EuroGentest Network Response to the European Commission Proposal for a Regulation on IVD Medical Devices

EuroGentest Network Response to the European Commission Proposal for a Regulation on IVD Medical Devices

Ensuring the quality of genetic testing is at the heart of EuroGentest’s mission. EuroGentest maintains that only high-quality, clinically and analytically valid diagnostic tests should be performed in clinical laboratories. We believe that IVD device regulation is an important part of the governance framework for ensuring the safety and effectiveness of genetic tests. We welcome the Commission’s new proposal for a regulation to replace the current Directive 9 8/79/EC on in vitro diagnostic medical devices. We are pleased that the proposal takes up a number of reforms which we have advocated, and we believe the draft regulation represents a major advance on the IVD Directive as a mechanism for ensuring the safety and effectiveness of IVD devices. However, we believe that some changes are required in order to enhance the proposal. In this briefing we outline what those changes are.

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