EU Member States Stress Importance of Medtech Innovation for Maintaining Sustainable Healthcare Systems
June 6, 2011 – 9:10 amThe Council of the European Union has emphasised the importance of medtech innovation in improving health outcomes and the sustainability of European healthcare systems, writes Eucomed in a press release issued today. European Member States also reaffirmed their support of the current legal framework, recommending focused attention to essential amendments to the current system rather than wholesale changes.
The Council Conclusions send a clear political mandate to the European Commission to fully integrate medical technology innovation into EU policies and initiatives, writes Eucomed. The conclusions call upon member states and the Commission to take initiatives promoting innovation of medical technology that improve cost-effectiveness and focus on health priorities and healthcare needs.
The conclusions include a list of considerations that the Commission is invited to bear in mind as it reviews the three directives on medical devices:
- A system that is sustainable and ensures safety and promotes innovation;
- The recognition of the difference between CE marking and health technology assessment in terms of the order in which they happen and the role and sources of clinical evidence;
- Improved notified bodies;
- Coordinated and coherent vigilance;
- Development of a modern IT structure and, in particular, a central database accessible to the public;
- The need for increased transparency.
Read the full press release of the Council of the European Union: Council Conclusions on innovation in the medical device sector.
Tags: Council of the European Union, EU medical technology innovation, EU medtech regulatory framework, medical device directives
