IVDR Article 110 — Transitional provisions

Article 110M1M3M4

Transitional provisions

From 26 May 2022, any publication of a notification in respect of a notified body in accordance with Directive 98/79/EC shall become void.

Certificates issued by notified bodies in accordance with Directive 98/79/EC prior to 25 May 2017 shall remain valid until the end of the period indicated on the certificate, except for certificates issued in accordance with Annex VI to Directive 98/79/EC which shall become void at the latest on M1 27 May 2025 ◄ .

Certificates issued by notified bodies in accordance with Directive 98/79/EC from 25 May 2017 that were still valid on 26 May 2022 and that have not been withdrawn thereafter shall continue to remain valid after the end of the period indicated on the certificate until 31 December 2027. Certificates issued by notified bodies in accordance with that Directive from 25 May 2017 that were still valid on 26 May 2022 and that have expired before 9 July 2024 shall be considered to be valid until 31 December 2027 only if one of the following conditions is fulfilled:

(a)

before the date of expiry of the certificate, the manufacturer and a notified body have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII to this Regulation for the conformity assessment in respect of the device covered by the expired certificate or in respect of a device intended to substitute that device;

(b)

a competent authority of a Member State has granted a derogation from the applicable conformity assessment procedure in accordance with Article 54(1) of this Regulation or has required the manufacturer, in accordance with Article 92(1) of this Regulation, to carry out the applicable conformity assessment procedure.

By way of derogation from Article 5 and provided the conditions set out in paragraph 3c of this Article are met, devices referred to in paragraphs 3a and 3b of this Article may be placed on the market or put into service until the dates set out in those paragraphs.

3a.

Devices which have a certificate that was issued in accordance with Directive 98/79/EC and that is valid by virtue of paragraph 2 of this Article may be placed on the market or put into service until 31 December 2027.

3b.

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)

31 December 2027, for class D devices;

(b)

31 December 2028, for class C devices;

(c)

31 December 2029, for class B devices and for class A devices placed on the market in sterile condition.

3c.

Devices referred to in paragraphs 3a and 3b of this Article may be placed on the market or put into service until the dates referred to in those paragraphs only if the following conditions are met:

(a)

those devices continue to comply with Directive 98/79/EC;

(b)

there are no significant changes in the design and intended purpose;

(c)

the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health;

(d)

no later than 26 May 2025, the manufacturer has put in place a quality management system in accordance with Article 10(8);

(e)

the manufacturer or the authorised representative has lodged a formal application with a notified body in accordance with Section 4.3, first subparagraph, of Annex VII for conformity assessment in respect of a device referred to in paragraph 3a or 3b of this Article or in respect of a device intended to substitute that device, no later than:

(i)

26 May 2025, for devices referred to in paragraph 3a and paragraph 3b, point (a), of this Article;

(ii)

26 May 2026, for devices referred to in paragraph 3b, point (b), of this Article;

(iii)

26 May 2027, for devices referred to in paragraph 3b, point (c), of this Article;

(f)

the notified body and the manufacturer have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII no later than:

(i)

26 September 2025, for devices referred to in paragraph 3a and paragraph 3b, point (a), of this Article;

(ii)

26 September 2026, for devices referred to in paragraph 3b, point (b), of this Article;

(iii)

26 September 2027, for devices referred to in paragraph 3b, point (c), of this Article.

3d.

By way of derogation from paragraph 3 of this Article, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, and to the registration of economic operators and of devices shall apply to devices referred to in paragraphs 3a and 3b of this Article, instead of the corresponding requirements in Directive 98/79/EC.

3e.

Without prejudice to Chapter IV and paragraph 1 of this Article, the notified body that issued the certificate referred to in paragraph 3a of this Article shall continue to be responsible for the appropriate surveillance in respect of the applicable requirements relating to the devices it has certified, unless the manufacturer has agreed with a notified body designated in accordance with Article 38 that the latter shall carry out such surveillance.

No later than 26 September 2025, the notified body that has signed the written agreement referred to in paragraph 3c, point (f), of this Article shall become responsible for the surveillance in respect of the devices covered by the written agreement. Where the written agreement covers a device intended to substitute a device which has a certificate that was issued in accordance with Directive 98/79/EC, the surveillance shall be conducted in respect of the device that is being substituted.

The arrangements for the transfer of the surveillance from the notified body that issued the certificate to the notified body designated in accordance with Article 38 shall be clearly defined in an agreement between the manufacturer and the notified body designated in accordance with Article 38 and, where practicable, the notified body that issued the certificate. The notified body designated in accordance with Article 38 shall not be responsible for conformity assessment activities carried out by the notified body that issued the certificate.

Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022, and 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.

By way of derogation from Directive 98/79/EC, devices which comply with this Regulation may be placed on the market before 26 May 2022.

By way of derogation from Directive 98/79/EC, conformity assessment bodies which comply with this Regulation may be designated and notified prior to 26 May 2022. Notified bodies which are designated and notified in accordance with this Regulation may carry out the conformity assessment procedures laid down in this Regulation and issue certificates in accordance with this Regulation prior to 26 May 2022.

As regards devices subject to the procedures laid down in Article 48(3) and (4), paragraph 5 of this Article applies provided that the necessary appointments to the MDCG and expert panels and of EU reference laboratories have been made.

M4 —————

Authorisations granted by the competent authorities of the Member States in accordance with Article 9(12) of Directive 98/79/EC shall keep the validity indicated in the authorisation.

10.

Until the Commission has designated, pursuant to Article 24(2), issuing entities, GS1, HIBCC and ICCBBA shall be considered to be designated issuing entities.

11.

Article 10a shall also apply to devices referred to in paragraphs 3a and 3b of this Article.

This tool is provided for convenience only and has no legal effect. Only the texts published in the Official Journal of the European Union are authentic. Source: EUR-Lex, CELEX 02017R0746-20250110, © European Union. Reuse is authorised provided the source is acknowledged.

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