What is the story about?
What's Happening?
MedTech Europe, representing the medical device and diagnostic industries, is pressing the European Commission to implement regulatory changes by early 2026. The trade group, along with 35 national associations, is calling for immediate relief measures, including a delay in re-certification requirements for devices under current medical technology regulations. This request aims to prevent a bottleneck that could disrupt the market. MedTech Europe also advocates for longer-term reforms, such as establishing a governance structure for notified bodies and harmonizing rules to streamline the regulatory process.
Why It's Important?
The call for regulatory reform is crucial for the medical device industry, which faces challenges under the current EU regulations. Delays in re-certification could lead to product shortages, affecting healthcare providers and patients. By advocating for changes, MedTech Europe seeks to ensure that the regulatory environment supports innovation and competitiveness. The proposed reforms could enhance the efficiency of the CE-marking system, making it more globally competitive and ensuring the availability of medical devices in the EU market.
What's Next?
The European Commission is expected to consider MedTech Europe's proposals as part of its ongoing review of medical device regulations. If adopted, the reforms could lead to a more streamlined regulatory process, benefiting manufacturers and healthcare providers. The industry will likely continue to engage with EU authorities to advocate for changes that support innovation and market access. The outcome of these discussions could shape the future regulatory landscape for medical devices in the EU.
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