Products intended for commercial distribution in European markets are required to have CE mark on them. It is the manufacturer’s declaration that the product complies with all the essential requirements of regulations such as the European Medical Device Directive, therefore ensuring the safety of the product.
CE marking of medical devices usually involves a special authorized third party, a Notified Body, which conducts a Conformity Assessment for the product. As a sign of conformity, a CE mark also includes the identification code of the notified body when applicable. Co-operation between the manufacturer and notified body is continuous throughout the product lifetime and even beyond.
CE Mark process includes:
- Qualification and classification of the medical device
- Identifying the applicable requirements of the directive(s)
- Selecting a suitable conformity assessment procedure
- Finding and tendering external partners such as a notified body and test labs
- Creating documentation to support the evaluation of the product
- Product specification
- Intended use
- User documentation
- Technical documentation (technical file)
- Essential requirements checklist
- Declaration of Conformity
- Enhancing the Quality Management System based on relevant regulations
- Executing and participating in audits
- Updating the documentation during the process
TAKSO can offer project management, consulting, coaching and support throughout the CE marking process or give guidance and help in individual steps during the process. References for CE marking processes vary from start-ups to global giants.