Version in force , Modified +652 −818§
Amended by Regulation (EU) 2024/1860 32024R1860 on EUR-Lex (external, EUR-Lex)
Explanation, written by a model and checked against the cited text
The list of exceptions to the repeal of Directives 90/385/EEC and 93/42/EEC has been restructured, consolidating what were previously four separate indents covering vigilance, clinical investigation, registration and certificate notification provisions into two combined indents that merge the corresponding provisions of both Directives together.
The repeal dates for these merged exceptions are no longer expressed as fixed offsets tied to Article 123(3)(d) alone, but instead as applying, as applicable, from the date referred to in Article 123(3)(d) in respect of the application of the obligations and requirements relating to specific electronic systems listed in Article 33(2), with different points of that Article assigned to each of the two merged indents.
The final indent repealing Article 9(9) of Directive 90/385/EEC and Article 11(13) of Directive 93/42/EEC with effect from 24 April 2020 remains unchanged.
Cited: Art. 122, v2 (external, EUR-Lex) · Art. 122, v1 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, before and after
Previous version, in force 20 March 2023 02017R0745-20230320 → this version, in force 9 July 2024 02017R0745-20240709
Article 122
Repeal
Without prejudice to Article 120(3) to (3e) and (4) of this Regulation, and without prejudice to the obligations of the Member States and manufacturers as regards vigilance and to the obligations of manufacturers as regards the making available of documentation, under Directives 90/385/EEC and 93/42/EEC, those Directives are repealed with effect from 26 May 2021, with the exception of:
Articles 8 and 10, Article 10b(1), points (b) and (c) of Article 10b(1), (c), and Article 10b(2) and Article 10b(3) (3) of Directive 90/385/EEC, and the obligations relating to vigilance and clinical investigations provided for in the corresponding Annexes, which are repealed with effect from the later of the dates referred to in point (d) of Article 123(3) of this Regulation;
Article 10a, point (a) of Article 10b(1) and Article 11(5) of Directive 90/385/EEC, and the obligations relating to registration of devices and economic operators, and to certificate notifications, provided for in the corresponding Annexes, which are repealed with effect from 18 months after the later of the dates referred to in point (d) of Article 123(3) of this Regulation;
Article 10, Article 14a(1), points (c) and (d) of (d), Article 14a(1), Article 14a(2), Article 14a(3) 14a(2) and (3) and Article 15 of Directive 93/42/EEC, and the obligations relating to vigilance and clinical investigations provided for in the corresponding Annexes, Annexes to those Directives, which are repealed repealed, as applicable, with effect from the later of the dates date referred to in Article 123(3), point (d) (d), of this Regulation in respect of the application of the obligations and requirements that relate to the electronic systems referred to in Article 123(3) 33(2), points (e) and (f), respectively, of this Regulation; Article 10a, Article 10b(1), point (a), and
Article 11(5) of Directive 90/385/EEC, Article 14(1) and (2), Article 14a(1), points (a) and (b) of Article 14a(1) (b), and Article 16(5) of Directive 93/42/EEC, and the obligations relating to registration of devices and economic operators, and to certificate notifications, provided for in the corresponding Annexes, Annexes to those Directives, which are repealed repealed, as applicable, with effect from 18 months after the later of the dates date referred to in Article 123(3), point (d) (d), of this Regulation in respect of the application of the obligations and requirements that relate to the electronic systems referred to in Article 123(3) 33(2), points (a) to (d), respectively, of this Regulation; and
Article 9(9) of Directive 90/385/EEC and Article 11(13) of Directive 93/42/EEC, which are repealed with effect from 24 April 2020.
As regards the devices referred to in Article 120(3) to (3e) and (4) of this Regulation, the Directives referred to in the first paragraph of this Article shall continue to apply to the extent necessary for the application of those paragraphs.
Notwithstanding the first paragraph, Regulations (EU) No 207/2012 and (EU) No 722/2012 shall remain in force and continue to apply unless and until repealed by implementing acts adopted by the Commission pursuant to this Regulation.
References to the repealed Directives shall be understood as references to this Regulation and shall be read in accordance with the correlation table laid down in Annex XVII to this Regulation.