In June 2023, the Official Journal of the European Union published the common specifications for…
New flowchart on the scope of MDR legacy period extension
On 23 August 2023, the European Commission has released a new flowchart to assist manufacturers…
NB Position Paper on the new MDR transition timelines
On 10 August 2023, Team-NB, the European Association of Medical Devices Notified Bodes, published a…
European Commission updates factsheet for non-EU/EEA authorities
The European Commission has published an updated factsheet for authorities in non-EU/EEA states on medical…
Updated MDCG Guidance on significant changes (MDR transitional provision)
On 12 May 2023, the Medical Device Coordination Group (MDCG) published the revised Guidance on…
Feedback on amendment of common specifications for products without intended medical purpose
Between 8 May and 5 June 2023, medical device stakeholders can submit feedback on the…
UK recognises extended CE Certificates
The UK is taking new steps to recognise the extended CE Certificates in light of…
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),…
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…