Active Implantable and 'general' medical devices

Active implantable medical devices are regulated by Directive 90/385/EEC and 'general' medical devices are regulated by Directive 93/42/EEC.

First the manufacturer needs to consider that the product falls within the scope of the relevant directive (external link). The European Commission has prepared some useful guidance on the definitions of the terms ‘medical devices’, ‘accessory’ and ‘manufacturer’ in  MEDDEV 2.1/1 (external link).

The manufacturer's products must meet all of the relevant essential requirements contained in the relevant annex of the appropriate directive. Depending on the device, this may include:

  • biological safety
  • clinical data
  • electrical safety
  • electromagnetic compatibility
  • labelling and instructions
  • risk management
  • sterilization.

Where available, relevant harmonised standards (external link) may be used to demonstrate how many of the requirements have been met.

In addition, there is European Commission guidance on clinical investigation and clinical evaluation (MEDDEV 2.7) on the Europa website (external link).

Manufacturers of ‘general’ medical devices will also need to determine the classification of their products. Active implantable devices are regarded as falling within the highest risk category.

Once this has been determined they will need to follow the appropriate conformity assessment procedure. This may require them to have their quality systems and technical documentation reviewed by a notified body before they can place their products on the market. The body will need to assure itself that relevant requirements have been met before issuing relevant certification. Manufacturers can then place the CE marking on their products to demonstrate their compliance with the requirements.

 ‘General’ medical devices encompass an extremely wide range of products, for example: 

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

Examples of active implantable medical devices include:

  • implantable cardiac pacemakers
  • implantable defibrillators
  • leads, electrodes, adaptors for the above
  • implantable nerve stimulators
  • bladder stimulators
  • sphincter stimulators
  • diaphragm stimulators
  • cochlear implants
  • implantable active drug administration device
  • catheters, sensors for item above
  • implantable active monitoring devices
  • programmers, software, transmitters.

Page last modified: 14 November 2013