Regulatory Framework for Medical Devices: Key Updates

Latest Regulatory Updates on Medical Devices: What You Need to Know to Stay Compliant The medical devices sector is constantly evolving, driven by both technological advancements and the regulatory complexity governing the market. Adding to the complexity is the fact that medical devices are sometimes subject to intersecting regulations, such as Regulation (EU) 2017/745 (MDR),…

Clinical investigation report: MDR guidelines

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…