Edition of 16 November 2021

The European Commission has proposed a progressive roll-out of the new in Vitro Diagnostic Medical Devices Regulation (IVD Regulation), which was planned to apply as from 26 May 2022. The aim of this regulation to secure quality of all kinds of medical diagnostic tests, and to make sure such tests are performed within the frame of the health care system. This roll-out proposal aims at preventing disruption in the supply of in vitro diagnostic medical devices on the market, as shortage of notified body capacity make it impossible for manufacturers to conducted the required conformity assessment in time. The Commission recalls that Article 110 of the IVD Regulation provides for a transitional period until 26 May 2024 for in vitro diagnostic medical devices with a certificate issued by a notified body in accordance with the Directive on in vitro diagnostic medical devices prior to 26 May 2022. This transition period is extended by 1 year until May 2025. However, only devices that require a notified body certificate already under this Directive will benefit from this existing transitional provision, the general application date of the Regulation remaining 26 May 2022 for all other devices.

The Commission has also proposed a deferred application of the requirements for devices manufactured and used within the same health institution (‘in-house devices'). On this matter, the European Society of Human Genetics had called for the removal of Article 5-§5 conditions (d)-(i) for in-house exemptions from the IVD Regulation back in 22 September 2020. The ESHG invoked the need for flexibility and innovation for personalised laboratory tests, especially for rare conditions, as well as the risk of increased health care costs under the new conditions. This new timeframe for the implementation of the regulation could therefore benefit the rare disease community.