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.