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…
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…
MDR: 44th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! RISE Medical Notified Body…
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…
Regulatory updates: January 2024
With the start of 2024, the EU, UK, and Swiss competent authorities provided new regulatory…
MDR & IVDR national implementing law: Iceland
The implementation of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Devices Regulation…
MDR: 43rd Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! CESKY METROLOGICKY INSTITUT a.…
New Team-NB position paper on medical device lifetime
Team-NB has released a document to clarify the concept of “medical device lifetime”. The Medical…
Updated MDCG Guidance on clinical investigation
A clinical investigation can demonstrate a medical device’s safety and clinical performance. In December 2023,…