Medical Devices Directive
The Medical Devices Directive covers the regulatory requirements of the European Union for Medical Devices. Active implantable devices (e.g. pacemakers, implantable infusion pump) are covered by a separate directive, the Active Implantable Medical Devices Directive.
Compliance with the requirements of the Medical Devices Directive is declared by placing the CE Marking on the product, and supplying the device with a Declaration of Conformity.
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
sterile products and devices with a measuring function must apply to a Notified Body for certification of the aspects of manufacture relating to sterility or metrology.
Class IIa are low-medium risk devices, with examples such as hearing aids, electrocardiographs, ultrasonic
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 (ISO 13485)
- Audit of the production quality assurance system
- Audit of final inspection and testing
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 (ISO 13485) 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
Most of the routes to compliance above require the involvement of a Notified Body. A Notified Body is an
organization appointed by the national accreditation authorities and "notified" to the European Commission to approve products covered by the Medical Devices Directive.
For all Classes a Technical File must be prepared, demonstrating compliance of
the device with the directive's essential requirements. Compliance can be assumed by showing conformity to the appropriate standards listed by the European Union as Harmonised Standards for the Medical Devices Directive.
Products shipped must bear the CE marking to show compliance with the directive. If a Notified Body is involved in the approval, the number of the Notified Body must also appear adjacent to
the CE marking.
Additionally, the product must be shipped with a Declaration of Conformity.