The commission has issued today two regulation proposals with the intention to replace existing- and apparently obsolete- directives :
- A proposal for a Regulation on medical devices (to replace: Directive 90/385/EEC regarding active implantable medical devices and Directive 93/42/EEC regarding medical devices);
- A proposal for a Regulation on in vitro diagnostic medical devices (to replace Directive 98/79/EC regarding in vitro diagnostic medical devices).
The objective is to enlarge and clarify the scope of EU legislation, improve the functioning of assessment bodies, achieve more transparency and match the regulation to the current state of science while revising manufacturers' rights and duties. The commission also seeks to foster international trade by "alignment to international guidelines".
Health and Consumer Policy Commissioner John Dalli said "Just a few months ago, everybody was shocked by the scandal involving fraudulent breast implants which affected tens of thousands of women in Europe and around the world. As policy makers, we must do our best never to let this happen again. This damaged the confidence of patients, consumers and healthcare professionals in the safety of the devices on which they rely every day. The proposals adopted today significantly tighten the controls so as to ensure that only safe devices are placed on the European Union's market at the same time, they foster innovation and contribute to maintaining the competitiveness of the medical device sector."
If you are curious to know more about how the regulations should fulfill this daunting functions, please have a look here and here.