Essentials of European Medical Device Regulatory Affairs - October 2019

Active Medical Device • Any medical device operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy. • Hearing aids, TENs machines, light boxes to treat SAD • Stand alone software is considered to be an active medical device. Ref: Directive 93/42/EEC Annex IX Sect 1.4 An active non implantable regulated by this directive. Active implantable regulated by Directive 90/385/EEC

MEDDEV 2.1/6 Guidance on software (what is and what is not a medical device)

65

How to Apply the Rules

• Manufacturer decides on the basis of the decision rules in the Directive (Annex IX) and the intended purpose of the device

• Decision criteria: time, invasiveness, powered or not (active/non-active), presence of drugs

• All rules must be considered • For multipurpose devices the highest class applies

66