In Vitro Diagnostic Regulation

The IVDR replaced the IVDD and entered into force on 26 May 2017 with 26 May 2022 as date of application. On March 2023, the IVDR was amended as regards to transitional provisions for certain in vitro diagnostic (IVD) medical devices on Article 110(4) with the removal of the sell-off period to prevent unnecessary disposal of safe in vitro diagnostic medical devices that are still in the supply chain by means of (EU) 2023/607. On 9 July 2024 (EU) 2024/1860 has been published in the Official Journal of the European Commission and amends and further extends the transitional periods laid down in the IVD Regulation.

Only legacy devices, meaning devices covered by a certificate issued by 26th May 2022 or declaration of conformity drawn up before 26 May 2022 under the IVD Directive, and considered valid by virtue of Article 110 3a and 3b, may benefit from the extended transition period if:

  • The device continues to comply with IVDD requirements.
  • There are no significant changes in design or intended purpose or the device.
  • The device does not present an unacceptable risk to the health and safety of patient.
  • The manufacturer has implemented an IVDR compliant QMS no later than 25 May 2025
  • Depending on the risk class of the device, the manufacturer has lodged a formal application with a NB by May 2025 for IVDD certified devices and Class D devices that were self-declared under the IVDD, by May 2026 for Class C self-declared IVDs and by May 2027 for class B and A-Sterile self-declared IVDs.
  • Depending on the risk class of the device, the manufacturer has signed a written agreement with a NB by September 2025 for IVDD certified devices and Class D devices that were self-declared under the IVDD, by September 2026 for Class C self-declared IVDs and by September 2027 for class B and A-Sterile self-declared IVDs.

If the above requirements are fulfilled, depending on the risk class of the device, the transition period is extended to:

  • 31 December 2027 for IVDD certified devices and Class D self-declared devices .
  • 31 December 2028 for Class C self-declared devices.
  • 31 December 2029 for Class B and A-Sterile self-declared devices.

IVDR Class D Requirements in the Absence of EU Reference Laboratories

IVDR QMS deadline 2023

Time for your IVDR application is now

"If you do not have an agreement with a Notified Body reach out today and if your technical documentation is ready, there is really no reason to delay your IVDR application".

Elizabeth (Liz) Harrison, Global Head of IVD at BSI.

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What is the IVDR?

By 26 May 2022 all new IVDs placed on the market and Class A non-sterile devices had to comply with the IVDR. All IVDD CE certified devices must comply with the IVDR by 26 May 2025 or upon certificate expiry. Depending on the risk class, the transition period for IVDD self-declared devices is 26 May 2025 for Class D devices and extends to 26 May 2026 for Class C devices and to 26 May 2027 for Class B and A sterile devices. On 27 May 2027, all devices must comply with IVDR.

The sell-off period for self-certified IVDs already placed on the market under the IVDD has been removed. These devices can be made further available on the market without legal time restrictions. For in-house devices, the requirement to justify that an equivalent device is not available on the market is postponed until May 2028.

Key changes of the IVDR

The major areas of change in the IVDR include:

  • Rule-based classification system
  • Requirements for clinical evidence and post-market performance follow-up
  • Increased traceability of devices (UDI)

As a manufacturer of in-vitro diagnostic devices, you must ensure that you meet the relevant regulatory requirements before placing your product onto the market.

European Union

In Vitro Diagnostic Regulation (IVDR) 2017/746

Further Industry and Regulatory Guidance is also available.

BSI The Netherlands is a Notified Body (2797) achieving full-scope designation under IVDR and MDR. We are also a full-scope UK Approved Body (0086) assessing medical devices against UK legislation. We review your IVD device to ensure conformity against the relevant Regulations by offering a range of flexible product review services providing you with efficient pathways to bring your product to the market.

For more information visit our CE marking and UKCA marking dedicated webpages.

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IVDR documentation submission

Download our IVDR best practices guidelines to help you prepare and structure your Technical Documentation when planning your IVDR conformity assessment application to BSI.

Download the document
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IVDR conformity assessment routes

Our guiding brochure will support you in understanding conformity assessment routes and in selecting the most suitable for your in-vitro diagnostic device.

Download the brochure