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European Union Medical Device Regulations

Agency
The European Commission is responsible for regulating medical devices in Europe.
Medical Device Definition
A medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
  • diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease, an injury, or disability.
  • investigation, replacement or modification of the anatomy or of a physiological or pathological process or state.
  • providing information using in vitro examination of specimens derived from the human body, including organ, blood, and tissue donations and which does not achieve its principal intended action by pharmacological, immunological, or metabolic means, in or on the human body, but which may be assisted in its function by such means.
Medical Device Classification System
International Classification Risk Level Examples
Class Im (Measuring) Low risk Wheelchairs, stethoscopes, Spectacles
Class Is (Sterile)
Class Ir (Reusable surgical)
Class IIa Medium risk Dental fillings, Surgical Clams, Tracheotomy tubes
Class IIb Medium/High risk Lung ventilators, Bone fixation plate, Condoms
Class III High risk Pacemakers, Heart valves, Implanted cerebral, simulators
Approval Process
Classification Approval procedure
Class I
  • Appoint an Authorised Representative.
  • Determine the class of the device on the basis of risk classification system.
  • Depending on the class of the Medical Device, follow the Conformity Assessment Procedure.
  • Must have a QMS for class I devices, the QMS system does not have to be certified by a notified body.
  • Technical documentation must be submitted as a part of Conformity Assessment Procedure for the market authorization of Medical Devices.
  • Clinical Evaluation Report should be prepared in case of high risk devices to ensure the safety and performance (including the clinical benefit) of the device when used as intended by the manufacturer.
  • After approval, a CE Marking Certificate for your device will be issued after an audit by a notified body.
  • Prepare a declaration of conformity.
    		•
    Class IIa
    Class IIb
    Class III
    Additional Information
    Approval timeline N/A
    License validity period 5 Years
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