The COVID-19 pandemic highlighted the need of a centralized management system in the health sector to…
MDR: 23 Notified Bodies on NANDO
The NANDO database newly lists 23 Notified Bodies under the MDR! TUV Rheinland Italia SRL…
Reprocessing of single-use devices, clinical investigations and offences under MDR: Ireland
The text of the Medical Device Regulation (MDR) became directly applicable on the European Union…
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…
EU MDR v. CH MedDO: How are medical devices regulated on the Swiss market?
Due to the absence of the Mutual Recognition Agreement between the EU and Switzerland on…
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…
First harmonised standards under MDR& IVDR are now available!
The European Commission has published in the Official Journal of the European Union (OJEU) the…
MDCG Guidance note: UDI within organization’s QMS
The MDCG has released a new Guidance note on how to implement the MDR /…
MDR: 21 Notified Bodies on NANDO!
The NANDO database newly lists 21 Notified Bodies under the MDR! KIWA CERMET ITALIA S.P.A.…
MDCG Q&A on EUDAMED Actor registration for importers (update)
The MDCG has released a revised version of Questions & Answers document clarifying actor registration…