The extension of the European Regulation 2017/745 (MDR) was published in the Official Journal With the publication in the Official Journal of the EU (number L080), the extension of the European Regulation 2017/745 (MDR) came into force. The amendment now applies to the entire Union, as stated in Article 1 of the MDR and IVDR.…
MDR extension: accepted proposal to amend European Regulation 2017/745 (MDR) The proposal to amend European Regulation 2017/745 MDR and European Regulation 2017/746 IVDR, announced on December 9 during the EPSCO meeting, has been approved. The main objective of European Regulation 2017/745 MDR (Medical Device Regulation) is to “establish a robust, transparent, predictable and sustainable regulatory…
Extension of the transition period: the proposal to amend the European regulation 2017/745 MDR The proposal to amend the European Regulation 2017/745 MDR and the European Regulation 2017/746 IVDR, announced on December 9 during the EPSCO meeting came earlier than expected and was already published on the European Commission’s Medical Device website on January 6.…