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Unofficial consolidated textConsolidated 2025-01-10English

Article 113

Reproduced from official EUR-Lex 10/1/2025.

Article 113

Entry into force and date of application

1.

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

2.

It shall apply from 26 May 2022.

3.

By way of derogation from paragraph 2:

  1. (a)

    Articles 26(3) and 51(5) shall apply from 18 months after the later of the dates referred to in point (f);

  2. (b)

    Articles 31 to 46 and Article 96 shall apply from 26 November 2017. However, from that date until 26 May 2022 the obligations on notified bodies pursuant to Articles 31 to 46 shall apply only to those bodies which submit an application for designation in accordance with Article 34;

  3. (c)

    Article 97 shall apply from 26 May 2018;

  4. (d)

    Article 100 shall apply from 25 November 2020;

  5. (e)

    for class D devices, Article 24(4) shall apply from 26 May 2023. For class B and class C devices Article 24(4) shall apply from 26 May 2025. For class A devices Article 24(4) shall apply from 26 May 2027;

  6. (f)

    without prejudice to the obligations of the Commission pursuant to Article 34 of Regulation (EU) 2017/745, the obligations and requirements that relate to any of the electronic systems referred to in Article 30(2) of this Regulation shall apply from the date corresponding to 6 months from the date of publication of the notice referred to in Article 34(3) of Regulation (EU) 2017/745, informing that the relevant electronic system is functional and meets the functional specifications drawn up pursuant to Article 34(1) of that Regulation. The provisions referred to in the preceding sentence are:

    1. Article 26,

    2. Article 28,

    3. Article 29,

    4. the second sentence of Article 36(2),

    5. Article 38(10),

    6. Article 39(2),

    7. the second subparagraph of Article 40(12),

    8. points (d) and (e) of Article 42(7),

    9. Article 49(2),

    10. Article 50(1),

    11. Article 51(5),

    12. Articles 66 to 73,

    13. Article 74(1) to (13), without prejudice to Article 74(14),

    14. Articles 75 to 77,

    15. Article 81(2),

    16. Articles 82 and 83,

    17. Article 84(5) and (7) and the third subparagraph of Article 84(8),

    18. Article 85,

    19. Article 88(4), (7) and (8),

    20. Article 90(2) and (4),

    21. the last sentence of Article 92(2),

    22. Article 94(4),

    23. Article 110(3d).

    Until the date of application of the provisions referred to in the first subparagraph of this point, the corresponding provisions of Directive 98/79/EC regarding information on vigilance reporting, performance studies, registration of devices and economic operators, and certificate notifications shall continue to apply.

  7. (fa)

    no later than 6 months from the date set out in point (f), first subparagraph, of this paragraph, manufacturers shall ensure that the information to be entered in Eudamed in accordance with Article 26 is entered in the electronic system referred to in Article 30(2), points (a) and (b), including regarding the following devices, provided that those devices are also placed on the market from the date set out in point (f), first subparagraph, of this paragraph:

    1. (i)

      devices for which the manufacturer has undertaken a conformity assessment in accordance with Article 48;

    2. (ii)

      devices placed on the market pursuant to Article 110(3), (3a) or (3b), unless the device, for which the manufacturer has undertaken a conformity assessment in accordance with Article 48, is already registered in Eudamed;

  8. (fb)

    no later than 12 months from the date set out in point (f), first subparagraph, of this paragraph, notified bodies shall ensure that the information to be entered in Eudamed in accordance with Article 51(5) is entered in the electronic system referred to in Article 30(2), point (d), including regarding devices referred to in point (fa)(i) of this paragraph; for those devices, only the latest relevant certificate and, where applicable, any subsequent decision taken by the notified body related to such certificate shall be entered;

  9. (fc)

    by way of derogation from point (f), first subparagraph, of this paragraph, the obligations to upload the summary of safety and performance in accordance with Article 29(1) and to notify competent authorities in accordance with Article 50(1), through the electronic system referred in Article 30(2), point (d), shall apply to devices referred to in point (fa) of this paragraph when the certificate is entered in Eudamed in accordance with point (fb) of this paragraph;

  10. (fd)

    without prejudice to point (f), first subparagraph, of this paragraph, when a manufacturer is to submit a PSUR in accordance with Article 81(2) of this Regulation, to report a serious incident or a field safety corrective action in accordance with Article 82 of this Regulation, or to submit a trend report in accordance with Article 83 of this Regulation through the electronic system referred to in Article 30(2), point (f), of this Regulation, it shall also register the device, which is the subject of the PSUR or the vigilance reporting, in the electronic system referred to in Article 30(2), points (a) and (b), of this Regulation, except if such device was placed on the market in accordance with Directive 98/79/EC;

  11. (g)

    the procedure set out in Article 74 shall apply from 26 May 2029 without prejudice to Article 74(14);

  12. (h)

    Article 110(10) shall apply from 26 May 2019;

  13. (i)

    Article 5(5), points (b) and (c) and (e) to (i), shall apply from 26 May 2024;

  14. (j)

    Article 5(5), point (d), shall apply from 31 December 2030.