Get ready for the in-vitro diagnostics regulations

The 26th May 2022 is the date of the introduction of the In-Vitro Diagnostic Regulations IVDR (EU 2017/746). What will the new rules mean?

The IVDR is replacing the EU In-Vitro Diagnostics Directive (IVDD) 98/79/EC, and the technical documentation needs to updated to meet the new requirements. This new regulation is more stringent and introduces a new rule-based classification system with increased notified body requirement. This means that up to 90% of in vitro diagnostic devices will need notified body involvement, with class A non-sterile devices being the only exemption. 

Furthermore,, there will be a greater requirement for clinical studies to provide evidence for performance and safety. Although the In-Vitro Diagnostics Regulations (2017/746) still come into effect from 26th May 2022, due to a shortage of notified body capacity the European Commission have acknowledged that there is a risk of disruption in the supply of in-vitro diagnostic devices. As a result, the commission decided that to roll out the transition period based on the risk classification of the device with higher risk devices, such as HIV or hepatitis tests (class D), the new requirements will apply from May 2025. For devices of the lower risk class C, such as certain influenza tests, the date of application is extended until May 2026, whilst for lower risk class devices (class B and A sterile), the application starts in May 2027.

The devices that were on the market prior to 26th May 2022 and did not require a notified body, for which a declaration of conformity was drawn up prior to 26th May, may be placed on the market in accordance with the dates outline above. The changes do not impact devices that do not require notified body certification under the IVDR. Importantly, there is no extension provided for IVDs that are ‘new’ to the market (they have not been certified or declared for conformity under the IVDD).

If you need regulatory advice and support, please contact [email protected].