EU MDR / IVDR Consulting

The new Medical Devices RegulationSearch for available translations of the preceding (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices RegulationSearch for available translations of the preceding link (EU) 2017/746 (IVDR) bring EU legislation into line with technical advances, changes in medical science and progress in law-making.

The new regulations create a robust, transparent, and sustainable regulatory framework, recognised internationally, that improves clinical safety and creates fair market access for manufacturers and healthcare professionals.  The European Commission intends to undertake a comprehensive evaluation of the MDR by May 2027.

EU MDR Timeline

Are you a medical device manufacturer looking to comply with the new European Union Medical Device Regulation (EU MDR) or In Vitro Diagnostic Regulation (IVDR)? Do you need expert guidance and support to navigate the complex regulatory requirements and ensure your products meet the highest safety and performance standards? Our team of experienced consultants can help.

EU MDR Timeline

At Techsol, we provide comprehensive EU MDR / IVDR consulting services to medical device companies of all sizes and specialties. Our team of regulatory experts, technical writers, and quality assurance professionals has a deep understanding of the new regulations and the unique challenges they pose for medical device manufacturers.

Why Choose Us?

PSUR Submissions | Techsol Life Sciences

How We Can Help

At Techsol, our expert team of Medical writers have an extensive research background, scientific knowledge, and ample experience in contributing to clinical development programs for global pharma companies. 

Following are the key focus areas where our medical writing team has the expertise to deliver high-quality services throughout the drug / device development lifecycle as per applicable regulatory guidelines:


Data Safety Monitoring Board | Techsol Life Sciences

EU MDR Gap analysis of existing product dossier

EU MDR/IVDR compliance strategy

Changes in Notified Bodies

Labelling review and updates

Tech file remediation

Design dossiers and renewals

EUDAMED database management

EU UDI implementation

Regulatory strategy & Project deliverables US/EU/CA/ROW

Marketing strategy support

EU-MDR Remediation Support

Medical Device Consulting

Update clinical documentation from MED DEV Rev 4 to EU MDR

Prepare robust Gap analysis at a detailed level for better Remediation execution

Utilizing teams and maintaining confidentiality in Risk Management files, Restricted Materials documentation updates

Verifying the need for PMCF and if needed, develop practical PMCF plans/designs

Labeling remediation (IFUs, Content update, Artwork changes

Remediation of Tech files (update or rewrite) & Publish

Biocompatibility Assessments & Write BERs

IVDR Implementation Steps




1. Scope and Plan

Interviews, benchmarks, checklists

Transition Planning, defining scope, timelines, methods, resources, structures, and tools including presentation to stakeholders

2. Gap Assessment

Impact assessment checklist for product, clinical and QMS

Master Impact Matrix

3. Portfolio Rationalization

Product Portfolio Analysis template and remediation/retire cost budget template

Report Product Portfolio Analysis including budget impact

4. Global Impact Analysis

Global Impact Analysis template

Global impact report country by country

5. Master Compliance Roadmap

• Master Implementation Plan template

• Project charter definition sheet

• Resource requirements template

• Steering committee report

• Master Implementation roadmap

• Governance model including project charters

6. Regulatory Training

• Specific in-house workshops

• Detailed workshops MDR transition formats

Alignment on changed SOP’s, and MDR compliance

7. Implementation of Roadmap

• Project charter progress sheet

• Project charter status dashboard

Implementation of the different charter projects

8. Effectiveness Check


Resolve any discrepancies

9. EU-MDR Compliance

Notified Body Checklist

Continued Compliance

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