Following the publication of the latest amendment to the Medical Devices Regulations (MDR and IVDR),…
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…
The Council accepts Proposal for extension of legacy period
On March 7, 2023, the Council of the European Union voted in favour of the new…
European Parliament accepts Proposal for extension of legacy period
On February 16, 2023, the European Parliament voted in favour of the Proposal to prolong…
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),…
MDCG Position Paper on extension period for legacy devices
The previous 2024 deadline worried the medical devices sector. With foreseeable market disruptions and negative…
New extensions to implement MDR: impact on legacy devices
The new Regulation on Medical Devices (MDR) entered into force in May 2021, replacing the…
EU IVDR v. CH IvDO: How are In Vitro Diagnostic Medical Devices regulated on the Swiss market?
The end of the Mutual Recognition Agreement On May 26, 2022, the new Regulation 2017/746…
Legacy devices: new MDCG guidance on NB surveillance & QMS
The Medical Device Coordination Group (MDCG) has published an important guidance establishing the activities to…