The new rules aim to ensure that patients, consumers and healthcare professionals can reap the benefits of safe, effective and innovative medical devices. According to the European Commission, the main aim of the revised proposal is ’safer, more effective and innovative medical devices.’

What does the European Commission propose?

  • Wider and clearer scope of EU legislation.
  • Stronger supervision of independent assessment bodies by national authorities.
  • Clearer rights and responsibilities for manufacturers.
  • Better traceability of devices throughout the supply chain.

Who will benefit?

  • Patients and consumers
  • Healthcare professionals
  • Manufacturers

New regulatory framework

The revised regulatory framework for medical devices is comprised of a proposal for regulation on medical devices. It will replace two directives; the Directive 90/385/EEC regarding active implantable medical devices, and Directive 93/42/EEC regarding medical devices. The new regulatory framework also introduces a proposal for the Regulation of in vitro diagnostic medical devices (in this case, to replace Directive 98/79/EC regarding in vitro diagnostic medical devices).

Next steps?

The Commission proposals will be discussed in the European Parliament and in the Council. The proposals are expected to be adopted in 2014 and would then gradually come into effect from 2015 to 2019.

For further information.

EPHA-related articles:
- EPHA Briefing on Medical Devices Directive
- Medical devices: health ministers have their say
- Commission launches revision of the Medical Device Directives
- European Commission proposes mandatory use of medical devices database

Last modified on September 29 2012.