EU Council Adopts New Measures to Prevent Medical Device Shortages

The European Union is taking proactive steps to prevent potential shortages of medical devices, particularly in-vitro diagnostic devices (IVDs), which are crucial for various medical diagnoses, including HIV, cancer, pregnancy, and COVID-19. On May 30, 2024, the EU Council adopted several measures aimed at addressing this issue by extending the transition period for certain high-risk IVDs and speeding up the registration process in the EUDAMED database.

Background and Importance

The updates to the legislation come as part of the EU’s broader strategy to modernize and enhance the regulatory framework for medical devices and in-vitro diagnostics. Initially introduced in 2017, the new rules aimed to guarantee the safety and effectiveness of medical devices. However, the transition to these new regulations has been challenging, leading to concerns about the availability of critical IVDs.

In 2017, the EU implemented new rules to modernize the framework for medical devices and in-vitro diagnostics. These rules significantly increased the demand for scientific and regulatory expertise, which has taken time to develop. As a result, many critical IVDs are not yet compliant with the new standards, posing a risk of market shortages once the initial transition deadline passes.

The recent measures are part of a compromise agreement that will be formally adopted by the European Parliament and the Council after a legal-linguistic review. These steps are seen as essential to maintain the availability of vital medical devices and ensure that healthcare providers have the necessary tools to deliver high-quality care.

Key Measures

Extended Transition Period

The Council has decided to extend the transition period for high-risk IVDs. This extension is critical to ensure that these devices remain available on the market while manufacturers work towards compliance with the new requirements introduced by Regulation (EU) 2017/746 on IVDs. The transition period will now extend until the end of 2027, giving manufacturers more time to meet the necessary scientific, technical, and regulatory requirements.

Mandatory EUDAMED Registration

To improve industry transparency and traceability, the new measures require manufacturers to register their devices in the Eudamed database by late 2025. Eudamed, the European database on medical devices, is designed to provide comprehensive data on all medical devices available in the EU market. Although initially planned for a phased rollout, manufacturers are now mandated to use the available modules for registration, expediting the process.

Supply Interruption Notifications

In what comes as a significant update to Article 10, manufacturers will now be obligated to notify relevant authorities, health institutions, and economic operators of any potential supply interruptions of critical medical devices. This early warning system is intended to mitigate the impact of shortages on healthcare systems and ensure that alternative arrangements can be made in a timely manner.

For more details, you can read the full article on the Council of the European Union’s website here.

The amending text can be found directly at the following link.

How we can help

For more information on how these new measures may impact your business and to ensure compliance with the updated regulations, contact us at info@specculo.com. Stay ahead of the regulatory curve and safeguard your medical device supply chain.