Transitional periods for the MDR and IVDR | Health and Youth Care Inspectorate

The regulations on medical devices (MDR) and in vitro diagnostic medical devices (IVDR) impose strict requirements on medical devices and in vitro diagnostic medical devices. The regulations include transitional periods specifying the dates by which manufacturers must comply with the MDR and IVDR.

The transitional periods under the IVDR and MDR have been extended. As a result, economic operators have been given more time to comply with the new requirements and obtain a CE certificate. Notified bodies have also been given more time to certify devices in order to allow them onto the European market. This was not achievable within the previously established deadlines. Without the extension, many medical devices risked disappearing from the European market. Ensuring sufficient availability of medical devices is important for continuity of care and patient safety.

Transitional periods under the MDR

In 2023, Regulation (EU) 2023/607 extending the transitional periods was published. This Regulation extends the transitional periods under the MDR. As a result, CE certificates issued under Directives 90/385/EEC (AIMDD) or 93/42/EEC (MDD) remain valid beyond 26 May 2024. This applies to CE certificates that were valid on the MDR application date, 26 May 2021, and have not been withdrawn by a notified body.

The end date of the transitional periods under Regulation (EU) 2023/607 depends on the risk class of the medical device:

Until 31 December 2027 for class III medical devices and class IIb implantable devices.
Certain medical devices for which the MDR provides exemptions are excluded from this. This is because the legislation considers these medical devices to be based on well-established technologies.
Until 31 December 2028 for devices in the remaining risk classes.
Until 26 May 2026, economic operators may place custom-made class III medical devices on the market without a certificate from a notified body, and end users may put them into service.
Until 31 December 2028, economic operators may place on the market medical devices for which involvement of a notified body was not required under the MDD, but is required under the MDR. End users may also put these devices into service until that date. Please note: this is subject to the condition that the manufacturer drew up a declaration of conformity before 26 May 2021.

The possibility of an extension only applies to certain devices and under the conditions set out in Regulation (EU) 2023/607.

Transitional periods under the IVDR

Transitional periods have been introduced in the IVDR. On 9 July 2024, the European Commission published Regulation (EU) 2024/1860, extending these transitional periods for existing IVDs. The end date of the transitional periods depends on the risk class of the in vitro diagnostic medical device:

Until 31 December 2027 for class D devices;
Until 31 December 2028 for class C devices;
Until 31 December 2029 for class B devices;
Until 31 December 2029 for class A devices placed on the market in sterile condition.

To make use of the transitional periods, manufacturers must comply with a number of conditions. For example, they must have concluded a written agreement for CE certification with a notified body before the applicable deadline. The deadline for this was 26 September 2025 and applied to IVDs that already held a CE certificate under the IVDD and to class D IVDs (the highest risk class, such as HIV tests). In addition, all IVDs must have a quality management system that complies with the requirements of the IVDR.

Key IVDR deadlines by risk class

The manufacturer must have submitted an application to a notified body by no later than:

26 May 2025, for IVDD-certified IVDs*;
26 May 2025, for class D devices (IVDD self-declared);
26 May 2026, for class C devices (IVDD self-declared);
26 May 2027, for class B devices and sterile class A devices (IVDD self-declared).

The manufacturer must have a signed written agreement with a notified body by no later than:

26 September 2025, for IVDD-certified IVDs*;
26 September 2025, for class D devices (IVDD self-declared);
26 September 2026, for class C devices (IVDD self-declared);
26 September 2027, for class B devices and sterile class A devices (IVDD self-declared).

* Provided that the IVDD certificate remains valid in accordance with Article 110 (2) IVDR.

Additional provisions

For IVDs with an IVDD certificate that was valid on 26 May 2022 and expired before 9 July 2024, the extended transitional period only applies if the manufacturer submitted an application and concluded a signed agreement with a notified body before the certificate expired, or if the competent authority permitted or required a conformity assessment pursuant to Article 54 or 92 of the IVDR. For the full transitional provisions, see Article 110 IVDR.