Timeline and Minimum Cost for CE Certification Class IIa Without Clinical Trial

Question

How long does it typically take to obtain CE certification for a Class IIa medical device without the need for a clinical trial ("klinische Prüfung")? What is the minimum cost involved?

Dr. Oliver Eidel · Accepted Answer

If you have a skilled team and a working prototype, the absolute minimum timelines are:
• 2-3 months for setting up a full QMS (Quality Management System)
• 6 months for development and creation of Technical Documentation, including Clinical Evaluation Plan and Report
• 5 months for notified body review and audits, assuming no iteration is needed

However, these are optimistic estimates. In practice, it can easily take twice or three times as long due to dependencies, bottlenecks in finding a notified body, and document iterations. QMS and Technical Documentation can be developed in parallel. Officially, you should have a notified body engaged before starting device development.
Regarding costs, notified body fees typically start at 10,000–15,000 EUR for the initial review and audit (for small companies). Yearly audits and extra review loops will add to the cost. Technical documentation assessment is about 8,000–9,000 EUR per device, including one round of questions. More rounds increase the expense.

Timeline and Minimum Cost for CE Certification Class IIa Without Clinical Trial

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