Between 8 May and 5 June 2023, medical device stakeholders can submit feedback on the amendment of common specifications for products without intended medical purpose.…
UK recognises extended CE Certificates
The UK is taking new steps to recognise the extended CE Certificates in light of the recent amendment of the MDR and IVDR transitional periods.…
Q&A on extension of the MDR transitional period and removal of the “sell off” period
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…
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 transitional provisions for certain medical devices and in vitro diagnostic…
European Parliament accepts Proposal for extension of legacy period
On February 16, 2023, the European Parliament voted in favour of the Proposal to prolong the transitional provisions for certain medical devices and in vitro…
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 Guidance on Period Safety Update Report (PSUR) under MDR
Manufacturers of class IIa, class IIb, and class III medical devices have to prepare a Period Safety Update Report (PSUR) for each device or group…
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…