Much of the content of the new European Union Medical Device Regulation (EU MDR) is not actually new, but brings the European legislation up to date with the current expectations of the European Authorities and the current practices of the Notified Bodies. The sections dedicated to Notified Bodies are a prime example of this.
Primarily addressed to the European Competent Authorities, the new Articles 35-50 of Chapter VI (replacing Article 16 of the Medical Device Directive (MDD)) and the new Annex VII (replacing Annex XI of the MDD), make permanent the measures introduced as part of the so called “PIP action plan” in 2013. Namely, the Commission Implementing Regulation “on the designation and the supervision of notified bodies” and the Commission Recommendation “on the audits and assessments performed by notified bodies”. This means that the Notified Bodies’ mandate under the new EU MDR will be largely unchanged compared to how they have been operating under the MDD since 2013.
The biggest potential changes with impact for Manufacturers in relation to Notified Bodies lie elsewhere in the new EU MDR.
The new Article 54 introduces a new “consultation procedure” for Notified Bodies, under which they must submit the Clinical Evaluations of certain high risk devices to an expert panel for review.
Similarly, the new Article 55 introduces a new “mechanism for scrutiny of conformity assessments” for certain high-risk devices. Both of these new obligations on Notified Bodies are likely to impact the approval times of the affected Class III and Class IIb devices.
Within the transitional arrangements, the new Article 120 renders all existing (MDD) Notified Bodies void on the 26th May 2021. While this introduces the spectre that many of the Notified Bodies who are currently approving devices under the MDD might no longer exist. In practice, those Notified Bodies that have survived the changes introduced in 2013 are likely to remain Notified Bodies under the new EU MDR. That said, the confirmation of the designation of the Notified Bodies under the new EU MDR is likely to take some time. This means that all Notified Bodies will face some uncertainty until probably mid 2018 at the earliest. Not least those Notified Bodies currently notified by the United Kingdom, where the 2016 Referendum on EU membership leaves their future as Notified Bodies even more uncertain than those in other EU countries.
Article 120 does however allow Notified Body certificates issued before the 26th May 2017 to remain valid until their expiry date or at the latest until 26th May 2022. Whereas Certificates issued after the 26th May 2017 remain valid until their expiry date or until the latest 26th May 2024.