News Medtech Regulations Newsletter

Harmonisation of standards under the IVD Regulation and Medical Devices Regulation

Posted on 09.09.2021

MedTech Europe has published a position paper welcoming the approval of the Standardisation Request M/575 COMMISSION IMPLEMENTING DECISION of 14.4.2021 for the In Vitro Diagnostic Medical Devices Regulation and Medical Devices Regulation. While harmonised standards for medical devices and IVDs can now start to be cited in the EU Official Journal (and some few are shortly expected), there are several concerns about the process due to the way in which the Standardisation Request has been phrased. MedTech Europe has put together a set of recommendations to address these concerns.