The European medical technology industry recognises the need to improve the
effectiveness of the current European regulatory framework for medical devices.
Eucomed, the European industry association for medical technology, appreciates
the European Commission’s swift reaction and clear proposal for a joint plan of immediate
measures to strengthen the European medical devices
legislation. 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:
- Only the best Notified Bodies;
- One approach to vigilance and market surveillance;
- Strengthened harmonised standards;
- Consistent implementation of guidelines;
- Increased transparency;
- An integrated approach: better coordination and management.
For more information download the following documents:
- Eucomed position paper: A new EU regulatory framework for medical devices
- Eucomed statement on PIP breast implant incidents
- Eucomed blog posting on how the EU regulatory framework should change because of the PIP incidents
About Eucomed
Eucomed is the European medical technology industry association. Its
mission is to make modern, innovative and reliable medical technology available
to more people. Eucomed represents directly and indirectly 22,500 designers,
manufacturers and suppliers of medical technology used in the diagnosis,
prevention, treatment and amelioration of disease and disability. Small and
medium sized companies make up more than 80% of this sector. The European
medical technology industry generates annual sales of €95 billion, invests some
€7.5 billion in R&D and employs around 500,000 highly skilled workers. For
more information visit www.eucomed.org and www.reforminghealthcare.eu