In Vitro Diagnostic Regulation (IVDR)

The IVDR replaced the IVDD and entered into force on 26 May 2017. By 26 May 2022 all new IVDs placed on the market and Class A non-sterile had to comply with the IVDR. All IVDD CE certified devices must comply to the IVDR by 26 May 2025 or upon certificate expiry. Depending on the risk class, the transition period for IVDD self-declared devices is the 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. IVDD certified devices can no longer be placed on the market or put into service.

For self-certified IVDs already placed on the market under the IVDD, a sell-off period of one year is granted after Class D, C, B and A sterile compliance deadlines.

The major areas of change in the IVDR include:

• Rule-based classification system
• Requirements for clinical evidence and post-market clinical 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.