Today, 21 June 2023, the Official Journal of the European Union published the final text for the new legacy period of Annex XVI devices. Annex XVI devices are devices without an intended medical purpose covered by the Medical Devices Regulation (MDR).
Transitional provisions for devices without an intended medical purpose
As anticipated in the draft published in May 2023, the new amendments are confirmed to be:
Paragraph 1 of Article 2 (need for a clinical trial)
- Manufacturers can place products for which they intend to perform, or are performing, a clinical investigation on the market or put them into service until 31 December 2029 if:
- By 22 June 2024: the sponsor has received confirmation from the Member State concerning their clinical trial authorization request;
- By 23 December 2024: the sponsor has started a clinical investigation;
- By 1 January 2028: the manufacturer has signed a written agreement with a notified body for the conformity assessment procedure;
- From 22 June 2023 until 31 December 2029:
- the product must have been lawfully marketed in the European Union before 22 June 2023 and continue to comply with the applicable requirements;
- the manufacturer has not made significant changes in the design and purpose of the product;
Not meeting any of the above dates will result in the end of the transitional period. Furthermore, the confirmation of the application of a clinical trial must come from an EU Member State.
Paragraph 2 of Article 2 (no need for a clinical trial, but NB involvement is mandatory)
- Manufacturers can place products for which they do not intend to perform a clinical investigation – but need to be assessed by a notified body – on the market or put them into service until 31 December 2028 if:
- By 1 January 2027: the manufacturer has signed a written agreement with a notified body for the conformity assessment in accordance with the requirements set in Annex VII.
Paragraph 3 of Article 2 (CE Certificate by NB issued)
- Manufacturers of products with a Certificate issued under the Directive and expired after 26 May 2021 and before 20 March 2023 can place such products on the market and put them into service until 31 December 2027/2028 depending on the class if they meet the extension requirements.
Article 3
- The second sentence of the second subparagraph is removed.
Original timeline and conditions that did not change can be found here. This new Commission Regulation will start applying on 22 June 2023.
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