Brussels, 23/05/2005 (Agence Europe) - Medical technologies, like pharmaceuticals, are evolving constantly. Medical devices- which include screening or diagnostics systems, drug administration appliances, dialysis machines or breast implants- are increasing in number and dependent on numerous cutting-edge technologies. This means that the Commission must update European rules on medical devices. It has decided to submit its proposal on medical devices and on active implantable medical devices to public consultation.
The changes proposed aim to improve: 1) clinical evaluation, through clarification of the requirements; 2) post market surveillance, with a view to increasing transparency for the general public; 3) consistency between directives on medical devices and on active implantable medical devices; 4) the decision-making process, by allowing binding decisions in case of conflicting national interpretations on whether or not a product is a medical device.
Medical devices are currently regulated by three major directives covering, respectively, active implantable medical devices, medical devices and in vitro diagnostic medical devices. Due to the technical differences between the three directives, the Commission has taken position against merging the directives. As things stand, therefore, the regulation will be tightened up via clarifications to the rules in order to ensure consistency of interpretation and of implementation.
Comments can be submitted by email. The consultation is open until 20 June 2005 at the following address: http: //europa.eu.int/comm/enterprise/medical_devices/index.en.htm.