European Union Medical Device Regulations

Regulatory 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
  • diagnosis, monitoring, treatments, alleviation of, or compensation for, an injury or disability,
  • the investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
  • providing information by means of 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.

Accessory for a medical device means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);

Active device: means any device, the operation of which, whilst not being itself a medial device, is intended by its manufacturer to be used together with one or several particular medial device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical devices(s) in terms of its/their intended purpose(s);

Implantable device: means any device, including those that are partially or wholly absorbed, which is intended:

  • to be totally introduced into the human body, or
  • to replace an epithelial surface or the surface of the eye,

by clinical intervention and which is intended to remain in place after the procedure.

Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device.

Invasive device: means any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body.

Generic device group: means a set of devices having the same or similar intended purposes or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics.

Single-use device: means a device that is intended to be used on one individual during a single procedure.

Falsified device: means any device with a false presentation of its identity and/or its source and/or its CE marking certificates or documents relating to CE marking procedures. This definition does not include unintentional non-compliance and is without prejudice to infringements of intellectual property rights.

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

Regulatory Approval Process

Classification Approval procedure
Class I
  • Appoint an Authorized 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