Europe: Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation

ARQon
Jan 11, 2022
2 min read

The IVDR was officially published on 5 May 2017 and entered into force on 26 May 2017. The initial implementation date of IVDR was planned on 26 May 2022, where manufacturers of currently approved medical devices will have a transition time of five years. However, there is a serious shortage of notified body capacity, making it impossible for manufacturers to conduct the legally required conformity assessment procedures in time.

After the EU Parliament, the EU Council has approved the IVDR transitional measures. The new proposal is now fully approved. The amending Regulation does not change any requirements of the original In Vitro Diagnostic (IVD) Regulation of 2017.

The new dates to comply with IVDR are:

For higher risk devices, such as HIV or hepatitis tests (class D), the new requirements will apply as 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.
For lower risk class devices (class B and A sterile), the application starts in May 2027.
The application of certain requirements for devices manufactured and used in the same health institution (so-called ‘in-house devices') is delayed by two years until May 2024. If, however, the health institutions prove the unavailability of an equivalent device on the market, the transitional periods will end in May 2028.
No change is proposed for CE-marked devices that do not require notified body involvement under the IVD Regulation, or for devices that are ‘new', i.e. devices that have neither a notified body certificate nor a declaration of conformity under the current Directive 98/79/EC. For those types of devices, the IVD Regulation will therefore apply from 26 May 2022 as planned.