The European Commission has just proposed two fresh regulations which seem to be fit for purpose, more transparent and better adapted to scientific and technological progress.
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?
Who will benefit?
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).
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 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