Product Certification: CE Marking

The European Union (EU) mandates medical device manufacturers to obtain CE marking after meeting the stipulated regulatory requirements around patient safety, product quality and performance. This certification verifies that a device meets all regulatory requirements of the medical devices directive (MDD), In vitro diagnostic device directive (IVDD) or active implantable medical device directive (AIMD) as they apply to your product.

When the manufacturer has signed the declaration of conformity, the device can be CE marked. The CE mark must be affixed visibly, legibly and indelibly on, for example, the instructions for use and symbolises that the product meets the requirements of the legislation.

The CE mark must also be affixed to the sales packaging and the device itself. In the case of a sterile device, the CE mark is placed on the package that keeps the device sterile. In the case of devices involving a notified body, the CE mark must be followed by an identification number of the notified body having assisted in the assessment of the product.

The model for CE marking appears from Annex V of the medical devices regulation.

With over 15+ years experience, our MedTech team has helped several pharma and medical device companies to obtain CE Marking for different classes of medical devices with the following capabilities:

CE Marking

How We Can Help

At Techsol, our expert team of MedTech professionals are specialists in completing a comprehensive MDD-MDR Gap Analysis and then performing product certification of medical devices. We provide specialized services to manufacturers, importers, distributors and healthcare institutions in regard to the accurate and complete implementation of the Medical Devices Regulation (‘MDR’). 

We execute the below process to obtain CE Marking for different classes of medical devices.

01. Product Qualification and Classification

Determine product's eligibility as a medical device and complete medical device classification based on medical purpose, duration of use, invasiveness, etc.

02. Implement a Risk Management System

Perform risk analyses as per the EN-ISO 14971 framework and establish a comprehensive Risk Management System to monitor proudcts after post-marketing.

03. Implement a Quality Management System

Work towards establishing a quality management system in accordance to the principles laid out in the EN-ISO 13485 standard through a Notified Body audit.

04. Prepare Technical Documentation

Compile the Technical File / Design Dossier to demonstrate the product’s compliance with applicable essential requirements and conformity assessment procedures.

05. Device Registration with Competent Authority

Provide support for the registration of medical devices (UDI) with National Competent Authorities and establish post-market surveillance and vigilance systems.

06. CE Marking Completion

Obtain the European CE Marking Certificate for the medical device and draft a Declaration of Conformity prior to affix the CE Marking. Establish oversight to ensure regulatory compliance.

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