In previous articles we have highlighted the low number of Notified Bodies as one of the medical device industry's most pressing concerns ahead of the date of application of the EU MDR1, which is now only weeks away.
It was announced earlier this month that Finland's Eurofins Expert Services Oy has been designated as the 20th EU MDR Notified Body. The number of IVDR2 designated Notified Bodies remains at a paltry four. The full lists of all EU MDR and IVDR Notified Bodies can be found on the EU's NANDO database.
You may recall than in June 2019, we noted that the European Commissioner for Health and Food Safety, Vytenis Andriukaitis, stated that the regulatory regime will be ready and functional in time for the original May 2020 deadline. At that time, Mr Andriukaitis estimated that 20 Notified Bodies will be approved by the end of 2019. More than 15 months later than originally predicted, this has been achieved.
In December 2020, the Commission stated that 90% of Notified Bodies designated under the soon to be defunct MDD3 were seeking designation under the MDR and that 71% of those designated under the IVDD4 were seeking IVDR designation. In March 2021, the Commission published an updated overview of the notified bodies currently being assessed for EU MDR and IVDR designation. This document reveals a large number of Notified Bodies are in the queue but as we know COVID-19 has stalled progress as on-site audits are required in the final stage of designation.
In response to COVID-19 constraints, the Commission announced in January that it would permit Notified Bodies to conduct remote audits when granting MDR and IVDR certificates. At the time this was music to the ears of industry bodies such as Team NB, who had called for the Commission to step in and ease the certification bottleneck. Unfortunately for Team NB, it quickly transpired that the EU member states did not agree on the subject of remote auditing and as a result the notice did not crystallise as MDCG5 guidance. In this absence of agreement, the Commission has left it up to the individual member states to decide whether or not they permit remote auditing.
1. Medical Device Regulation (EU) 2017/745
2. In Vitro Diagnostic Regulation (EU) 2017/746
3. Directive 93/42/EEC
4. Directive 98/79/EC
5. EU Commission's Medical Device Coordination Group
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