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In Vitro Diagnostic Regulation (IVDR)

The In Vitro Diagnostic Regulation (IVDR) replaced the IVDD and entered into force on 26 May 2017 with 26 May 2022 as date of application

In 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 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).

European Union

In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746

BSI the Netherlands is a leading Notified Body (2797) achieving full-scope designation under IVDR. We are also a full-scope UK Approved Body (0086) assessing medical IVDs against UK legislation. We review your medical 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 device to the market.

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

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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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Whether you're starting the certification process, looking to transfer or just need to discuss options for your business, we can help.

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