d1e638-1-1__para__4

Implantable medical devices (e.g., cardiac pacemakers, implantable cardioverter defibrillators, implantable pulse generators) and certain in-vitro diagnostic medical devices (e.g., instruments used for detection of transmissible agents for screening of blood for transfusion, blood glucose meters to be used with test strips for diabetic patients) are associated with high risks. A lack of continuity of power supply and a break of connection between the product and the respective portable battery therefore entails a high risk of compromising the safety of the patient (end-user). Implantable active medical devices and certain in-vitro medical diagnostic devices are considered to be relevant to the derogation in Article 11 (3). It is worth noting that the above-mentioned classification is determined by the intended use. It is the intended use, and not the accidental use of the device, that determines the device class.

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Source: EUR-Lex (Cellar) · retrieved 2026-09-07 · Text as adopted (Official Journal); later amendments are not incorporated in this text.