Gradual introduction of the regulation for in vitro diagnostic medical devices for "old" IVDD-CE-labeled products.

In addition, application conditions according to IVDR 2017/746 for health institutions fighting against COVID-19 pandemic by using in-house devices (specific regime for devices manufactured and used in the same health institution, which are not marketed or transferred to other legal entities and do not bear the CE marking) will be deferred.

The health institutions need a complete overview of CE-marked in vitro diagnostic medical devices available on the market. As laid down in the IVDR 2017/746, as now amended, the condition obliging the health institution to justify that the target patient group’s specific needs cannot be met, or cannot be met at the appropriate level of performance, by an equivalent device available on the market should not become applicable until the now extended transitional periods (otherwise until 26 May 2024). With a justification that target patient group's specific needs cannot appropriately be met by an equivalent in vitro diagnostic medical device available on the market the transitional period can be extended until 26 May 2028.

Regulation (EU) 2017/746 is amended according to Article 1 (of the amendment⁴), while the adoption of the amendment to the Regulation takes place under exceptional circumstances arising from the COVID-19 pandemic and the associated public health crisis.⁴

Devices for which the conformity assessment procedure pursuant to Directive 98/79/EC did not require the involvement of a notified body, for which a declaration of conformity was drawn up prior to 26 May 2022 in accordance with that Directive, and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, may be placed on the market, or put into service until the following dates:⁴

(a) 26 May 2025 for class D devices;
(b) 26 May 2026 for class C devices;
(c) 26 May 2027 for class B devices;
(d) 26 May 2027 for class A devices placed on the market in sterile condition.

IVD Regulation will continue to apply from 26 May 2022.

Overall, the IVD Regulation will apply as planned from May 26, 2022. No change is proposed for CE-marked devices that do not require the involvement of a notified body under the IVD Regulation or for "new" devices, i.e. devices that have neither a certificate from a notified body nor a declaration of conformity under the current Directive 98/79/EC. For these types of devices, the IVD Regulation will therefore apply as planned from May 26, 2022.⁴

In addition, from the date of application May 26, 2022, all IVDs lawfully placed on the market, are available on the market or put into service shall comply with requirements for Vigilance and PMS (Annex III, IVDR 2017/746), irrespective of the transition periods! Also, the provisions for registration of economic operators and of devices and data entry in EUDAMED are NOT affected by the transitional provisions.

IVDR 2017/746 undoubtedly sets higher standards for the safety, quality and performance of IVDs and fundamentally improves transparency (the European database already announced in Article 12 of Directive 98/79/EC) and - newly - the requirements for economic operators (manufacturers and importers) and the traceability system based on the unique device identifier (UDI). In addition, the IVDR drastically tightens the criteria and the designation and supervision of notified bodies (which - not unexpectedly⁵ - the reason for the current low number of notified bodies (NBs) accredited under the IVDR⁶ while there is currently only one NB in France, three NBs in Germany and two NBs in the Netherlands), causing a bottleneck.

In addition, the IVDR 2017/746 improves coordination mechanisms between EU countries on vigilance and post-market surveillance, tightens rules for clinical evidence and performance evaluation, including an EU-wide coordinated procedure for the approval of multicentre performance characteristic studies, and strengthens post-market surveillance requirements for manufacturers.⁷ As an example, the PSUR (Periodic Safety Update Reports) can be mentioned. The PSUR is intended to provide an assessment of the risk-benefit balance of a medical device at specific points in time after it has been approved.⁸ and has been known for years from the pharmacovigilance requirements for medicinal products. PSURs have now become mandatory for certain higher risk classes of IVDs.

Following the revision of the IVDR classification for more than 30 years, most notably the revision of the IVDR classification that ultimately (and for good reason) moved from Annex II/A, II/B, self-test and "other" or "general" medical device classes in the IVDD to classes A, B, C, D in the IVDR, as presented many years ago by the Global Harmonization Task Force (GHTF), the risk-based IVD medical device classification⁹ is now being adapted with IVDR 2017/746. As a result, around 80% of IVDs that are CE-marked in accordance with the IVDD (Directive 98/79/EC, IVD Self-Certification Declaration IVDs) are now subject to the supervision and involvement of NBs for CE marking.⁸

The prolongation of the transitional periods surely releases the pressure on IVD manufacturers and involved notified bodies. Still, achieving compliance to the new regulations remains a challenging task and bears tremendous effort for everybody involved.