Extension of transitional provisions related to in vitro diagnostic medical devices (IVD)
On 26 May 2021, the EU regulation on medical devices came into force. On 26 May 2022, one year later, the time has come to look at in vitro diagnostic medical devices (IVD), and so Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVD) has become applicable, thus replacing the EU’s current IVD Directive (Council Directive 98/79/EEC).
Despite great attempts to have the IVD regulation ready by 2022, the implementation has faced a number of challenges. Particularly the COVID-19 pandemic required an extra effort by everyone, and, moreover, the IVD supply chain difficulties, the lack of IVD-designated notified bodies and the delay in appointing reference laboratories have been causes for concern.
Moreover, interest groups in the EU have reported the significant uncertainty to be hampering their members’ planning and preparation of compliance with the IVD regulation as early as May 2022. Therefore, in October 2021, the Commission proposed to extend the transitional provision (article 110) of the regulation for certain products. Read more about the changes below. The new transitional provisions were adopted by the European Parliament and the Council on 25 January 2022.
The IVD regulation will still become applicable on 26 May 2022.
Changes in the new transitional provisions:
- Certificates issued before 25 May 2017 in accordance with the EC verification procedure set out in Annex VI to the directive will become void in 2025, and certificates issued by a notified body after 25 May 2017 in accordance with the directive will become void no later than 27 May 2025.
- In terms of IVDs which did not require the involvement of a notified body under the directive, but for which a declaration of conformity has been drawn up before 26 May 2022 and which are required to involve a notified body under the regulation, these may be placed on the market or put into service until the following dates:
- 26 May 2025 as regards class D devices
- 26 May 2026 as regards class C devices
- 26 May 2027 as regards class B devices
- 26 May 2027 as regards class A devices which are placed on the market in sterile condition.
- IVDs manufactured and used only within health institutions in accordance with article 5(5) (the in-house rule) are subject to the following changes:
- 5(5) (b) and (c) will apply from 26 May 2024
- 5(5) (e) to (i) will apply from 26 May 2024
- 5(5) (d) will apply from 26 May 2028
IVDs lawfully placed on the market from 26 May 2022 may continue to be made available on the market or put into service until the dates referred to in subsection 4 (a) to (c) of the IVD regulation.
Devices not covered by new transitional provisions
- IVDs with a certificate from a notified body under the IVD directive, and which do not require assessment by a notified body under the IVD regulation (class A , non-sterile devices under IVDR)
- All new IVDs certified and marketed after 26 May 2022. Please note that although ‘in-house’ IVDs are not certified, the transitional provisions are highly relevant for those manufactured and used in accordance with article 5(5) after 26 May 2022.
The transitional provisions ensure comprehensive coverage of different IVDs used in the healthcare sector while rolling out the legislation and enhancing patient safety. Ensuring patient access to safe and effective IVDs must be the focal point of the implementation efforts.
Read the new transitional provisions here.