Position paper on a new EU regulatory framework for medical devices

To face the grand challenges in health such as healthy ageing, constrained health budgets, fewer carers and fewer tax-payers, Europe will need to look at shaping new models of healthcare delivery. Ensuring quality and financial sustainability should be key features of the model. In this context the European Commission and national governments will need to deliver policies which promote the necessary innovation and changes in healthcare systems. Value-based innovationiii in medical devices and services, which marries cost-efficiency with improved health outcomes, is an essential part of the solution to public health challenges as well as to the broader challenges to Europe‟s competitiveness.

Eucomed, the European medical technology industry association, recognises the need to modernise and strengthen the current medical devices legislation in Europe, in particular, by coupling more enhanced Member State engagement with better European science-based coordination and management of the regulatory system. The objective should be to achieve a smart and efficient legislative framework that is consistently implemented across the EU and guarantees patient safety, high quality and rapid access to the latest medical technologies. This legislative framework should at the same time encourage research and innovation and reduce administrative burden, in particular for SMEs, which are the backbone of the medical technology sector.