. We will get back to you very soon.  Send Message Examples of Combination Products are metered-dose inhalers co-packaged with a filled drug product cartridge, vaccines supplied as a pre-filled syringe and drug-eluting stents. The Growing Demand for Combination Products Patients are demanding more innovative drugs which can help cure their ailments. Modern day patients are insisting on speedy delivery of therapeutics, ease of use and affordability. These demands made the drug companies to focus on the invention and production of Combination Products. Combination Products are now integral to the drug manufacturing industry. According to the Globe Newswire Global Forecast, the Drug Device Combination Product market is expected to reach 177.7 billion USD by 2024. Given this forecast, the manufacturing companies have a responsibility to safely meet patients’ expectations, continuously improve and monitor the production and use of these products. Safety Reporting for Combination Products As the demand for combination products increases and more products are introduced into the market, it has become a growing concern for National Competent Authorities (NCAs) and Pharma companies to report and track device malfunction adverse events. There are several cases where the FDA has issued many warning letters to pharmaceutical and device manufacturing companies to maintain safety and quality in their systems. For instance: Recently, the cardiac implants of a Medical Device giant received alerts from FDA about two dangerous security flaws affecting a number of implantable devices. Such instances are a Heads Up for Global Drug Safety Departments to: Take up extensive safety processing for combination products to ensure effective compliance. Create separate departments logging quality complaints and performing initial and final review Monitor recordkeeping requirements that enable safety data archiving Conduct continuous research and progressive development to fulfill patient needs In today’s highly competitive and informative scenario, there is a strong focus on Postmarketing Safety Reporting (PMSR) requirements for Combination Products. Increased efforts have been made to understand the evolving global regulations and to determine the best compliance strategies. Reporting and Tracking of Adverse Events Marketing and Regulatory Requirements for Combination Products Based on the type of scenario or event received, drug companies have to submit different reports to Notified bodies. Some of the prominent reports are 15 day reports, malfunction reports, 5 day reports, periodic reports, field alert reports and biological product deviation reports (BPDRs). Companies also need to submit several applications to the relevant agencies before they can market their combination products. The Marketing Applications required for Combination Products are: NDA – Report to CDER BLA – Report to CBER PMAs- To legally sell CLASS III PDPs HDEs De Novo Classification Requests (De Novos) 510(k)s – To legally sell CLASS II Assigning Combination Products for Review A Combination Product is assigned to a particular FDA lead center that has primary jurisdiction for its premarket review and regulation. The Primary Mode of Action (PMOA) of a combination product is determined before its assignment to a FDA center as required under section 503(g)(1) of the FD&C Act. Section 503(g) defines the PMOA as ‘the single mode of action of a combination product that provides the most important therapeutic action of the combination product’. Even after a combination product is assigned to a lead center, all applicable centers coordinate with each other and the Office of Combination Products for post market safety reporting if the need arises. General Considerations for Combination Product PMSR Compliance FDA issued the final rule on postmarketing safety reporting (PMSR) requirements for combination products on December 20, 2016 (81 FR 92603). The rule, as codified in 21 CFR 4, Subpart B, describes the method of compliance with PMSR requirements for combination products that have received FDA marketing authorization. The final rule addresses combination products that are subject to premarket review by FDA. The entities subject to the final rule are ‘Combination Product Applicants’ and ‘Constituent Part Applicants’ The most important aspects of the final rule are: Application Type-Based Reporting Requirements: These requirements apply to both Combination Product Applicants and Constituent Part Applicants, based on the application type under which the combination product or constituent part has received marketing authorization. Constituent Part-Based Reporting Requirements: These requirements apply only to Combination Product Applicants and are based on the types of constituent parts included in the combination product. Information Sharing. Constituent Part Applicants have to share certain postmarketing safety information which they receive with each other. Submission Process: The final rule specifies the exact process of submitting Combination Product and Constituent Part Applicants PMSR information to the Agency. Streamlined reporting: The rule specifies certain ways to meet specific reporting requirements together in the same report. Records Retention: The rule specifies the exact records that should be maintained by Combination Product and Constituent Part Applicants and for how long. Mandatory Information to be included in Combination Product PMSR Reports The Combination Product PMSR Reports should include the following

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  • March 3, 2021
  • Posted by: Techsol Life Sciences
  • Category: MedTech
No Comments
MedTech

Today, more and more combination products are being developed to address the ever-increasing demands of patients who require more advanced and more effective treatments.

Earlier, traditional pharmaceuticals, medical devices, and biologics were the only options for treating the various medical conditions that people experienced. However, the steep rise in aging populations, has caused a shift in the healthcare industry. This shift is toward manufacturing products that can deliver more than what the traditional treatments currently provide. Combination products are one type of treatment option that can meet the more rigorous demands of today’s patients.

Definition of a Combination Product

Combination products are usually therapeutic and diagnostic products that combine drugs, devices or biological products. They consist of two or more regulated components. Each drug, device, and biological product included in a combination product is referred to as a constituent part of the combination product.

They can include several combinations such as:

  • Drug/device
  • Biologic/device
  • Drug/biologic
  • Drug/device/biologic
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Examples of Combination Products are metered-dose inhalers co-packaged with a filled drug product cartridge, vaccines supplied as a pre-filled syringe and drug-eluting stents.

The Growing Demand for Combination Products

Patients are demanding more innovative drugs which can help cure their ailments. Modern day patients are insisting on speedy delivery of therapeutics, ease of use and affordability. These demands made the drug companies to focus on the invention and production of Combination Products.

Combination Products are now integral to the drug manufacturing industry. According to the Globe Newswire Global Forecast, the Drug Device Combination Product market is expected to reach 177.7 billion USD by 2024.

Given this forecast, the manufacturing companies have a responsibility to safely meet patients’ expectations, continuously improve and monitor the production and use of these products.

Safety Reporting for Combination Products

As the demand for combination products increases and more products are introduced into the market, it has become a growing concern for National Competent Authorities (NCAs) and Pharma companies to report and track device malfunction adverse events. There are several cases where the FDA has issued many warning letters to pharmaceutical and device manufacturing companies to maintain safety and quality in their systems. For instance: Recently, the cardiac implants of a Medical Device giant received alerts from FDA about two dangerous security flaws affecting a number of implantable devices.

Such instances are a Heads Up for Global Drug Safety Departments to:

  • Take up extensive safety processing for combination products to ensure effective compliance.
  • Create separate departments logging quality complaints and performing initial and final review
  • Monitor recordkeeping requirements that enable safety data archiving
  • Conduct continuous research and progressive development to fulfill patient needs

In today’s highly competitive and informative scenario, there is a strong focus on Postmarketing Safety Reporting (PMSR) requirements for Combination Products. Increased efforts have been made to understand the evolving global regulations and to determine the best compliance strategies.

Reporting and Tracking of Adverse Events

Adverse Event Reporting Process

Marketing and Regulatory Requirements for Combination Products

Based on the type of scenario or event received, drug companies have to submit different reports to Notified bodies. Some of the prominent reports are 15 day reports, malfunction reports, 5 day reports, periodic reports, field alert reports and biological product deviation reports (BPDRs).

Companies also need to submit several applications to the relevant agencies before they can market their combination products.

The Marketing Applications required for Combination Products are:

  • NDA – Report to CDER
  • BLA – Report to CBER
  • PMAs- To legally sell CLASS III
  • PDPs
  • HDEs
  • De Novo Classification Requests (De Novos)
  • 510(k)s – To legally sell CLASS II

Assigning Combination Products for Review

A Combination Product is assigned to a particular FDA lead center that has primary jurisdiction for its premarket review and regulation. The Primary Mode of Action (PMOA) of a combination product is determined before its assignment to a FDA center as required under section 503(g)(1) of the FD&C Act.

Section 503(g) defines the PMOA as ‘the single mode of action of a combination product that provides the most important therapeutic action of the combination product’.

Even after a combination product is assigned to a lead center, all applicable centers coordinate with each other and the Office of Combination Products for post market safety reporting if the need arises.

General Considerations for Combination Product PMSR Compliance

FDA issued the final rule on postmarketing safety reporting (PMSR) requirements for combination products on December 20, 2016 (81 FR 92603). The rule, as codified in 21 CFR 4, Subpart B, describes the method of compliance with PMSR requirements for combination products that have received FDA marketing authorization.

The final rule addresses combination products that are subject to premarket review by FDA. The entities subject to the final rule are ‘Combination Product Applicants’ and ‘Constituent Part Applicants’

The most important aspects of the final rule are:

  • Application Type-Based Reporting Requirements: These requirements apply to both Combination Product Applicants and Constituent Part Applicants, based on the application type under which the combination product or constituent part has received marketing authorization.
  • Constituent Part-Based Reporting Requirements: These requirements apply only to Combination Product Applicants and are based on the types of constituent parts included in the combination product.
  • Information Sharing. Constituent Part Applicants have to share certain postmarketing safety information which they receive with each other.
  • Submission Process: The final rule specifies the exact process of submitting Combination Product and Constituent Part Applicants PMSR information to the Agency.
  • Streamlined reporting: The rule specifies certain ways to meet specific reporting requirements together in the same report.
  • Records Retention: The rule specifies the exact records that should be maintained by Combination Product and Constituent Part Applicants and for how long.

Mandatory Information to be included in Combination Product PMSR Reports

The Combination Product PMSR Reports should include the following information:

  • Combination Product Identifier: Clearly indicate that the report is for a combination product.
  • Report Type: Mention the type of report for all the reports that are submitted. If one submission is made to cover multiple reporting requirements, identify each report type.
  • Patient Identifier: Provide a patient identifier. If there is no patient involved in the event, enter ‘None.’
  • Reporter Identifier: Provide the identifier for the individual who provided the report to the Combination Product Applicant.
  • Suspect Medical Device: Include the procode that matches with the constituent parts of the device along with the device common name and/or brand name as applicable.
  • Suspect Drug or Biological Product: Specify the known product attributes for the drug or biological product constituent parts. Include these drug or biological product attributes even if the drug or biological product constituent part was implicated in the event or not. For NDA/ANDA/BLA approved combination products, include the combination product’s application number in this field.
  • Adverse Event Coding:
    • For Device Application combination products, enter at least one Patient Problem Code, or a descriptive term if there is no code.
    • For NDA/ANDA/BLA combination products, enter Reaction/Event Coding. Always use MedDRA (Medical Dictionary for Regulatory Activities) terms.
  • Device Problem Code. Identify at least one device problem code.
  • Cross-Reference to Other Reports: Mention the details of similar reports of international standards.

Future of Combination Products

More and more companies are collaborating to produce Combination Products. These partnerships provide patients with more innovative and affordable options.

According to informed surveys, approximately one-third of all medical products in development today are combination products. The field is an exciting one for device makers, not only because of the business opportunities, but because combination products have the ability to transform medicine as they have the potential to reverse diseases and not merely slow or stop the progression of diseases.

The growth factors for combination products come from many different sources. The most important among them is the fact that combination products can extend the patent life of a drug. When a drug’s patent is about to expire, it can be combined with a device or biologic to create a new product, with a new patent protection timeframe. Another strong factor is that there are less formal regulations governing combination products because the field is relatively new.

The availability of numerous products and technologies that can be combined to form combination products is tremendous. Exponential growth in this area is definitely on the cards as more products and technologies are developed and approved.

References

https://www.ivtnetwork.com/article/combination-products%E2%80%94engineering-future-healthcare

https://www.fda.gov/combination-products/about-combination-products/frequently-asked-questions-about-combination-products

https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products

Postmarketing Safety Reporting for Combination Products Final Guidance –

https://www.fda.gov/media/111788/download

https://www.fda.gov/combination-products/about-combination-products

https://www.fda.gov/media/132096/download

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