The European Commission has released updated data from the survey conducted among Notified Bodies on…
Parliament approved the Artificial Intelligence Act
Today, 13 March 2024, the European Parliament approved the text of the Artificial Intelligence Act.…
MHRA on future UK law on medical devices
On 5 March 2024, the UK MHRA (Medicines and Healthcare Products Regulatory Agency) held the…
Team-NB issues recommendations on the classification of SARS-CoV-2 IVDs
Team-NB, the European Association of Medical Devices Notified Bodies, has released a position paper providing recommendations for…
Council adopts IVDR legacy extension and EUDAMED delay
On 14 February 2024, the Council of the European Union endorsed the European Commission’s proposal…
Notified Bodies Survey on MDR and IVDR certifications
In February 2024, the European Commission published the results of the sixth survey conducted until…
MDCG 2024-02 on EMDN updates
The Medical Device Coordination Group (MDCG) just published the second guidance of the year. MDCG…
EC Proposal to extend IVD legacy period and make EUDAMED mandatory sooner
On 23 January 2024, the European Commission published a Proposal to extend the IVDs legacy…
National language requirements in the EU for MDR & IVDR devices
The European Commission has released a table on the existing language requirements for manufacturers under…
IVDR Joint Implementation Plan has been published!
The Medical Devices Coordination Group (MDCG) has issued a joint implementation and preparedness plan for…