The European Commission issued a proposal (COM/2021/627) on 14 October 2021 to amend the transitional implementation periods under EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR). On 1 December 2021, the Council of Europe (the Council) approved and confirmed this proposal and notably, did so without amending the European Commission’s draft text. The proposal was adopted by the European Parliament in a plenary session on 16 December 2021 at first reading without amendments and subsequently approved by the Council on 21 December. The fact that neither the Council nor the European Parliament made any amendments to the proposal allowed for expedient and accelerated adoption of these revised transitional provisions.

The aim of the adopted text is to prevent supply disruption of these essential healthcare products as the COVID-19 pandemic continues to play out.

The potential for disruption to the supply chain is exacerbated by the fact that only six notified bodies have been designated under the IVDR so far. This means that there is currently an acute shortage of notified body capacity to carry out the necessary conformity assessments to establish that in vitro diagnostic medical devices (IVDs) meet the safety and performance requirements under the IVDR.

The amendment will not change IVDR requirements or its date of application. However, it will update the transitional provisions to allow for a progressive and more realistic rollout of the IVDR given the circumstances.

The IVDR will apply in full from 26 May 2022. Article 110 of the IVDR outlines the transitional period for the adaptation from the EU Medical Devices Directive 98/79/EC (IVDD) to the IVDR. It currently states that devices lawfully placed on the market through a certificate issued by a notified body, in accordance with the IVDD prior to 26 May 2022, can be made available or put into service until 26 May 2024.

The adopted text recognises the significant challenges faced by economic operators in seeking to adapt to the changes introduced by the IVDR. As a result, it extends the existing transitional period for devices covered by a certificate issued by a notified body under the IVDD. It also introduces specific transitional periods for devices that must undergo a conformity assessment involving a notified body for the first time under the IVDR.

Under the amendment to Article 110(3) of the IVDR, the transitional period for IVDs with a certificate issued by a notified body in accordance with the IVDD and which is valid by virtue of Article 110(2) of the IVDR has been extended by one year to 26 May 2025.

The new transitional periods introduced under the amendment to Article 110(3) of the IVDR apply to IVDs that:

• Do not currently require notified body involvement in the conformity assessment procedure under the IVDD, but will require this under the IVDR
• Have a declaration of conformity issued under the IVDD prior to 26 May 2022. The extended transitional period will depend on the class of the device
• Existing higher risk class D and class C devices under the IVDD may be placed on the market or put into service until 26 May 2025 and 26 May 2026 respectively, and
• Existing devices classified as class B under the IVDD, and class A devices in a sterile condition, may be placed on the market or put into service until 26 May 2027

Devices placed on the market, or put into service under the extended transitional periods outlined above, must continue to comply with the IVDD from the date of application of the IVDR. They must not have any significant changes made in their design and intended purpose. These devices must also comply with the requirements of the IVDR relating to post-market surveillance, market surveillance, vigilance, registration of economic operators
and of devices.

The amendment to Article 110(4) of the IVDR reiterates that IVDs lawfully placed on the market under the IVDD prior to 26 May 2022 may continue to be made available on the market or put into service until 26 May 2025. However, IVDs lawfully placed on the market from 26 May 2022 under Article 110(3) of the IVDR may continue to be made available on the market or put into service until the following revised dates:

• 26 May 2026 for IVDs with a certificate that was issued in accordance with the IVDD, and which is valid by virtue of Article 110(2) IVDR, and class D devices referred to in Article 110(3)
• 26 May 2027 for class C devices referred to in Article 110(3), and
• 26 May 2028 for class B devices and class A devices placed on the market in sterile condition as referred to in Article 110(3)

The adopted text also defers the application of certain requirements for IVDs that are manufactured and used by the same health institution, in-house devices, until 26 May 2024 and 26 May 2028.[1] Requirement for in-house devices to provide justification that the target patient group’s needs cannot be met or met at the appropriate level of performance by a device available on the market will also not apply until the transitional periods laid down in the proposal have ended.

No extension is provided for IVDs that do not require notified body certification under the IVDR. Neither is an extension provided for IVDs that are ‘new’ to the market in that they have not been certified or declared for conformity under the IVDD. For these devices, and devices that have undergone a significant change in design or intended purpose, the IVDR will apply, in full, from 26 May 2022 as planned.

Note also that all IVDs, even those that will benefit from the new transitional periods, still have to comply with the IVDR’s revised rules on post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices from the original date of application, ie 26 May 2022.

Conclusion

The extension of the IVDR transition periods is a very welcome development for a sector that is going through exponential change, at a time when regulatory resources are limited. However, manufacturers should not interpret the adoption of the amendment as a green light to defer their IVDR compliance.

It must be noted that whilst the amendment has been adopted, not all devices will benefit from an extension. IVDR vigilance, surveillance and registration requirements must still be met by the original deadline of May 2022. Accordingly, manufacturers should prepare for certification under the IVDR now as a matter of priority and not wait until the end of the transition period.

For more information, please contact a member of our Life Sciences team.

[1] Article 5(5), points (b), (c) and (e) to (i) IVDR will apply from 26 May 2024 and Article 5(5), point (d) IVDR will apply from 26 May 2028.

The content of this article is provided for information purposes only and does not constitute legal or other advice.