Six industry associations on medical devices and healthcare have jointly signed an open letter on the mandatory use of EUDAMED. The six associations call for…
MedTech Europe’s recommendations on May 2025 deadline for Class D IVDs
MedTech Europe published a new position paper ahead of May 2025 deadline for Class D IVDs. These are IVD devices of the highest risk-class. They…
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 Devices Regulation (MDR) does not specifically provide a definition for…
First MDCG Guidance documents on Annex XVI products
In December 2023, the Medical Device Coordination Group (MDCG) published for the first time two guidance documents on Annex XVI devices. Annex XVI products are…
Updated MDCG Guidance on clinical investigation
A clinical investigation can demonstrate a medical device’s safety and clinical performance. In December 2023, the Medical Device Coordination Group updated the guidance on clinical…
First EU Reference Laboratories designated under the IVDR!
The European Union designated on 5 December 2023 its first EU reference laboratories (EURL) for vitro diagnostic devices. In July 2022, the European Commission opened…
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 of medical devices in the EU. In this context, a…
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 and notified bodies to ensure they timely comply with MDR and…
MDR: 42nd Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! Scarlet NB B.V. is the 42nd EU Notified Body notified under the Regulation (EU)…
MDR: 41st Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. is the 41st EU…