CE Marking for Medical Devices

Europe

CE Certification Strategy

To sell medical devices in the European Union, you must apply CE Marking for your product. CE Marking indicates that your medical device complies with the applicable EU Regulations. The regulation outline the safety and performance requirements for medical devices in the EU.

Qserve can help you with the European CE approval process for medical devices and IVD products.

CE Marking process: 

• Determine which EU directive applies
• Determine the classification
• Determine Conformity Assessment Procedure
• Notified Body selection
• Prepare a Technical file or Design dossier
• Prepare a Clinical Evaluation Report
• Implement or update the Quality Management System
• Select a European Authorized Representative, if required.
• Appoint a Person Responsible for Regulatory Compliance
• Internal audit for your QMS and Technical file
• Submit to Notified Body 
• Declare Conformity of Medical Device
• Collect data (PMS, PMCF)