How much does CE Certification Cost?

When you need to budget for medical device CE Certification, the following cost should be considered

1. Cost of testing as per the harmonized standard
2. Notified Body Fees including auditor travel
3. Consultants fees towards guidance and preparation of Technical File/Design Dossier
4. Annual Surveillance Audit
5. ISO 13485 Implementation and CE certification cost

Please click here to know more about Medical Device CE Marking Fees in detail and the major areas of expenses and related pricing.

Important
New documents published by the EU Commission insists for Notified Body direct audit once in 18 months on all clients. This will be an added cost to clients.

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