The breakdown of the new adopted amendments to IVDR and MDR: Safer Medical Devices in European Union
The European Council has taken significant steps to mitigate shortages of critical medical devices and improve transparency within the healthcare sector. The recently adopted regulation focuses on in-vitro diagnostic medical devices (IVDs) and introduces several key changes:
Extended Transition Period for IVDs:
- In 2017, the EU introduced rules to modernize and enhance safety standards for IVDs.
- The amendment extends the deadline for transitioning to the new system under specific conditions.
- By doing so, it aims to prevent shortages of critical IVDs while maintaining patient safety.
- High-risk IVDs, including certain blood tests, will benefit from this extension.
Gradual Roll-Out of EUDAMED:
- EUDAMED, the European database on medical devices, plays a crucial role in ensuring transparency and accessibility.
- The new regulation enables a gradual roll-out of EUDAMED by requiring manufacturers to provide information about their products to existing modules.
- Manufacturers no longer need to wait for completion of all modules before registering their products.
- This mandatory registration is expected to take effect as of late 2025.
Flagging Supply Interruptions:
- Manufacturers now have an obligation to give prior notice about any interruption of supply for critical medical devices or IVDs.
- Relevant authorities, health institutions, healthcare professionals, and economic operators must be informed promptly.
- This measure aims to prevent sudden shortages and ensure timely responses.
- The regulation will enter into force following publication in the EU’s Official Journal. These changes demonstrate the EU’s commitment to patient safety and efficient healthcare delivery.
Summary
In response to the pressing need for medical device regulation reform, the European Council has enacted a new regulation to prevent shortages and bolster safety. This regulation, which amends the 2017 legislation on in-vitro diagnostic medical devices (IVDs), introduces three pivotal changes: an extension of the transition period for IVD compliance to avert market withdrawal risks, a phased implementation of the European database on medical devices (EUDAMED) to enhance transparency, and a requirement for manufacturers to notify of potential supply interruptions of critical IVDs. Set to be enforced following its publication in the EU’s Official Journal, this regulation is a strategic move to modernize medical device regulations and ensure patient safety, with a particular focus on high-risk IVDs. The regulation adopted by the council will enter into force following publication in the EU’s Official Journal.
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Published on: June 6, 2024
