CE Marking is more than just a label—it’s proof that your medical device meets strict regulatory requirements. Having the right documentation in place is crucial for gaining approval and entering the market without delays.
The technical file is the foundation of CE compliance. It must include:
ISO 14971 requires a systematic approach to identifying, assessing, and mitigating risks. Ensure your risk management file is comprehensive and updated throughout the product lifecycle.
This document demonstrates that your device is safe and performs as intended, based on clinical data and scientific literature. A strong CER strengthens your regulatory submission.
A formal statement signed by the manufacturer confirming that the product meets all applicable EU regulations and standards. This document is mandatory for CE Marking.
Regulatory bodies expect manufacturers to monitor product performance after launch. Include a clear PMS plan that outlines how you will collect, analyze, and respond to post-market data.
Accurate labeling and user instructions are essential for compliance. They must match the claims in your technical file and be easy for end-users to understand.
Without the right documentation, achieving CE Marking success is impossible. By preparing comprehensive files and maintaining a robust document management system, you can streamline approval and ensure long-term compliance.