Following the publication of the latest amendment to the Medical Devices Regulations (MDR and IVDR), the European Commission published a Q&A document to facilitate the…
Amendment to the MDR and IVDR transitional period is official!
Today, 20 March 2023, the Official Journal of the European Union published the latest amendment to the Medical Devices Regulations (MDR and IVDR). After the…
How MDCG 2022-18 applies in Switzerland: certification gaps and notification
Following the Council’s agreement on the new measures to implement the Medical Devices Regulation (MDR), the Medical Device Coordination Group (MDCG) published a position paper…
Legacy devices: European Commission adopts proposal to extend Transitional period & Certificates!
The European Commission has adopted a new proposal to give more time to certify medical devices, which affects legacy devices under Article 120.3 of the…
MDCG Position Paper on extension period for legacy devices
The previous 2024 deadline worried the medical devices sector. With foreseeable market disruptions and negative consequences for health systems and patients, the Council found new…