October 14th, 2021, the European Commission proposed a progressive roll-out of the IVDR to prevent disruption in the supply of IVD products to the market . The proposal does not change any requirements of the IVDR in substance but changes the transitional provisions stipulated in Article 110, to allow a progressive rollout.

Postponing the date of application of the IVDR by 1 year would not resolve the challenges linked to the IVDR’s implementation. Two of the main challenges are the limited notified body capacity in combination and the vast number of devices that need to undergo a conformity assessment involving a notified body. This work should thus ideally be spread over a longer period, allowing for a gradual phase-in of the IVDR’s requirements while prioritising high-risk IVDs. The proposed extended transitional provisions will furthermore ensure that the transitional periods under the MDR and IVDR do not end at the same time, hereby lessening the strain on Member States’ competent authorities, notified bodies, manufacturers, health institutions and other actors who deal with both medical devices and IVDs.

There is no change for CE-marked devices that do not require notified body involvement under the IVDR or for devices that are “new” to the market, i.e., devices that have neither a notified body certificate nor a declaration of conformity under the current IVD Directive 98/79/EC. For the aforementioned type of devices, the IVDR will apply from 26 May 2022 as planned.

The proposed amendment aims to extend the existing transitional period for devices covered by a notified body certificate issued under IVD Directive 98/79/EC until 26 May 2025 (Article 110 (2)). In article 110 (3) it introduces tailored transitional periods for devices that were self-declared under the IVD Directive 98/79/EC, and for which a Declaration of Conformity was drawn up prior to 26 May 2022, which will have to undergo a conformity assessment involving notified bodies for the first time under the IVDR. The length of the proposed transitional periods depends on the type of device. Class D devices have until 26 May 2025, Class C until 26 May 2026, and Class B and sterile Class A devices have until 26 May 2027. The devices must, from the date of application of the IVDR (26 May 2022), continue to comply with the IVD Directive 98/79/EC and no significant changes in their design and intended purpose are to be made. From the IVDR date of application, the requirements of the IVDR relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply.

To allow IVDs which are placed on the market in accordance with the newly proposed transitional provisions sufficient time to be further made available on the market, including to be supplied to the end users, or to be put into service, the sell-off date provided for in article 110 (4) has been adapted to consider the additional transitional periods and now ranges from 26 May 2025 until 26 May 2028.

The proposal also introduces a transitional period for the requirements for devices manufactured and used within the same health institution (“in-house devices”). The requirements stipulated in article 5 (5) points (b), (c) and (e) to (i) will only apply from 26 May 2024. The requirement for the justification that there is no equivalent CE marked device available to meet the target patient group's specific needs (article 5(5) point (d)) is proposed to be deferred even further, until 26 May 2028, as the health institutions will need an overview of CE-marked IVDs available on the market to comply with this requirement.
The Proposal will now go to the European Parliament and Council for adoption.

What does this mean to you?

If the proposal is adopted, without any changes, then this will provide manufacturers with more time to transition the existing devices from the IVD Directive 98/79/EC to the IVDR 2017/746. With more time to prepare for the application of the EU new rules, the European Commission ensures there is a continuous supply of essential IVDs on the market, while not compromising on safety. It is still highly advisable for all manufacturers to prepare for certification under the IVDR as soon as possible and not wait until the end of the transition period.

Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.

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