CE Marking

EU Authorised Representative Services for Medical Device & IVD Manufacturers

Leave a Comment / Authorised Representative, Blog, CE Marking, Client Questions, EU Regulations, EUDAMED, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, Quality Assurance, Quality Management, UK Regulations /

Selling medical devices or IVDs in Europe? If your company is based outside the EU, appointing an EU Authorised Representative (EC Rep) is a legal requirement under EU MDR 2017/745 and IVDR 2017/746. Patient Guard provides expert EU Authorised Representative services, EUDAMED support, regulatory guidance, and ongoing compliance management to help manufacturers access and maintain the European market with confidence.

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CE Marking and Supply Chain Responsibilities

Authorised Representative, Blog, CE Marking, Client Questions, EU Regulations, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, Quality Assurance, Quality Management, UK Regulations, UK Responsible Person /

When it comes to selling medical devices in Europe, most people assume that CE marking is the manufacturer’s responsibility alone. While it’s true that the manufacturer plays the lead role, distributors are not off the hook.

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IVD

IVD Directive Essential Requirements vs. IVDR GSPR: How to Transition Your Checklist

Blog, CE Marking, Client Questions, EU Regulations /

The shift from the In Vitro Diagnostic Directive (IVDD 98/79/EC) to the In Vitro Diagnostic Regulation (IVDR EU 2017/746) represents a fundamental overhaul of how technical files are structured. Under the legacy Directive, manufacturers relied on an Essential Requirements Checklist to demonstrate safety and performance. Under the IVDR, this has been completely replaced by the General Safety and Performance Requirements (GSPRs) found in Annex I.

If you are updating a legacy device technical file or migrating a quality management system, you cannot simply copy and paste your old compliance arguments. The GSPRs require a much higher degree of clinical evidence, lifecycle risk tracking, and technical specificity.

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