In Vitro Diagnostic Regulation

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.

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.

BSI The Netherlands is a leading EU Notified Body; we review Technical Documentation as part of a conformity assessment to ensure that medical devices meet the necessary safety and performance requirements to allow them to be placed on the market.

The BSI team has a unique set of expertise from our product and regulatory experience that allows us to provide a rigorous review of your Technical Documentation. This gives confidence in your certification to you and your key stakeholders.

BSI offers Technical Documentation review; you will be assigned a dedicated Scheme Manager to work with you throughout your product certification journey and will remain your point of contact thereafter.

Sign up to receive further information about how BSI can support IVD device manufacturers wishing to certify to the IVDR.