CE Marking
Important Steps in CE Marking Process
- Verify your product is a medical device regulated by EU Medical Device Directive
- Classify your medical device
- Determine Conformity Assessment Route for your product
- Identify likely conformity assessment route
- Identify applicable Essential Requirements (ERs)
- Identify relevant harmonized standards, EP monographs, other standards
- Conduct risk analysis & plan risk management
- Determine clinical evaluation needs (scientific literature or clinical investigation)
- Establish Technical File
- Select Notified Body, if necessary
- Select Authorized Representative, if required (For companies outside Europe)
- Ensure that Technical File is complete, accurate and controlled
- Draw up declaration of conformity and apply CE mark
- Establish Vigilance System
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