The medical technology industry is an important economic and social player in Europe. The challenge is to provide companies and users in this sector access to affordable and advanced testing facilities and services to facilitate the development of new and safe medical technologies. The two new EU regulations governing medical technologies (medical devices and in-vitro diagnostics) are introducing a new set of rules to improve the safety of medical devices for the benefit of patients. To preserve timely access to innovative healthcare solutions and support the competitiveness of the European industry, testing facilities support services are needed to help industry and users develop and test medical devices in compliance with EU safety regulations. A bonus would be to define new methodologies for clinical testing, when relevant.Scope:
Proposals submitted under this topic should include actions designed to facilitate cooperation, across Europe, with other projects; to enhance user involvement; and to ensure the accessibility and reusability of data produced in the course of the project.
Activities should start at TRL 4 and achieve TRL 7 at the end of the project.
The Commission considers that proposals requesting a contribution from the EU between EUR 7 and 15 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.Expected Impact:
Relevant indicators and metrics, with baseline values, should be clearly stated in the proposal.Cross-cutting Priorities:
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU