This directive, along with two associated directives, the Medical Devices Directive and the In Vitro Diagnostic Devices Directive, cover all medical equipment.

The changes introduced by the amendment include:

• Aligns the definition of Medical Device, Custom Made Device, Intended Purpose, Clinical Data and Authorised Representative -with the MDD

• Specific inclusion of stand alone software in the definition of a medical device.

• Devices that administer a medicine which is liable to act on the human body with action that is ancillary to that of the device are covered by the AIMDD without prejudice to the provisions of the Medicines Directive 2001/83/EC with regard to the medicine.

• Devices that incorporate a medicinal product constituent or a medicinal product derived from human blood or human plasma and which is liable to act on the human body with action that is ancillary to that of the device are covered by the AIMDD.

• Medicines, human blood, blood products, plasma or blood cells of human origin and transplants etc, except as mentioned above are excluded from the AIMDD.

• Custom made devices also will be subject to post market surveillance, and the particular patient for whom the device has been made must be supplied with certain information.

• Medical devices that are also machines as defined by the Machinery Directive (2006/42/EC) will generally need to be assessed against the essential health & safety requirements of that directive.

• Additional requirements for custom made devices and devices intended for clinical investigation relating to the use of animal tissues and human blood derivatives.

• If the manufacturer is based outside of the EU, he must appoint an Authorised Representative to act on his behalf.

• Post market surveillance activities are extended to include trend reporting.

• The Technical File must be kept for 15 years from the manufacture of the last appliance.

• Foetal distress and death, congenital abnormality and birth defects are added to the list of incidents that mandate reporting to the MHRA.

• The Instructions for Use and the Declaration of Conformity must be controlled documents within the manufacturer’s quality management system.

• The quality management system must include procedures describing post market surveillance activities associated with the device.

• The quality management system must include procedures describing the risk assessment associated with the device.

• Third Party subcontractors will be more closely monitored by the notified body.

• Pre-clinical evaluation data must be included in the technical file.