EXPAMED publishes its new Opinion on Performance Evaluation Consultation procedure (PECP)
The expert panel on medical devices and in-vitro diagnostic devices (EXPAMED) has published a new…
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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…
IVDR Implementation plan: What is the status of the main priorities?
The MDCG has released the updated Joint implementation and preparedness Plan for IVDR noting significant…
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…
The European Commission is proposing to give more time to certain IVDs to reach IVDR compliance!
The European Commission (EC) has presented a proposal to amend the timeline of the future…
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…
New labeling obligations under the MDR
Compared to the MDD 93/42/EEC, the new Medical Devices Regulation EU 2017/745 (MDR) sets out…
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