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…
MDCG Explanatory note on IVDR codes
The MDCG has issued its 2021-14 Guidance related to assignment of codes to in vitro diagnostic medical devices, which is done by the manufacturer when…
MDCG Q&A on EUDAMED Actor registration for importers (update)
The MDCG has released a revised version of Questions & Answers document clarifying actor registration obligations in accordance with MDR Article 31 and IVDR Article…
Expert panels: First opinion on Class III implantable device released
What is the role of Expert panels? According to articles 106 and 48(6) of the Medical Device Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746…