Following numerous attempts made by our Medtech industry including SYMATESE, EU ratifies to extend Transitional Periods for Medical Devices. On February 16, 2023, the European Parliament adopted legislation amending the implementing provisions of the European Union (EU) Medical Device Regulation (MDR). SYMATESE and its subsidiaries will now be able to plan the transition of their products to MDR compliance until December 31, 2027 for all Class III and Class IIb devices and until December 31, 2028 for Class IIa devices. The practical provisions for the extension of current CE markings by the Notify Body will be the subject of a communication from the European Commission. It is expected that a confirmation letter issued by the Notify Body including the list of products will be published.
Jean-Paul Gerardin, CEO of Symatese declares “We have all been waiting for this news for some time, which will allow us to ensure the continuity of the availability on the market of our medical devices marketed for years, recognized for their reliability and their safety”.