Progressive roll-out of IVDR adopted

December 20^th, 2021, the European Parliament and Council adopted the European Commission’s proposal for a progressive roll-out of the IVDR without any changes. This amending Regulation does not change any requirements of the IVDR in substance but only changes the transitional provisions stipulated in Article 110, to allow a progressive rollout. The existing transitional period for devices covered by a certificate issued under IVD Directive 98/79/EC have been extended until 26 May 2025 and tailored transitional periods have been introduced for devices that must undergo a conformity assessment involving notified bodies for the first time under the IVDR. The length of the 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. Furthermore, the amending Regulation introduces a transitional period for the requirements for devices manufactured and used within the same health institution (‘in-house devices’).

The amending Regulation does not introduce any changes 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 amending Regulation extends 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 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 new 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 amending Regulation 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 amending Regulation will need to be published before it fully takes effect.