The European Parliament has adopted new measures, initially proposed by the Commission in January 2024, to improve the availability of in vitro diagnostics (IVDs), launch of parts of the European database on medical devices, Eudamed, and a mandatory prior notice in case disruption of supply is anticipated:
- Extended Transition Period: Companies are given additional time to adapt to new EU regulations on IVDs.
- Phased Implementation of Eudamed: Supports the gradual roll-out of the European Database on Medical Devices (Eudamed) to improve market transparency. Additionally, the adoption of these measures facilitates the upcoming mandatory use of several components of Eudamed starting in early 2026, aiming to boost transparency and provide a comprehensive view of medical devices in the EU.
- Mandatory notification of discontinuation: Manufacturers must inform authorities and healthcare sectors about any disruptions in the supply of medical devices. A 6-month advance notice to competent authorities, distributors, and healthcare providers must be provided if Manufacturers anticipate any disruptions in the supply of certain IVDs or medical devices, ensuring time to safeguard patient care.
The next steps involve the Council’s formal adoption of the amendment, after which the Regulation will become effective upon its publication in the Official Journal of the European Union. The Commission plans to collaborate with Member States and stakeholders to ensure the effective implementation of this legislation.
Here you can find the official press release.