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.
Your Definitive Guide to CE Marking
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.
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.
The Irish NSAI expects approval to get the EU MedTech
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.
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 (EUDAMED) for the EU and additional registration requirements for the Republic of Ireland. What is the status?
The European Commission confirms: it is preparing a proposal to postpone the implementation of the Medical Device Regulation (EU) 2017/745 with one year.
Today, the European Union’s advisory organ for medical devices, the