Considerations on the current process of harmonisation of standards under the IVD Regulation and Medical Devices Regulation

In this position paper, MedTech Europe welcomes the approval of the Standardisation Request M/575 COMMISSION IMPLEMENTING DECISION of 14.4.2021 for the In Vitro Diagnostic Medical Devices Regulation (“IVDR) and Medical Devices Regulation (“MDR”). The European Commission has worked closely with stakeholders and the standardisation organisations to ensure this achievement ahead of the MDR Date of Application. This paves the way for harmonised standards for medical devices and in vitro diagnostic medical devices (“IVDs”) to be cited in the EU Official Journal. To ensure that this publication is followed by a smooth and speedy process of harmonisation, MedTech Europe has put together a set of recommendations to be addressed to, and discussed with, the relevant parties, especially the European Commission.