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…
Notified Bodies survey on MDR/IVDR certifications and applications
The European Commission has released updated data from the survey conducted among Notified Bodies on…
MDR and IVDR national implementation: Slovakia
The Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostics Devices Regulation 2017/746 (IVDR)…
IVDR: 12th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! Sertio Oyis the…
EUDAMED delay announced!
The European Commission has officially announced a delay in the full implementation of the EUDAMED…
MDCG Guidance on Medical Device Software (MDSW) – Hardware combinations
The Medical Device Coordination Group (MDCG) endorsed in October 2023 a new guidance on medical…
Classification of medical devices: Which legal provisions and guides to consider?
A key moment in the compliance process of products is their classification. It is the…
IVDR: 11th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! Eurofins Electric & Electronics…