The NANDO database has a new Notified Body under the MDR! TÜV SÜD Danmark is…
MDR & IVDR national requirements: France
France has incorporated the Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostic Devices…
2024: Which MDCG guidance can we expect?
The European Commission has released the updated document on the ongoing work of the MDCG…
EU and Switzerland start negotiations to deepen bilateral relations
The European Commission and the Swiss Confederation announced on 18 March the start of negotiations…
Notified Bodies survey on MDR/IVDR certifications and applications – March update
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.…
MDCG Guidance on Clinical Investigation Plan
The Medical Devices Coordination Group (MDCG) released in March 2024 a new guidance on the…
MDR: 44th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! RISE Medical Notified Body…
MHRA on future UK law on medical devices
On 5 March 2024, the UK MHRA (Medicines and Healthcare Products Regulatory Agency) held the…
Notified Bodies Survey on MDR and IVDR certifications
In February 2024, the European Commission published the results of the sixth survey conducted until…