The competent national authorities have identified several common issues while implementing market surveillance activities (presented…
IVDR: New harmonised standards
The Commission Implementing Decision (EU) 2022/15 of 6 January 2022 amending Implementing Decision (EU) 2021/1195…
The European Parliament and the Council of the EU adopt IVDR progressive roll-out!
The two co-legislators of the European Union: the European Parliament and the Council of the…
Distributors and importers: new MDCG Q&A
The MDCG has published a new Q&A document with the aim to provide more details…
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…
25 MDR Notified Bodies & EUDAMED Implementing Act
The NANDO database newly lists 25 Notified Bodies under the MDR! SGS Belgium NV has been…
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…