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Medical Devices

MedNet as your Authorized Representative for medical devices acts as your legal entity towards the European authorities and fulfills on your behalf the obligations described in the Medical Device Directive MDD 93/42/EEC as well as additional services regarding the marketing of your medical devices within the European Community.

MedNet Services for Medical Devices

  • fast product registrations to the EU Competent Authorities
  • guidance in the preparation of Declarations of Conformity
  • guidance in the labeling and language requirements in Europe
  • Incident reporting to the Competent Authorities according to the local legal requirements and MEDDEV guidelines in each EU Member state
  • notification services for clinical investigations
  • application of Free Sales Certificates or Certificates of Marketability
  • provision of Certificates of product registration

What is a Medical Device?

According to the Medical Device Directive MDD 93/42/EEC a ‘medical device’ is defined as 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.

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