The routes to compliance depend on the classification of the product.(Note that the full classification rules are given in Annex IX of the Medical Devices Directive).
Class I devices are low risk.Examples are stethoscopes,hospital beds,wheelchairs.The manufacturer has to produce a technical file,including product test results to relevant standards.In addition,manufacturers of steriles and devices with a measuring function must apply to a Notified Body for certification of the aspects of manufacture relating to sterility or metroligy.
Class IIa are low-medium risk devices,with examples such as hearing aids,electrocardiographs,ultrasonia diagnostic equipment.As for Class I,the manufacturer produces a technical file,but in addition a conformity assessment must be carried out by a Notified Body,according to one of the following routes(at the manufacturer's choice):
- Examination and testing of each product or homogenous batch of products.
- Audit of the full quality assurance system(EN 46001)
- Audit of the production quality assurance system(EN 46002)
- Audit of final inspection and testing (EN 46003)
Class IIb are medium-high risk devices,with examples such are surgical lasers,infusion pumps(non-implantable),ventilators,intensive care monitoring equipment.Routes to compliance are the same as for Class IIa,with the addition of Type Examination of the product by the Notified Body,except for the full quality assurance route(EN 46001),where Type Approval is not necessary.
Class III devices are high risk.Examples are balloon catheters,prosthetic heart valves.Routes to compliance are:
- Audit of the full quality assurance system(EN 46001)and examination of the design dossier by the Notified Body
- Type Examination of the product together with
- examination and testing of each product or homogenous batch of products or
- audit of the production quality assurance system(EN 46002)