In Vitro Diagnostic Regulation

By May 26 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 May 26 2025 or upon certificate expiry. Depending on the risk class, the transition period for IVDD self-declared devices is May 26 2025 for Class D devices and extends to May 26 2026 for Class C devices and to May 26 2027 for Class B and A sterile devices. On May 27 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.

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.