The European Commission (EC) has presented a proposal to amend the timeline of the future…
More EUDAMED modules now available
The EUDAMED system has now two new modules available: UDI/Devices and NBs & Certificates. This…
Updated EC Implementation Rolling Plan (MDR/IVDR)
The European Commission released an updated Implementation Rolling Plan under the Regulations 2017/745 and 2017/746…
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…
IVDs Expert Panel is operational!
Today, 3rd September 2021, the European Commission announced an important update regarding the implementation of…
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…
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…