Transitional provisions
Article 2
1. A product for which the manufacturer intends to perform, or is performing, a clinical investigation to generate clinical data for the clinical evaluation in order to confirm the conformity with the relevant general safety and performance requirements set out in Annex I to Regulation (EU) 2017/745 and the common specifications set out in this Regulation, and in the conformity assessment of which a notified body has to be involved in accordance with Article 52 of that Regulation, may be placed on the market or put into service until 22 June 2028, provided that the following conditions are met: (a) the product was already lawfully marketed in the Union before 22 June 2023 and continues to comply with the requirements of Union and national law that were applicable to it before 22 June 2023; (b) there are no significant changes in the design and intended purpose of the product. By way of derogation from the first subparagraph of this paragraph, from 22 June 2024 until 22 December 2024, a product that meets the conditions laid down in that subparagraph may only be placed on the market or put into service, if the sponsor has received from the Member State concerned a notification, in accordance with Article 70(1) or (3) of Regulation (EU) 2017/745, confirming that the application for the clinical investigation of the product is complete and that the clinical investigation falls within the scope of the Regulation (EU) 2017/745. By way of derogation from the first subparagraph, from 23 December 2024 until 22 June 2026, a product that meets the conditions laid down in that subparagraph may only be placed on the market or put into service, if the sponsor has started the clinical investigation. By way of derogation from the first subparagraph, from 23 June 2026 until 22 June 2028, a product that meets the conditions laid down in that subparagraph may only be placed on the market or put into service, if a written agreement for the performance of the conformity assessment has been signed by the notified body and the manufacturer. 2. A product for which the manufacturer does not intend to perform a clinical investigation, but in the conformity assessment of which a notified body has to be involved in accordance with Article 52 of that Regulation, may be placed on the market or put into service until 22 June 2025, provided that the following conditions are met: (a) the product was already lawfully marketed in the Union before 22 June 2023 and continues to comply with the requirements of Union and national law that were applicable to it before 22 June 2023; (b) there are no significant changes in the design and intended purpose of the product. By way of derogation from the first subparagraph, from 22 September 2023 until 22 June 2025, a product that meets the conditions laid down in that subparagraph may only be placed on the market or put into service, if a written agreement for the performance of the conformity assessment has been signed by the notified body and the manufacturer. 3. A product to which this Regulation applies and which is covered by a certificate issued by a notified body in accordance with Directive 93/42/EEC may be placed on the market or put into service until the dates laid down in paragraph 1, first subparagraph, and paragraph 2, first subparagraph, as applicable, also after the expiry date of such certificate, provided that the following conditions are met: (a) the product was already lawfully marketed in the Union before 22 June 2023 and continues to comply with the requirements of Directive 93/42/EEC, except for the requirement to be covered by a valid certificate issued by a notified body where the certificate expires after 26 May 2021; (b) there are no significant changes in the design and intended purpose of the product; (c) after the expiry date of the certificate issued by a notified body in accordance with Directive 93/42/EEC, the appropriate surveillance of the compliance with the conditions referred to in points (a) and (b) of this paragraph is ensured by way of a written agreement signed by the notified body that has issued the certificate in accordance with Directive 93/42/EEC or a notified body designated in accordance with Regulation (EU) 2017/745 and the manufacturer.