The Medical Devices Directive 93/42/EEC defines safety and reliability requirements for medical equipment to be sold in the EEC. The requirements apply to both products and manufacturers.
The Medical Devices Directive (MDD) applies to all general medical devices not covered by the Active Implantable Medical Devices Directive or the In Vitro Diagnostics Directive.
In order to be compliant with MDD, you need to classify your products correctly. The MDD divides products into different classes, based on risk and intended use, which again determines the relevant conformity assessment procedure. For products classified with medium to high degree of risk, the MDD requires a conformity assessment procedure involving a notified body, such as DNV Business Assurance.