By Fajar Dumadi | October 20, 2021
According to the Regulation (EU) 2017/746 (IVDR) (1) the industry was given until 26 May 2022 to fully implement the regulation; it is required to have the product CE marked by the stipulated deadline.
However, according to the market surveys conducted in 2021 by notified bodies and the trade association MedTech Europe, there are over 24,000 IVDs that will require the involvement of a notified body. From the 520 certification applications received by notified bodies (this covers roughly 9,600 devices) 95% certificates are yet to be issued. Currently, there are only 6 notified bodies designated. Although the EU authorities insisted that there will be no delay for IVDR, the slow pace of notified bodies designation has proven otherwise.
In October 2021, a proposal to amend the Regulation (EU) 2017/746 (IVDR) was approved (2). Under this proposal, the following amendments are proposed:
1. Certificates issued in accordance with Annex VI to Directive 98/79/EC shall become void by May 27, 2025.
2. Certificates issued by notified bodies in accordance with Directive 98/79/EC from May 25, 2017 shall become void by May 27, 2025.
3. Devices for which the conformity assessment procedure pursuant to Directive 98/79/EC did not require the involvement of a notified body, a declaration of conformity was drawn up prior to May 26, 2022 in accordance with that directive, and for which the conformity assessment procedure pursuant to this regulation requires the involvement of a notified body, may be placed on the market or put into service until the following dates:
- 26 May 2025 for class D devices
- 26 May 2026 for class C devices
- 26 May 2027 for class B devices
- 26 May 2027 for class A devices placed on the market in sterile condition.
4. Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to May 26, 2022 may continue to be made available on the market or put into service until May 26, 2025.
However, these amendments will only benefit devices that require a notified body certificate under Directive 98/79/EC. The transitional period is differentiated between risk classes to balance the notified body capacity with high level of public health protection.
On the other hand, The IVDR is not postponed and the general application date of the regulation remains May 26, 2022, especially for CE marked in-vitro diagnostic medical devices that do not require the involvement of a notified body (i.e. class A non-sterile devices which represent around 20% of the market) and for ‘new’ in-vitro diagnostics (i.e. those not covered by a certificate or a manufacturer’s declaration of conformity issued prior to 26 May 2022).
- The European Parliament and The Council of The European Union. EUR-Lex – 02017R0746-20170505 – EN. EUR-Lex (Access to European Union Law). [Online] May 5, 2017. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0746-20170505.
- EUR-Lex – 52021PC0627 – EN. EUR-Lex – Access to European Union Law. [Online] October 14, 2021. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A52021PC0627.