MedTech Europe position on the proposed draft Standardisation Request for In-vitro Diagnostic Medical Devices (IVD) Regulation (2017/746/EU) and Medical Devices (MD) Regulation (2017/745/EU)

MedTech Europe supports the harmonisation of standards to support the implementation of the In-Vitro Diagnostic Medical Devices (IVD) and Medical Devices Regulation. The present document aims at outlining a number of concerns including limited flexibility, resourcing and expected timing of the harmonisation process. MedTech Europe urges Member States, Notified Bodies and National Standards Organisations to support the integrity of healthcare systems by raising these concerns to the European Commission.