The cost and time required to obtain Class B medical device CE certification in the EU can vary depending on several factors, including the complexity of the device, the Notified Body chosen, and the preparation of documentation. However, here are general estimates:

Cost:

1. Notified Body Fees: The cost for Notified Body services can range from €5,000 to €15,000 or more. This includes the review of technical documentation and QMS, as well as audit fees.

2. Technical Documentation Preparation: Costs for preparing technical documentation, including clinical evaluations and risk assessments, can vary widely. It might range from €5,000 to €20,000 depending on the complexity of the device.

3. Quality Management System (QMS): Implementing a QMS compliant with ISO 13485 can incur additional costs for consultancy, training, and documentation, which might range from €10,000 to €30,000.

4. Additional Costs: There may be additional costs for translation, testing, and other regulatory requirements.

Time:

1. Preparation: Preparing the technical documentation and establishing a QMS can take several months, depending on the readiness of the information and processes.

2. Review by Notified Body: The review process by the Notified Body generally takes between 3 to 6 months. This includes the time for initial review, potential requests for additional information, and final assessment.

3. Certification Issuance: After successful assessment, the Notified Body issues the CE certificate, which can take an additional few weeks.

Overall Timeline:

From start to finish, the entire process to obtain CE certification for a Class B medical device can typically take from 6 to 12 months. This timeframe accounts for preparation, review, and certification issuance.

It's advisable to consult with a Notified Body or regulatory consultant for more precise estimates tailored to your specific situation.

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