The Medical Devices Directive 93/42/EEC defines safety and performance requirements for medical equipment sold in the European Union. The requirements apply to both products and manufacturers, generally to all medical devices not covered by the Active Implantable Medical Devices Directive or the IVD Directive (In Vitro Diagnostics).
In order to obtain medical device approval in the EU, medical devices must be correctly classified. The Medical Device Directive defines products into different classes, based on risk and intended use, which determine the relevant conformity assessment procedure in Annex IX. For products classified with medium to high degree of risk (class Is, Im, IIa, IIb and III) the Medical Device Directive requires a conformity assessment procedure involving a notified body.
Presafe Denmark A/S is a member of the European Association of Notified Bodies for Medical Devices and is appointed notified body for all medical devices under the Medical Devices Directive, annexes II, V and VI, with notified body number 0543.