Navigating the Future of Medical Devices: A Deep Dive into the European Commission’s MDR Revision and Industry Proposals for a More Efficient and Innovative Landscape The European Commission has officially announced the launch of the Medical Device Regulation (MDR) revision, a welcome development for the industry. This initiative, communicated by European Commissioner for Health, Olivér…
European Commission guidelines for the optimal drafting of the summary of the clinical investigation report under the MDR The European Commission recently published the “Commission Guidelines on the Content and Structure of the Summary of the Clinical Investigation Report” (2023/C 163/06). These guidelines provide guidance on how to prepare the summary of the clinical investigation…
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…