The European medical technology industry association Eucomed restated yesterday its position regarding the upcoming revision of EU medical technology legislation. The industry agrees that the current decentralised system needs to be adapted and improved.
However, the decentralised approach, which is the essence of the system, should remain as this approach has proven that it allows people to benefit from the latest innovative products while guaranteeing the highest level of patient safety and fostering innovation.
Eucomed believes that individual member states would want to retain control over the health and safety of their citizens, as well as make sure that the innovation and jobs derived from medical technology in their respective country continue to flourish.
Key elements of the current system that need improving include authority control of Notified Bodies, coordination of vigilance and the overall transparency of the system to citizens and other stakeholders. Eucomed is of the opinion that these improvements can all be integrated into the current decentralised system which will also be the most efficient and effective way.
Speaking at Informa’s medical device conference in Brussels, John Brennan, Director Regulatory and Technical Affairs of Eucomed, said: “Our industry recognises the need to adapt and improve medical technology legislation in order to guarantee the best future for patients, society and innovation. But we must be smart, realistic and be able to tell the difference between increasing bureaucracy and increasing patient safety when improving the system.
History and a recent study of Professor Makower show that our current decentralised approach – where member states advise manufacturers on innovation, oversee notified body activities and actively enforce the rules – works.
Let me emphasise that in the current system patient safety is guaranteed, innovative products become available to people faster than anywhere else in the world and innovation flourishes.
Innovation in medical technology usually consists of small and even micro-collaborations between patient groups, clinicians, academia and SMEs which need local support and access to their local authorities in their local language. This is why our industry believes we need to keep and optimise our decentralised approach to product approvals, with enhanced authority control of Notified Bodies.”
Source: Eucomed