CE mark & Kitemark for medical devices

Medical Devices - your access to the european market with BSI

CE marking for medical devices 

CE marking for Medical Devices

CE marking is a legal requirement for medical devices intended for sale in Europe.

There are three European CE marking Directives that specifically apply to medical devices manufacturers:

  • The Medical Devices Directive (MDD) applies to all general medical devices not covered by the Active Implantable Medical Devices Directive or the In Vitro Diagnostics Directive.
  • The Active Implantable Medical Devices Directive (AIMDD) applies to all active devices and related accessories intended to be permanently implanted in humans.
  • The In Vitro Diagnostics Directive (IVDD) applies to all devices and kits used away from the patient to make a diagnosis of patient medical conditions.

BSI is designated as a Notified Body with a comprehensive scope under the MDD and the AIMD and can provide the full scope of services under the IVD Directive. These services include:

  • Technical documentation/file or design dossier assessment/review
  • Device type examination
  • Product quality assurance (based in ISO 13485)
  • Production quality assurance (based in ISO 13485)
  • Full quality assurance (ISO13485)
  • Batch verification/release

View the CE Marking for Medical Devices Brochure


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Apply for CE marking for medical devices.  For further information contact a BSI advisor now.

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CE marking for Medical Devices

CE marking for Medical Devices

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