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 Classification Examples Risk Level
Class I Chemistry analyzer Low
Class IIa Urine test strips Low - Moderate
Class IIb Blood Glucose self-testing High - Moderate
Class III HIV blood analyzer High
Premarket Approval Process
I (non-sterile, non-measuring) I (sterile, measuring) IIa IIb III
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/A If approved, CE marking will be issued and will be valid for 3 years.
Prepare and submit Declaration of Conformity (DoC).
N/A Some countries within EU require additional registration of Class lla, llb or lll devices.
If approved, device registration will be granted.
Additional Information
Validity Three Years.
Postmarket Surveillance Implementation of post market surveillance systems, adverse incident reporting programs and vigilance activities is required.
Timeline Class III Devices: Approx. 6-9 months. All other devices: Approx. 3-6 months.