A consortium of medical technology companies in the European Union (EU) has published a document outlining its vision for the future of the EU’s medical technology regulations.
In its position paper, titled “The Future of Europe’s Medical Technology Regulations,” MedTech Europe calls for “a comprehensive reform” in current regulations applicable to medical devices in the EU to help expedite the review and approval of medical devices. Specifically, the position paper calls for reform in three key areas as follows:
- An efficient CE marking system that reduces administrative burdens, improves predictability, and is adaptive to external changes and developments;
- A system that works for innovation by streamlining the pathways for regulatory review and approval of the latest and most advanced medical technologies; and
- An accountable governance structure to oversee and manage the regulatory system, including the designation and oversight of EU Notified Bodies.
MedTech says that reforming the current regulatory approach would enable device manufacturers to bring new medical device technologies sooner, thereby benefiting both patients and healthcare systems and providers.