What is necessary for a manufacturer to CE mark a device containing electrical parts that may cause EMC interference under MDD 93/42/EEC?

The correct choice is that CE marking under MDD 93/42/EEC is sufficient for a manufacturer to CE mark a device containing electrical parts that may cause EMC interference. The Medical Device Directive (MDD) 93/42/EEC provides a comprehensive framework for ensuring that medical devices meet essential safety and performance requirements. Under this directive, the manufacturer must carry out an assessment of the device to confirm that it complies with all relevant requirements, including those related to electromagnetic compatibility (EMC).

While the MDD requires compliance with the essential requirements, it also allows manufacturers to demonstrate this compliance by following harmonized standards. Although specific standards like EN ISO 60601 may be relevant for medical electrical equipment and addressing EMC concerns more explicitly, they are not mandatory for CE marking under the MDD. Instead, manufacturers have the flexibility to choose appropriate measures and standards to demonstrate compliance, which may include following only the essential requirements set forth by the MDD.

Therefore, as long as the manufacturer ensures that the device meets the essential requirements, CE marking under MDD 93/42/EEC is indeed sufficient, reinforcing the device's market authorization in the European Economic Area.