Manufacturer’s Declaration - Transitional Provisions IVDR (EU) 2024/1860

Aug 31, 2026

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Manufacturer’s Declaration addresses transitional provisions under Regulation (EU) 2024/1860 amending Regulation (EU) 2017/746 (IVDR) for specific in vitro diagnostic medical devices. It covers extended transitional periods when IVDD conformity assessment procedures did not require a notified body, where a notified body becomes required under IVDR, and the validity of Directive 98/79/EC certificates. The declaration confirms continued placing on the market and putting into service through selectable statements on applications, agreements, expiry conditions, derogations or requirements, and Quality Management System (QMS) status.

LanguageEnglish

CategoryForms

FormatDOCX

Pages5

Reading Time2 min

AccessFree to download

Manufacturer’s Declaration

Transitional provisions under (EU) 2024/1860

Conditions for legal extension under Article 110

Notified body involvement and applicable statements

Directive certificate validity and expiry conditions

Derogations or conformity assessment requirements

Quality Management System (QMS) statements

Continued placing on the market and putting into service

Manufacturer’s Declaration in relation to Regulation (EU) 2024/1860 amending Regulation (EU) 2017/746 (IVDR) as regards the transitional provisions for certain in vitro diagnostic medical devices, in particular with respect to the extended transitional periods for devices for which the conformity assessment procedure pursuant to Directive 98/79/EC (IVDD) did not require the involvement of a notified body, for which the declaration of conformity was drawn up prior to 26 May 2022 and for which the conformity assessment procedure pursuant to Regulation (EU) 2017/746 (IVDR) requires the involvement of a notified body and/or the validity of certificates issued under Directive 98/79/EC (IVDD) (Directive Certificate) and/or the compliance of the devices and us, as their manufacturer, with the conditions for the continued placing on the market and putting into service We, as the manufacturer declare under our sole responsibility: for the device(s) listed in the attached schedule the conditions for the legal extension of transitional periods as required in Article 110.3b of the IVDR are met and/or for the Directive Certificate(s) listed in the attached schedule the conditions for the legal extension of validity as required in Article 110.2 of the IVDR are met and/or the device(s) listed in the attached schedule and we as their manufacturer are in compliance with the conditions listed in Article 110.3c of the IVDR for continued placing on the market and putting into service, namely by fulfilling the following conditions: Devices which were self-declared under the IVDD and require notified body involvement under the IVDR In case of devices for which the conformity assessment procedure pursuant to IVDD did not require the involvement of a notified body, for which the declaration of conformity was drawn up prior to 26 May 2022 and for which the conformity assessment procedure pursuant to IVDR requires the involvement of a notified body: Choose one applicable statement: ☐ Formal application(s) to the notified body in accordance with Section 4.3, first subparagraph of Annex VII IVDR for conformity assessment has/have been lodged or will be lodged by us to a notified body for the device(s) listed in the attached schedule or its/their substitutes no later than: ☐ 26 May 2025 for class D devices ☐ 26 May 2026 for class C devices ☐ 27 May 2027 for class B and class A (sterile) devices ☐ Signed written agreement(s) is/will be in place in accordance with Section 4.3, second subparagraph of Annex VII IVDR for the device(s) listed in the attached schedule or its/their substitutes no later than: ☐ 26 September 2025 for class D devices ☐ 26 September 2026 for class C devices ☐ 27 September 2027 for class B and class A (sterile) devices ☐ We do not intend to lodge an application for conformity for the device as indicated on the attached schedule. Directive Certificate(s) as listed above or in the attached schedule Directive Certificate(s) covering the device(s) listed in the attached schedule was/were issued after 25 May 2017, was/were valid on 26 May 2022 and has/have not been withdrawn afterwards. Choose applicable statements: ☐ Original expiry date before 9 July 2024: ☐ Before the original date of expiry as indicated on the Directive Certificate(s), we and the notified body have signed written agreement(s) in accordance with Section 4.3, second subparagraph of Annex VII IVDR for the conformity assessment(s) in respect of the device(s) covered by the expired certificate(s) or in respect of its/their substitute(s), or ☐ Competent Authority has granted a derogation from the applicable conformity assessment procedure in accordance with Article 54(1) IVDR (may be provided upon request), or ☐ Competent Authority has required us as the manufacturer, in accordance with Article 92(1) IVDR, to carry out the applicable conformity assessment procedure (may be provided upon request) Choose one of the following statements only if a

FAQs

What legal basis does this Manufacturer’s Declaration reference for transitional provisions?

It references Regulation (EU) 2024/1860 amending Regulation (EU) 2017/746 (IVDR), including transitional provisions connected to earlier IVDD requirements and certificate validity under Directive 98/79/EC (IVDD).

Which situations can the declaration cover regarding notified body involvement and conformity assessment?

It covers devices where IVDD did not require a notified body but IVDR requires notified body involvement, and it also addresses extension conditions related to certificates issued under IVDD and compliance for continued market placement and service.

What does the declaration require the manufacturer to confirm about the Quality Management System (QMS)?

It provides selectable statements confirming whether the QMS is in place or will be implemented by specified deadlines, and whether the notified body has issued a certificate for an IVDR-compliant QMS.

Aug 31, 2026

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