Approval of Active Medical Devices

Decipher the regulatory requirements for active medical devices

Active medical devices are devices that rely on electrical energy or any other source of power other than that which is provided by the body or gravity. Examples of active medical devices include MRI scanners, infusion pumps and defibrillators. Active medical devices tend to be more complex in nature than non-active medical devices. Therefore, they are often subjected to more stringent requirements for testing and certification. A majority of active medical devices use electricity as their source of energy. As with other medical devices, high risk active medical devices are generally required to have a design dossier reviewed by a notified body.

In the European Union, certain active medical devices may also have to comply with the EU Directive 2002/95/EC, also known as the RoHS Directive, which restricts the use of hazardous substances in electrical and electronic equipment. Due to the inclusion of electronic components in active medical devices, the EU Directive 2002/96/EC which is also known as Waste Electrical and Electronic Equipment (WEEE) Directive may be applicable for certain active medical devices. In addition, the EU Directive 99/5/EEC, the Radio and Telecommunications Equipment (R&TTE) Directive, may also be applicable.

Within active medical devices is a sub-group of devices that are implantable in the human body. This group of medical devices is referred to as Active Implantable Medical Devices (AIMD). Examples of active implantable medical devices include pacemakers and cochlear implants. In the European Union, the 90/385/EEC directive sets the outline for an Active Implantable Medical Device (AIMD) to be placed on the European market.