Medical Devices Directive

It covers an extremely wide range of products, including, for example:

• first aid bandages
• tongue depressors
• hip prostheses
• X-ray equipment
• ECG
• heart valves
• spectacles
• dental materials

A copy of the directive (external link) can be found on the Europa website.

A number of additional Directives amending the original Directive have since been introduced:

• Directives 2000/70/EC (external link) and 2001/104/EC (external link) which brought medical devices incorporating stable blood derivatives within the scope of the general directive.
• Directive 2003/12/EC (external link) which reclassified breast implants into Class III.
• Directive 2003/32/EC (external link) which lays down detailed specifications in relation to risks of transmitting transmissible spongiform encephalopathies (TSE) under normal conditions of use to patients or others, via medical devices manufactured utilising animal tissue which is rendered non-variable or non-viable products derived from animal tissue.
• Directive 2005/50/EC (external link) which reclassifies total hip, knee and shoulder joints into Class III.
• Directive 2007/47/EC (external link) which doesn’t come fully into force until 21 March 2010 but will amend the Medical Devices and Active Implantable Medical Devices Directives following a review of the existing provisions by the European Commission and member states.
• Interpretative documents (external link)