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…
MDR: 24 Notified Bodies on NANDO
The NANDO database newly lists 24 Notified Bodies under the MDR! CERTIQUALITY S.r.l. has been the latest NB notified under the Regulation (EU) 2017/745 on medical…
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,…
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 document mainly analyzes the classification rules of Annex VIII of the…
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…
New labeling obligations under the MDR
Compared to the MDD 93/42/EEC, the new Medical Devices Regulation EU 2017/745 (MDR) sets out additional requirements manufacturers need to adhere to for device labeling.…