In Vitro Diagnostic Regulation (IVDR)

In Vitro Diagnostic Regulation (IVDR)

The Date of Application of the IVDR is May 2022 to update technical documentation to meet the new requirements.

The Date of Application of the IVDR is May 2022 to update technical documentation to meet the new requirements.
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In Vitro Diagnostic Regulation

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.

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.

*Please note, for the IVDR timeline, these changes can be considered effective only once published on the Official Journal.

Download the IVDR timeline

BSI issues its first certificate to the In Vitro Diagnostic Devices Regulation

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MedTech Summit 2020 | Initial experiences of applications under the IVDR – A Notified Body's View

Why is this change so significant for IVD medical device manufacturers?

The new Regulation brings with it significant changes to the regulatory requirements for IVD medical device manufacturers and introduces a new rule-based classification system with increased Notified Body involvement. The new rule-based system supersedes the current list-based approach in the Directive. This change means that, as classification rules will be applied to all IVD medical devices, up to 90% of IVD medical devices will require a notified body for conformity assessment.

In addition to the change in classification rules, there is also increased harmony between the IVDR and the Medical Device Regulation (MDR), the equivalent for medical devices, including a focus on clinical evaluation and increased transparency through the wider supply chain.

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