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Please note: New extension of the IVDR

Transitional Periods (Amendment EU 2024/1860)

The regulation (EU) 2024/1860, amending IVDR 2017/746, was published on the 9th of July 2024. A key topic of the amendment is the extension of the IVDR transitional periods. In addition, the European Union has also published a related Q&A document. Please note it is important to read the full text of the amendment and related Q&A document to understand the full implications.
With the new amendment, the dates until which devices certified under the IVDD can be placed on the market or put into service has been extended. The extension time depends on the presence of an IVDD certificate, or in case of self-declared IVDD devices, the IVDR classification of the device.
To be able to make use of the extension, several conditions should be met. The information below will provide an overview of these conditions and the timelines.

Conditions to be met by manufacturer

In order to make use of the extension, the following conditions should be met by the manufacturer:
  • Devices should continue to comply with the requirements of the IVDD.
  • There are no significant changes in design and intended purpose of the device.
  • MDCG 2022-6 provides more guidance as what is regarded as a significant change in this respect.
  • 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.
  • Article 89 and 90 of the IVDR explain the concept of “unacceptable risk to health and safety”.
  • Manufacturer’s QMS shall be in compliance with IVDR article 10(8) before 26 May 2025.
  • Post-Market Surveillance, market surveillance, vigilance and registration of economic operators and devices shall be in compliance with IVDR.
  • An application should be lodged and an agreement signed between the manufacturer (or its authorized representative) and the notified body before a specific date. These specific dates are discussed further below.

Timelines per situation

Situation 1 | With IVDD certificate
Devices with an IVDD certificate (situation 1)
To be able to make use of the extension for a device with an IVDD certificate (Annex II List A, List B and self-tests) the IVDD certificate should:
  • be issued from 25 May 2017;
  • still be valid on 26 May 2022;
  • not have been withdrawn.
If the certificate of the device was still valid on 09 July 2024, and the conditions for the manufacturer are met (see above), the device can be placed on the market or put into service until 31 December 2027
If the device's certificate expired on July 9, 2024, the device can still benefit from the IVDR extension if at least one of the following conditions is met:
The application has been submitted and a written agreement was concluded between the manufacturer and the Notified Body for the device or substitute device, before the expiry of the IVDD certificate.
The competent authority has issued a derogation for the device according IVDR article 54(1).
The competent authority has required the manufacturer in accordance with IVDR Article 92(1), to carry out the applicable conformity assessment.
If the conditions for the manufacturer are met (see above), the device can be placed on the market or put into service until 31 December 2027.
Continuation of supervision
Surveillance of devices with an IVDD certificate must be continued during the transition period.
A manufacturer may change Notified Body when transferring from IVDD to IVDR. Initially, the Notified Body that issued the IVDD certificate will remain responsible for the surveillance of that device, unless the surveillance activities can already be performed by the Notified Body performing the IVDR assessment, when agreed by the manufacturer and incoming IVDR Notified Body. The exact transition could be determined in a tri-partite agreement. However, the notified body performing the IVDR assessment should not become responsible for the surveillance later than 26 September 2025.
Situatie 2 | Without NoBo involvement under IVDD