Description

The Checklist for Technical Documentation is a vital tool for medical device manufacturers to ensure compliance with the European Union Medical Device Regulation (EU MDR). It provides a systematic overview of the essential documentation required for CE marking and market access within the EU. The checklist encompasses various aspects of technical documentation, including design and manufacturing specifications, risk management documentation, clinical evaluation reports, labeling and instructions for use, and post-market surveillance plans. By following the checklist, manufacturers can ensure that all necessary documentation is complete, accurate, and meets the stringent requirements of the EU MDR. Compliance with the Checklist for Technical Documentation is essential for demonstrating conformity with regulatory standards and ensuring the safety and effectiveness of medical devices for patients and users.