Notified Bodies developments
Posted on 09.12.2020
The European Commission has published MDCG 2020-17 Questions and Answers related to MDCG 2020-4 . As a reminder, MDCG 2020-4 (dated April 2020) is the “Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions”, which in summary clarifies circumstances under which remote/virtual audits are allowed under the Directives.
While it seems that MDCG Q&A 2020-17 does not address virtual audits in place of on-site audits in times of pandemics under the Regulations, “all” medical devices under the Directives are now allowed to be remotely audited, not only the clinical COVID-19 relevant ones.
Also, since 27 November, the fifth IVD Notified Body is listed under the IVD Regulation in the NANDO database: TÜV Rheinland LGA Products GmbH (NB#0197), Germany.
For the Medical Devices, the 18th Medical Device (MD) Notified Body was officially designated under the MD Regulation and included in the European Commission NANDO database: UDEM Adriatic d.o.o. (NB#2696), Croatia.
Summary of the NB designation situation:
• 18 notifications under the MDR
• 5 notifications under the IVDR