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.…
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…
MDR: 23 Notified Bodies on NANDO
The NANDO database newly lists 23 Notified Bodies under the MDR! TUV Rheinland Italia SRL has been the latest NB notified under the Regulation (EU)…
MDCG Guidance for NBs, importers, and distributors: QMS certification for relabelling & repackaging
Under Article 16(4) of the MDR and IVDR, a distributor or an importer that relabels (translates) or repackages a device shall get their Quality Management…
22 MDR Notified Bodies on NANDO and MDCG instructions on Clinical Investigation ID
The NANDO database newly lists 22 Notified Bodies under the MDR! EUROFINS PRODUCT TESTING ITALY S.R.L. has been the latest NB notified under the Regulation (EU)…
First harmonised standards under MDR& IVDR are now available!
The European Commission has published in the Official Journal of the European Union (OJEU) the Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on…
MDCG Guidance note: UDI within organization’s QMS
The MDCG has released a new Guidance note on how to implement the MDR / IVDR requirements related to the Unique Device Identification (UDI) system…