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Medical Devices Regulations (2017/745)
The Medical Devices Regulations covers the regulatory requirements of the European Union for Medical Devices.
Compliance with the requirements of the Medical Devices Regulations 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 VIII of the Medical Devices Regulations).
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):
- Full quality assurance system (ISO 13485)
- Production quality assurance system
- Production verification
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:
- Full quality assurance system (ISO 13485)
- Type examination and product conformity verification
Class III devices are high risk. Examples are balloon catheters, prosthetic heart valves. Routes to compliance are:
- Full quality assurance system (ISO 13485)
- Type examination and product conformity verification
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 Regulations.
For all Classes a Technical File must be prepared, demonstrating compliance of
the device with the regulations' 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 Regulations.
Products shipped must bear the CE marking to show  compliance with the regulations. 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.
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