MedTech Europe published a new position paper ahead of May 2025 deadline for Class D…
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…
First MDCG Guidance documents on Annex XVI products
In December 2023, the Medical Device Coordination Group (MDCG) published for the first time two…
Updated MDCG Guidance on clinical investigation
A clinical investigation can demonstrate a medical device’s safety and clinical performance. In December 2023,…
First EU Reference Laboratories designated under the IVDR!
The European Union designated on 5 December 2023 its first EU reference laboratories (EURL) for…
Supply of medical devices in the EU: Survey & EU Authorities position
The European Commission and Members States are putting forward more steps to address the supply…
EU and Italian authorities urge manufacturers to transition to MDR/IVDR in time
The Medical Device Coordination Group (MDCG) has issued a new revision of its notice to manufacturers…
MDR: 42nd Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! Scarlet NB B.V. is…
MDR: 41st Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! UDEM Uluslararasi Belgelendirme Denetim…
Notified Bodies survey on MDR/IVDR certifications and applications
The European Commission has released updated data from the survey conducted among Notified Bodies on…