Brussels (Brussels Morning) – The European Commission applauds the European Parliament’s adoption of measures to improve access to in vitro diagnostics (IVDs), providing more time for compliance and enhancing transparency in medical device supply chains.
The European Commission has welcomed the adoption by the European Parliament of steps, proposed by the EU Commission in January 2024, to enhance the availability of in vitro diagnostics (IVDs) for patients and healthcare providers.Â
What Steps Did the EU Commission Propose for Medical Devices?
These steps include granting more period to companies to transition to the latest EU rules on IVDs, presenting a new obligation on manufacturers to notify national authorities and the health sector of the possibility of disturbance of supply of certain medical devices and permitting the gradual roll-out of the European Database on Medical Devices – Eudamed. The steps give more time to consider likely actions to safeguard patient care in illustrations where certain devices are paused and increase transparency concerning medical devices on the market.
EU Commission states that the accessibility of IVDs, such as HIV or hepatitis tests, is important for patients. A considerable number of IVDs presently on the market do not yet agree with the EU rules which have been functional since May 2022. Matter of certain conditions, the new laws give more time for manufacturers to transition to the latest requirements without compromising protection and mitigate the risk of shortages.
What Impact Will Extended Transition Periods Have?
The extra time given to companies relies on the type of device: high individual and public health risk devices such as HIV or hepatitis tests (class D) will have a growth period until December 2027; high individual and/or moderate public health threat devices such as cancer tests (class C) will have an evolution period until December 2028; more down risk devices (class B) such as pregnancy tests and (class A) sanitary devices such as blood collection tubes have a transition period until December 2029.
What Are Manufacturers’ New Obligations Regarding Supply?
Manufacturers are also demanded to give prior notice if they anticipate trouble in the supply of specific IVDs or medical devices. They must deliver this information 6 months in advance to qualified authorities, as well as distributors and healthcare providers. This will permit them enough time to bring action to guarantee patient care.
Moreover, the Commission contended that today’s agreement by the Parliament will also promote the launch of parts of the EU database on medical devices, Eudamed. From the start of 2026, the use of several elements of Eudamed will become mandatory. This will improve transparency in the EU and deliver an overview of medical devices unrestricted on the European market.
What Are the Next Steps for Implementing These Measures?
In the Next steps, the European Council will now formally assume the amending Regulation. The Commission stresses that it will work together with Member States and all stakeholders to deliver the necessary support to execute this legislative amendment. This will include defining in which cases manufacturers must report of a disruption of supply.
