EU adopts progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation (IVDR)

Amendments adopted to transitional provisions to give more time for conformity assessments

The In Vitro Diagnostic Medical Devices Regulation (IVDR) was adopted in 2017. The date of application of the IVDR was originally scheduled as 26 May 2022. The European Council and Parliament have now adopted an amendment to the IVDR that changes the date of application for certain classes of in vitro diagnostic medical devices. The amending Regulation does not change any requirements contained in the original IVDR, only the dates from which some of those requirements apply.

The IVDR introduces substantial changes in the regulatory framework for in vitro diagnostic medical devices. In particular, the classification system changes so that many more devices will require the involvement of notified bodies in the process of conformity assessment. However, there have been delays in developing the infrastructure to support the implementation of the regulation, including the designation of notified bodies to undertake the assessment of conformity.

There is no change for CE-marked devices that do not require notified body involvement under the IVDR, or for new devices that do not have either a notified body certificate or a declaration of conformity under the IVD Directive. For these types of devices, the IVDR applies from 26 May 2022 as planned.

For other devices, there are staggered arrangements quite similar to that introduced for legacy devices under the European Medical Devices Regulation (MDR).  Devices that were lawfully placed on the market under the IVD Directive before 26 May 2022 can continue to be made available or put into service until 26 May 2025. IVDs that were self-certified or self-test under the IVD Directives but require certificates from a notified body under the IVDR will have the date of application changed to later years. The additional time increases as the risk associated with the devices decreases, as follow:

• 26 May 2025 for Class D
• 26 May 2026 for Class C
• 26 May 2027 for Class B and Class A, sterile.

It is important to note that the IVDR requirements regarding post-market surveillance (PMS), market surveillance, vigilance and registration of economic operators apply for these devices from the original date of application, i.e., 26 May 2022.

In addition, application of certain requirements for in-house devices that are manufactured and used in the same health institution is delayed by two years until May 2024. However, if the health institutions can show that an equivalent device is not available on the market, the transitional periods will end in May 2028.

Manufacturers should not see this delay in implementation for certain classes of device as a reason to relax their implementation plans. Although there is additional time, notified bodies will continue to be very busy and there will be new demand peaks associated with these revised implementation dates. New or significantly changed devices will still need to need to comply with the IVDR straight away. Furthermore, the IVDR requirements for PMS, vigilance and registration of economic operators apply from 26 May 2022, and these systems need to be in place.