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.…
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…
IVDs Expert Panel is operational!
Today, 3rd September 2021, the European Commission announced an important update regarding the implementation of the In Vitro Diagnostic Medical Devices Regulation- 2017/746. The expert…
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…
IVDR: 6th Notified Body on NANDO!
The NANDO database is richer for a new Notified Body under the IVDR! GMED SAS is the 6th EU Notified Body notified under the Regulation…