On Tuesday 23 January, the European Commission proposed giving companies more time to implement the regulation on in vitro diagnostic medical devices, subject to certain conditions.
The latest available data shows that a large number of in vitro diagnostic medical devices currently on the market have not been taken into account in the new rules, which means that these devices would no longer be available. The number of devices that have not taken the new rules into account is very high for high-risk in vitro diagnostic medical devices (class D). These include important tests for detecting infections in blood transfusions or organ donations.
The Commission is therefore proposing to extend the transition periods in order to give manufacturers and notified bodies more time to complete the necessary conformity assessment procedures. This extension will be subject to conditions and will therefore preserve the high level of requirements set by the legislation and protect public health.
It also proposes measures to enable and accelerate the gradual roll-out of EUDAMED, a database that will contain information on all medical devices and in vitro diagnostic medical devices placed on the EU market. The compulsory use of finalised parts of EUDAMED will help all the key players to implement the regulatory framework and increase transparency for the public.
The proposal introduces an obligation for manufacturers to give prior notification to authorities, as well as to distributors or healthcare establishments, if they plan to discontinue the supply of in vitro diagnostic medical devices or medical devices, which would present risks to patient care. This measure would give healthcare systems more time to take actions to protect patient care.
Link to the proposal: https://aeur.eu/f/aiv (Original version in French by Lionel Changeur)