MDR: Devices Based on Substances

MDR: Innovations and Implications for Medical Devices Based on Substances Regulation (EU) 2017/745 has introduced significant innovations in the field of medical devices, particularly those composed of substances. However, the distinction between these and medicines can be blurred, leading to lengthy and complex discussions. The European Commission’s MDCG 2022-5 guide aims to clarify these contentious…

Medical Devices Regulations 2023: Updated Registration

Updates to Medical Devices Regulations 2023: Registration of Systems and Procedural Kits in the National Database As of October 26, 2023, significant changes have come into effect regarding the management of information related to medical devices, allowing for the input of data for both systems and procedural kits into the national database. This update is…