Much of the content of the new European Union In Vitro Diagnostics Regulation (EU IVDR) 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 31-46 in Chapter VI (replacing Article 15 of the In Vitro Diagnostics Directive (IVDD) and the new Annex VII (replacing Annex IX of the IVDD), 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 IVDR will be largely unchanged compared to how they have been operating under the IVDD since 2013.
The following are among the changes for Notified Bodies which are likely to have the biggest potential impact for Manufacturers;
The new Article 41 introduces a requirement for Competent Authorities to routinely review a sample of the assessments of technical documentation and performance evaluations performed by their Notified Bodies.
Whereas the new Article 50 requires the Competent Authorities to automatically review the conformity assessment report, whenever a Notified Body issues a certificate for a class D device.
Within the transitional arrangements, the new Article 110 renders all existing (IVDD) Notified Bodies void on the 26th May 2022. While this introduces the spectre that many of the Notified Bodies who are currently approving devices under the IVDD 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, probably until 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.
The new Article 110 does however allow Notified Body certificates issued before the 26th May 2017 to remain valid until their expiry date (or at the latest until the 26th May 2024). Similarly, certificates issued after the 26th May 2017 will also remain valid until their expiry date (or at the latest the 26th May 2024).