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…
MDR and IVDR national implementation: Slovakia
The Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostics Devices Regulation 2017/746 (IVDR)…
MDR: 40th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! Notice Belgelendirme, Muayene ve…
Switzerland: revision of MedDO for products with aesthetic functions
Similar to Annex XVI of the EU Medical Devices Regulation (MDR), since May 2021, the…
IVDR: 12th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! Sertio Oyis the…
What is the difference between a Clinical Study and Clinical Evaluation?
Under the Medical Devices Regulation 2017/745 (MDR), it is required for manufacturers to plan, conduct…
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…