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…
Notified Bodies survey on MDR/IVDR certifications and applications
The European Commission has released updated data from the survey conducted among Notified Bodies on certifications and applications under the Medical Devices Regulation (MDR) and…
MDR: 40th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi is the 40th EU Notified Body…
Switzerland: revision of MedDO for products with aesthetic functions
Similar to Annex XVI of the EU Medical Devices Regulation (MDR), since May 2021, the Swiss Medical Devices Ordinance regulates certain products that have an…
IVDR: 12th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! Sertio Oyis the 12th EU Notified Body notified under the Regulation (EU) 2017/746…