Manufacturers need to determine the appropriate conformity assessment route. For devices falling under Directive 93/42/EEC other than custom-made devices and devices intended for clinical investigation, the conformity assessment route depends on the class of the device, to be determined in accordance with certain rules (see Articles 9 and 11 of Directive 93/42/EEC).
In the case of in vitro diagnostic devices, the appropriate conformity assessment route is determined by lists (see Article 9 paragraph 2 and 3 of Directive 98/79/EC and Annex II).
The appropriate conformity assessment route for active implantable medical devices is determined without reference to classes or lists (see Article 9 of Directive 90/385/EEC).