EU Commission proposes new transition periods for certain products under IVDR

Due to the Corona crisis and the shortage of notified bodies, the EU Commission submitted a proposal to amend the in vitro diagnostic medical device Regulation EU 2017/746 ("IVDR") on October 14, 2021. In the meantime, the approval was adopted by the European Parliament. Therefore, it can be assumed that this will be published very soon in die Official Journal of the European Union and that the approval of the Council will follow.

Overview

The proposed amendment does not aim to postpone the date of application of the IVDR, i.e. 26 May 2022. In addition, substantive amendments will not be included. However, the proposed amendment aims to introduce different transition periods - depending on the classification of the product. Thereby, a gradual implementation of the IVDR for certain products is intended, in particular to avoid interruptions in the supply of important in devices. In a nutshell:

• In vitro diagnostic medical devices can continue to be placed on the market until May 26, 2025, provided that a valid certificate (i.e. involving the participation of a notified body) has been issued for such products before 26 May 2022 and in accordance with the provisions of Directive 98/79/EC.

• For in vitro diagnostic medical devices with a declaration of conformity issued in accordance with Directive 98/79/EC before 26 May 2022 and without the involvement of a notified body, but of which classification under the IVDR shall be carried out again with the involvement of a notified body, the following transitional periods will apply concerning the placing on the market of such devices, depending on the product class: Class D devices (such as HIV or hepatitis tests): 26 May 2025; Class C devices (e.g. certain influenza tests): 26 May 2026; Class B devices: 26 May 2027; and Class A sterile devices: 26 May 2027.

However, the transitional periods will only apply if the devices continue to meet the requirements of Directive 98/79/EC and no significant changes are made regarding design and intended use (as also provided in the Medical Device Regulation (MDR) concerning medical devices).

As set forth in the MDR, it likewise applies to the IVDR that, irrespective of the above-mentioned transitional periods, the obligations regulated in the IVDR about (post-)market surveillance, vigilance and registration already apply to all in vitro diagnostic medical devices as of 26 May 2022. Therefore, the proposed amendment does not affect devices that are (i) new, i.e. not yet approved under the existing directive, or (ii) for which the involvement of notified bodies is not required.

Outlook

The planned transition periods would give manufacturers significantly more time to introduce their products under the IVDR. Against the background that the approval of about 78% of in vitro diagnostic medical devices under the IVDR requires the involvement of a notified body, this time window is also urgently needed. However, the notified bodies are still - to put it mildly - overloaded with the examination and issue of MDR certificates. In addition, only six notified bodies are recognized under the IVDR. With regard to manufacturers from Switzerland of so-called legacy products, this proposed amendment should also be of high interest in view of the non-extended Mutual Recognition Agreement (MRA), whereby the Swiss manufacturers also become a third country manufacturer under the IVDR (our article about the MRA with regard to medical devices can also be accessed here.

Update: The Council has also approved the Commission's proposal. This means that the proposed transition periods will enter into force.