Article 1
Open ↗Regulation (EU) 2017/746 is amended as follows: (1) Article 110 is amended as follows: (a) paragraph 2 is amended as follows: (i) in the first subparagraph, the date ‘27 May 2024’ is replaced by ‘27 May 2025’; (ii) in the second subparagraph, the date ‘27 May 2024’ is replaced by ‘27 May 2025’; (b) paragraphs 3 and 4 are replaced by the following: ‘3. By way of derogation from Article 5 of this Regulation, the devices referred to in the second and third subparagraphs of this paragraph may be placed on the market or put into service until the dates set out in those subparagraphs, provided that, from the date of application of this Regulation, those devices continue to comply with Directive 98/79/EC, and provided that there are no significant changes in the design and intended purpose of those devices. Devices with a certificate that was issued in accordance with Directive 98/79/EC and which is valid by virtue of paragraph 2 of this Article may be placed on the market or put into service until 26 May 2025. Devices for which the conformity assessment procedure pursuant to Directive 98/79/EC did not require the involvement of a notified body, for which a declaration of conformity was drawn up prior to 26 May 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: (a) 26 May 2025, for class D devices; (b) 26 May 2026, for class C devices; (c) 26 May 2027, for class B devices; (d) 26 May 2027, for class A devices placed on the market in sterile condition. By way of derogation from the first subparagraph of this paragraph, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply to devices referred to in the second and third subparagraphs of this paragraph, instead of the corresponding requirements in Directive 98/79/EC. Without prejudice to Chapter IV and paragraph 1 of this Article, the notified body that issued the certificate referred to in the second subparagraph of this paragraph shall continue to be responsible for the appropriate surveillance in respect of all applicable requirements relating to the devices it has certified. 4. Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022 may continue to be made available on the market or put into service until 26 May 2025. Devices lawfully placed on the market from 26 May 2022 pursuant to paragraph 3 of this Article may continue to be made available on the market or put into service until the following dates: (a) 26 May 2026, for devices referred to in paragraph 3, second subparagraph, or in paragraph 3, third subparagraph, point (a); (b) 26 May 2027, for devices referred to in paragraph 3, third subparagraph, point (b); (c) 26 May 2028, for devices referred to in paragraph 3, third subparagraph, points (c) and (d).’; (2) in Article 112, second paragraph, the date ‘27 May 2025’ is replaced by ‘26 May 2028’; (3) in Article 113(3), the following points are added: ‘(i) Article 5(5), points (b) and (c) and (e) to (i), shall apply from 26 May 2024; (j) Article 5(5), point (d), shall apply from 26 May 2028.’.