The expert panel on medical devices and in-vitro diagnostic devices (EXPAMED) has published a new Opinion in the context of the performance evaluation consultation procedure…
25 MDR Notified Bodies & EUDAMED Implementing Act
The NANDO database newly lists 25 Notified Bodies under the MDR! SGS Belgium NV has been the latest NB notified under the Regulation (EU) 2017/745 on…
EUDAMED: NB & Certificates – Useful documents
EUDAMED or the European database on medical devices has been designed to support the implementation of the EU Medical Devices Regulations. EUDAMED is composed of…
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 progress has been achieved. For example, The necessary implementing acts…
Timeline for MDCG guidance documents updated
The European Commission has released the updated document on the ongoing work of the MDCG and its subgroups. We present you below some of the…
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 on repackaging and relabelling activities under MDR and IVDR as…
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 In Vitro Devices Regulation 2017/746 for certain IVDs. More specifically,…
More EUDAMED modules now available
The EUDAMED system has now two new modules available: UDI/Devices and NBs & Certificates. This allows Economic Operators and Notified Bodies to start entering data…
Updated EC Implementation Rolling Plan (MDR/IVDR)
The European Commission released an updated Implementation Rolling Plan under the Regulations 2017/745 and 2017/746 with the list of implementing acts/actions to take with different…
HERA: New European Health Emergency preparedness and Response Authority
The COVID-19 pandemic highlighted the need of a centralized management system in the health sector to ensure that the EU and the Member States are ready…