ABSTRACT

The Active Implantable Medical Device Directive (AIMDD) covers the placing on the market and putting into service of a subset of products in the medical device sector. To qualify under the AIMDD, a product must be a medical device that is, at the same time, both “active” and “implantable.” The “device” definition relates to a product intended by the manufacturer for a medical purpose “whether used alone or in combination, together with any accessories or software for its proper functioning” (Directive 90/385/EEC §1(2(a))).