CEN and CENELEC welcome the proposal from the European Commission to revise the Medical Devices Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR), supporting efforts to ensure a regulatory framework that is robust, transparent and sustainable, while continuing to safeguard public health and foster innovation.
As European Standardization Organizations, CEN and CENELEC develop European Standards that establish safety, quality and performance requirements for medical devices placed on the European market. Many of these standards support manufacturers in demonstrating compliance with European legislation in the medical sector, helping to ensure safe and innovative products for patients across Europe.
In our new position paper, CEN and CENELEC highlight the importance of an efficient, proportionate and coherent regulatory framework. The paper sets out key recommendations on topics including time-limited certificates, sampling procedures and the use of common specifications, with the aim of ensuring that safe and innovative medical technologies can reach patients across the Single Market.
Discover the full set of recommendations for the revision in the attached position paper.
