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…
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IVDs Expert Panel is operational!
Today, 3rd September 2021, the European Commission announced an important update regarding the implementation of…
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…
IVDR: 6th Notified Body on NANDO!
The NANDO database is richer for a new Notified Body under the IVDR! GMED SAS…
Class D IVDR: Clarification on “first certification for that type of device” by MDCG
The MDCG has endorsed a guidance providing clarification on the conditions and corresponding procedures notified bodies need to apply when determining if…
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…
COVID-19 IVDs: MDCG Guidance on performance evaluation
The MDCG has endorsed a 2021-21 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic…
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 /…
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