European Union Medical Device Regulations

Medical Device Definition
"Any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
  • Diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
  • Investigation, replacement or modification of the anatomy or of a physiological process
  • Control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means
Classification of Medical Device
International ClassificationExamplesRisk Level
Class IChemistry analyzerLow
Class IIaUrine test stripsLow - Moderate
Class IIbBlood Glucose self-testingHigh - Moderate
Class IIIHIV blood analyzerHigh
Premarket Approval Process
I (non-sterile, non-measuring)I (sterile, measuring)IIaIIbIII
Quality Management System (QMS) not required.Implement and provide proof of QSM (ISO 13485) compliance.
Appoint an Authorized Representative (AR) in country that device is to be sold in.
Submit technical file with necessary documentation and information.Submit design dossier
No audit required.Application will be audited by Notified Body (NB).
N/AIf approved, CE marking will be issued and will be valid for 3 years.
Prepare and submit Declaration of Conformity (DoC).
N/ASome countries within EU require additional registration of Class lla, llb or lll devices.
If approved, device registration will be granted.
Additional Information
ValidityThree Years.
Postmarket Surveillance Implementation of post market surveillance systems, adverse incident reportingprograms and vigilance activities is required.
TimelineClass III Devices: Approx. 6-9 months. All other devices: Approx. 3-6 months.
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