MDCG publishes MDR Surveillance Guidelines
MDCG publishes MDR surveillance guidelines regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD.
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Extension of Delegated Powers MDR & IVDR?
Extension of Delegated Powers MDR and IVDR? – The European Commission wants to extend its delegated powers for five years. This is to be able to amend the MDR and IVDR where the text of the regulations allows.
Irish NSAI Expects Approval to get EU MedTech Certification
The Irish NSAI expects approval to get the EU MedTech
French & German warning: EU must extend MDR transition period
The French and the Germans warn: The EU must extend MDR transition period. This comes following a meeting with European Commission representatives in Paris on March 14, 2022.
MHRA launches public consultation on future of medical device regulation
People are being encouraged to contribute their views on changes to how medical devices will be regulated across the UK. Read about it here.
MDR Current Registration Requirements
MDR current Registration Requirements (EUDAMED) for the EU and additional registration requirements for the Republic of Ireland. What is the status?
The European Commission confirms proposal to postpone the MDR
The European Commission confirms: it is preparing a proposal to postpone the implementation of the Medical Device Regulation (EU) 2017/745 with one year.
Medical Device Regulation (MDR): new guidance documents published
Today, the European Union’s advisory organ for medical devices, the