After analysing the Commission’s proposal, Eucomed believes the measures are balanced and appropriate and will have a positive effect on patient safety.
Eucomed has called for a legal framework that provides a consistent, EU-wide regulatory approach through improved coordination, evaluation and certification of medical devices; consistent and comprehensive implementation across all EU Member States, as well as efficient vigilance and market surveillance systems.
Europe needs smart regulation that makes efficient and effective use of existing resources and involved structures (European Commission, Competent Authorities, Notified Bodies and industry) so as to retain a simple, adaptable and highly efficient system and merit public confidence.
The European medical devices legislation is currently under revision and Eucomed has suggested six steps to a smarter legal framework for medical devices:
1. Only the best Notified Bodies;
2. One approach to vigilance and market surveillance;
3. Strengthened harmonised standards;
4. Consistent implementation of guidelines;
5. Increased transparency;
6. An integrated approach: better coordination and management.
For more information please visit Eucomed.