A need for separate legislation EDMA analysis of proposed regulation on in vitro diagnostic medical devices

The European Diagnostics Manufacturers Association, EDMA, welcomes the Commission Proposal for a Regulation on in vitro diagnostic medical devices (IVDs) and its intention to strengthen the current system for the sake of patient safety, while still guaranteeing a competitive and innovative environment for manufacturers. EDMA supports in particular the choice of a Regulation as the legal instrument, in order to ensure the harmonised application and interpretation across all EU Member States.

In this position paper, EDMA suggests further improvements to the Proposal, which aim to strengthen patient safety, facilitate the effective use of IVDs by healthcare systems and support the industry to develop and bring IVDs to patients.

We encourage the European Parliament and the Council of the EU to integrate these improvements as the Proposal moves through the legislative procedure.

EDMA also seizes this opportunity to clarify what IVDs are, their role in healthcare and how they are different from other healthcare products.