We support our clients while obtaining CE Mark and Declaration of Conformity with:

  •  Selection of the appropriate notified body (except for Class I MD and A IVD)
  •  Preparation of relevant applications and documentation – formal and substantive compliance
  •  Preparation and planning of the audit and/or Certification audit assistance

In order to commercialize medical devices in the European Union, a CE Mark certificate is needed. This certification verifies that a device meets all regulatory requirements for medical devices under the new Medical Devices Regulation (MDR 2017/745). Clinmark’s team has wide experience in the preparation and planning of every stage of CE Marking Regulatory Process. Our experts assist clients in the conformity assessment of a medical device in cooperation with a notified body.

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