What advice should be given to a manufacturer of a permanently implanted active device regarding Essential Requirements?

The advice to the manufacturer of a permanently implanted active device to ensure conformance to 90/385/EEC is pertinent because this Directive specifically relates to active implantable medical devices. It outlines essential requirements that such devices must meet to ensure safety and performance. This Directive addresses the unique risks associated with active devices, particularly those that are implanted, emphasizing their long-term interaction with the body and the need for stringent testing and compliance.

The other options refer to different regulations. Conformance to 93/42/EEC pertains to general medical devices and would not capture the specific nuances required for active implantable devices. Similarly, 98/79/EC addresses in-vitro diagnostic devices, which do not apply to permanently implanted active devices. Lastly, stating that a CE Mark is not required for active implantable devices is incorrect, as compliance with the relevant directive and obtaining a CE Mark is indeed necessary to demonstrate conformity and market access within the EU.