The cost and time required to obtain EU CE certification for Class C medical devices can vary widely based on several factors:

Cost:

1. Notified Body Fees:

   • Initial Review and Certification: Typically ranges from €10,000 to €50,000 or more, depending on the complexity of the device and the Notified Body.
   • Additional Services: Costs for additional services, such as on-site audits, may be extra.

2. Technical Documentation Preparation:

   • Costs for consulting services, clinical trials, and testing can add significantly to the total cost. This can range from €10,000 to over €100,000, depending on the device and requirements.

3. Quality Management System (QMS):

   • Implementation and maintenance of a QMS in compliance with ISO 13485 can also involve significant costs.

Time:

1. Preparation of Documentation:

   • Developing and compiling technical documentation, including clinical evaluations, can take several months to a year.

2. Notified Body Evaluation:

   • Application Review: The review process typically takes 3 to 6 months, depending on the complexity of the device and the efficiency of the Notified Body.
   • On-Site Audits: Scheduling and conducting audits can add additional time, potentially extending the process by a few months.

3. Overall Timeline:

   • The entire process, from preparation to obtaining certification, generally takes between 6 months to 18 months.

These estimates can vary based on specific device characteristics, the Notified Body's workload, and the efficiency of your preparation process. If you have any particular needs or concerns, feel free to ask for more detailed advice!