Staggering of transition periods for the regulation on in vitro diagnostic medical devices

As already sufficiently known, the IVDR 2017/746 will replace Directive 98/79/EC (IVDD) on 26.05.2022 according to the current plan. Now, on 14.10.2021, news reached us that will probably relieve many manufacturers of medical devices, but also other economic actors, users and patients.
Together with the MDCG, DG Sante, which is responsible for medical devices in the EU, created a joint implementation plan for the IVDR in June 2021, indicating that surveys had identified bottlenecks in the implementation of the IVDR and that the need for intervention on the part of the legislator had been recognized.

Based on this, there is now a proposal from the EU Commission to amend the In Vitro Diagnostics Regulation 2017/746.
Among other things, it has been recognized that with the IVDR, many more manufacturers will need a Notified Body for their medical devices (over 24,000 products versus 3,300 products under the IVDD, source: md_2017-746-regulation_2021-amendment_en.pdf [europa.eu]). To date, however, there are only six Notified Bodies for the IVDR, with eleven applications currently on hold (as of 10/20/2021, source EUROPA – European Commission – Growth – Regulatory policy – NANDO).

It has also been recognized that simply postponing the applicability deadline for the regulation of in vitro diagnostic medical devices would be insufficient or possibly counterproductive. For comparison: in the context of the postponement of the MDR, the Notified Bodies had to deal more with applications for the extension of MDD certificates in the “gained year” than with the preparation and implementation of the MDR.

In the amendment proposal now on the table, the aim is to phase in IVDR 2017/746.
High-risk products are to be prioritized, and the validity period of IVDD certificates is to be extended by one year.

In very concrete terms, this would mean for in vitro diagnostics manufacturers:

Certificates issued before May 25, 2017, in accordance with Directive 98/79/EC, under Annex IV, will remain valid until May 27, 2025 – one year longer.
Likewise type examination certificates according to IVDD.

For devices that are newly classified by the IVDR and now require the involvement of a Notified Body for the first time, the following key dates shall apply with regard to the transition periods:

05/26/2025 – Class D

26.05.2026 – Class C

26.05.2027 – Class B

05/26/2027 – Sterile Class A

Until these deadlines, devices could be placed on the market with a declaration of conformity according to 98/79/EC, as long as the declaration of conformity was issued before 26/05/2022 and there were no relevant changes to the medical devices.

However, for all devices, the requirements for post-market surveillance, vigilance, and registration obligations under IVDR must still be considered as of 05/26/2022.

Regardless of this, manufacturers of Class D devices who now need a Notified Body for the first time should hurry. No certificate has yet been issued for a Class D device (as of 09/09/2021)!

The proposed changes do not imply extended deadlines for in vitro diagnostic devices that do not require the involvement of a Notified Body. These are on the one hand

non-sterile class A devices, which account for about 20% of the market (source: MedTech Europe Survey Report, footnote 2), as well as on the other hand

“new” in vitro diagnostic devices for which no certificate or declaration of conformity has yet been issued under Directive 98/79/EC.

The IVDR is scheduled to apply in full to these devices as of May 26, 2022.

More generally, it is advisable for IVD manufacturers not to deviate from the planned timetable now, as what has been described is so far only an amendment that has not yet been adopted by the EU. It is to be hoped, of course, that in view of the MDR experience, the penny has dropped that a staggered solution, such as the one proposed here, is probably more expedient than simply postponing the start date.

If you would like support in implementing the IVDR requirements now, regardless of political developments, we would be pleased to hear from you. We would be happy to support you in the already acute topics of PMS, Vigilance and Registration as well as in the later relevant topics such as Performance Assessment, Technical Documentation and Certification.

Please note that all details and listings do not claim to be complete, are without guarantee and serve purely as information.