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…
EPSCO meeting: commission discussed the future of medical devices With the adoption of the European Medical Device Regulation (MDR) 2017/745, the regulation for medical devices has changed dramatically. The main goal of the MDR (Medical Device Regulation) is to “establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, ensuring a high level…
CAMD announces efforts to avoid plausible future shortage of essential medical devices On October 20-21, 2022, the 51st meeting of the European Union Competent Authorities for Medical Devices (CAMD) was held in Prague under the Czech Presidency of the Council of the European Union. As a reminder, with the adoption of the European Medical Device…