A manufacturer of a permanently implanted active device is seeking guidance on conformance. What advice should be given?

The correct response indicates that conformance to 90/385/EEC is essential for a permanently implanted active device. This directive specifically pertains to active implantable medical devices, which encompasses devices such as pacemakers and neurostimulators that are intended to be implanted into the human body and remain there for an extended period. Compliance with this directive ensures that the manufacturer adheres to safety, health, and environmental protection standards mandated by the European Union.

This directive outlines the essential requirements that active implantable devices must meet to receive CE marking, which signifies conformity to European health, safety, and environmental protection standards. By conforming to 90/385/EEC, the manufacturer can ensure that their device is not only safe but also effective for its intended purpose, thus facilitating market access in the EU.

The other options refer to different directives: 93/42/EEC pertains to general medical devices, 98/79/EC relates to in-vitro diagnostic devices, and stating that a CE mark is not required for active implantable devices is incorrect, as all such devices must comply with the relevant directives to be legally sold in the EU market.