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…
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…
Class D IVDR: Clarification on “first certification for that type of device” by MDCG
The MDCG has endorsed a guidance (updated September 2022) providing clarification on the conditions and corresponding procedures notified bodies need to apply when determining if an expert panel consultation 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 medical devices for the conformity assessment under IVDD and IVDR.…
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…