What are the directives?
The Directives that are most relevant to medical device manufacturers are the Medical Devices 93/42/EEC and Medical Devices in Vitro Diagnostics 98/79/EC. Products can be covered by more than one Directive. Whether one or more Directive applies, manufacturers must ensure that their product meets the requirements set out in the Directive(s), together with the standards issued under the authority of the Directive.
