CE Marking / Devices

Medical Device CE Marking Compliance Services

A Medical Device (MD) is defined in Directive (93/42/EEC) as:

β€œAny instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application 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 by such means.”

Pharmafile can provide clients with full support services in respect of classification, preparation and submission to the selected notified body. For clients outside the European Union Member States, Pharmafile can offer an authorised representative to act on their behalf and to ensure compliance with CE Marking requirements by carrying out certain tasks including:

  • Dealing with the regulatory authority

  • Keeping, for a period extending to at least 5 years after manufacture of the product, the updated Technical Documentation (or Technical File) available for review and inspection by EU Competent and/or Surveillance Authorities

  • Registering, notifying and/or updating class I and in vitro diagnostic medical devices with the EEA competent Authorities

  • Assisting in vigilance/incident reporting, product recalls and the issuing of advisory notices

For more information please contact us at: enquiries@pharmafile.ie

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HOW PHARMAFILE CAN HELP