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Regulation

Commission Implementing Regulation (EU) 2023/1194 of 20 June 2023 amending Implementing Regulation (EU) 2022/2346 as regards the transitional provisions for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council (Text with EEA relevance)

CELEX
Implementing Regulation (EU) 2023/1194
Date of document
Articles
2
Source
EUR-Lex
Article 1

Implementing Regulation (EU) 2022/2346 is amended as follows:

(1)

Article 2 is amended as follows:

(a)

paragraph 1 is amended as follows:

(i)

in the first subparagraph, the date ‘22 June 2028’ is replaced by ‘31 December 2029’;

(ii)

in the third subparagraph, the date ‘22 June 2026’ is replaced by ‘31 December 2027’;

(iii)

the fourth subparagraph is replaced by the following:

‘By way of derogation from the first subparagraph, from 1 January 2028 until 31 December 2029, 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 in accordance with Section 4.3, second subparagraph, of Annex VII to Regulation (EU) 2017/745.’;

(b)

paragraph 2 is amended as follows:

(i)

in the first subparagraph, the date ‘22 June 2025’ is replaced by ‘31 December 2028’;

(ii)

the second subparagraph is replaced by the following:

‘By way of derogation from the first subparagraph, from 1 January 2027 until 31 December 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 in accordance with Section 4.3, second subparagraph, of Annex VII to Regulation (EU) 2017/745.’;

(c)

paragraph 3 is replaced by the following:

‘3.   A product which was covered by a certificate issued by a notified body in accordance with Directive 93/42/EEC that expired after 26 May 2021 and before 20 March 2023, and for which the conditions laid down in Article 120(2), second subparagraph, point (a) or (b), of Regulation (EU) 2017/745 are not met, may be placed on the market or put into service until the dates laid down in Article 120(3a) of Regulation (EU) 2017/745, also after the expiry of the certificate, provided that the conditions set out in Article 120 (3c), (3d) and (3e), of Regulation (EU) 2017/745 are met.’

;

(2)

in Article 3(2), the second sentence is deleted.

Article 2

This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union .

It shall apply from 22 June 2023.

2 articles

Cite this act

Commission Implementing Regulation (EU) 2023/1194 of 20 June 2023 amending Implementing Regulation (EU) 2022/2346 as regards the transitional provisions for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council (Text with EEA relevance) (EUR-Lex). Retrieved via LawPlayer, https://lawplayer.com/eu/act/32023R1194

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

EU-EurLex-Reuse-2011-833

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