It’s official: regulation of medical devices and in vitro diagnostics (IVD) will undergo significant changes over the next five years. Last week, the EU Parliament approved the proposed changes, disregarding a proposal from the UK Independence Party to reject the new regulations. The new regulations “include stricter premarket review of high-risk devices, strengthened criteria for notified bodies, improved traceability, as well as a risk-based classification system for IVDs… [and are the] result of a multi-year negotiation process between the European Commission, Parliament, and Council to address gaps in oversight that led to several device-related scandals.”1
The new regulations will be published in the Official Journal of the European Union in May. Once published, the new Medical Device Regulations (MDR) will be implemented in three years and the new In Vitro Diagnostics Regulations (IVDR) in five years.
The new medical device and IVD regulations should strengthen transparency of information for consumers, ensuring that vital information is easy to find. For example, patients will receive an implant card containing all essential information; furthermore, a unique device identifier will be mandatory for every product, allowing each product can be found in the new European database of medical devices.2 Elżbieta Bieńkowska, Commissioner for Internal Market, Industry, Entrepreneurship and SMEs at the European Commission, said “I’m extremely happy that our push for stricter controls of medical devices on the EU market will now become a reality. Whether for medical devices, cars, or other products, we must ensure stronger supervision in the interest of our citizens. We should not wait for another scandal instead we should start a discussion how to strengthen European oversight over Member States’ surveillance activities.”2
The regulatory landscape for medical device and in vitro diagnostics will continue to change as products advance and become more connected. Our experts at Pearl Pathways commit themselves each day to driving our clients’ products to market faster. If you have a device or diagnostic in development, contact us today to learn how we accelerate our clients’ product development pathway here in the U.S. market and abroad.