EU legislation on CE-marking: Medical devices (case)

In order to market medical devices in the EU, the products must be marked with the CE mark. In order to qualify for the CE mark, a company must meet the criteria as set out in the EU Directives on Medical Devices: 93/42/EC (general); 98/79/EEC (in vitro); 90/385/EEC (implantable).
This document looks at some issues when preparing for CE marking, namely relation with international quality management systems, the role of notified bodies, and estimated costs.