The MDCG has published a new Q&A document with the aim to provide more details…
New MDCG guideline & template: Modification to Clinical investigations
The Medical Device Coordination Group (MDCG) has issued a new guidance on clinical investigations under…
25 MDR Notified Bodies & EUDAMED Implementing Act
The NANDO database newly lists 25 Notified Bodies under the MDR! SGS Belgium NV has been…
Norwegian legislation on medical devices: MDR implementation
The Regulation (EU) 2017/745 on medical devices (MDR) was implemented into national law of Norway…
EUDAMED: NB & Certificates – Useful documents
EUDAMED or the European database on medical devices has been designed to support the implementation…
Timeline for MDCG guidance documents updated
The European Commission has released the updated document on the ongoing work of the MDCG…
MDCG Q&A on repackaging/relabelling and MDR legacy requirements
The Medical Device Coordination Group has issued two very useful guidances for importers and distributors…
MDR: 24 Notified Bodies on NANDO
The NANDO database newly lists 24 Notified Bodies under the MDR! CERTIQUALITY S.r.l. has been the…
New MDCG Guidance on classification of medical devices under MDR
The MDCG has published a very important Guidance on classification of medical devices under the MDR – Regulation (EU) 2017/745: MDCG 2021-24. The…
More EUDAMED modules now available
The EUDAMED system has now two new modules available: UDI/Devices and NBs & Certificates. This…