Between 8 May and 5 June 2023, medical device stakeholders can submit feedback on the amendment of common specifications for products without intended medical purpose. Annex XVI of the Medical Devices Regulation (MDR) lists devices without intended medical purpose. Specifically, the drafted amendment addresses the transitional provisions for such products.
Amendment to common specifications of Annex XVI devices
The proposed draft would change the transitional provisions for medical devices without an intended medical purpose. Such devices include breast implants, coloured contact lenses, liposuction devices, and similar.
The proposed changes are:
Paragraph 1 of Article 2
- 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 (instead of 22 June 2028) if:
- From 22 June 2024 until 22 December 2024: manufacturers can place such products on the market or put them into service if the sponsor has received confirmation that the application for the clinical investigation of the product is complete, and that the clinical investigation falls within the scope of the MDR.
- From 23 December 2024 until 31 December 2027 (instead of 22 June 2026), manufacturers can place such products on the market or put them into service only if the sponsor has started the clinical investigation.
- From 1 January 2028 until 31 December 2029 (replacing the fourth subparagraph), manufacturers can place such products on the market or put them into service if there is a written agreement with a notified body for the conformity assessment in accordance with the requirements set in Annex VII (paragraph 4.3 of the MDR).
Paragraph 2 of Article 2
- Manufacturers can place products for which they do not intend to perform a clinical investigation – but assessed by a notified body – on the market or put them into service until 31 December 2028 (instead of 22 June 2025) if:
- From 1 January 2027 until December 2028 (replacing the second subparagraph), manufacturers can place such products on the market or put them into service if there is a written agreement with a notified body for the conformity assessment in accordance with the requirements set in Annex VII (paragraph 4.3 of the MDR).
Paragraph 3 of Article 2
- 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 if they meet the extension requirements.
Article 3
- The second sentence of the second subparagraph is removed.
Feedback period
The draft act is open for feedback for four weeks. The last day to submit feedback is 5 June 2023 (midnight Brussels time). Following the opinions, the Commission will adopt the act by 22 June 2023.
MDlaw Library of Documents includes all public consultations and relevant documents.
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