Extension of MDD Certificate for Our Medical Devices for the Treatment of Gastroesophageal Reflux Disease (GERD) Based on Alginates The MDR regulation, effective from May 2017 and applicable from May 2021, governs medical devices in Europe. Deadline extensions allow the marketing of devices compliant with the Medical Devices Directive (MDD) until December 31, 2027, for…
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.…
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.…