Description

The General Safety and Performance Requirements (GSPR) checklist is a fundamental tool for medical device manufacturers to ensure compliance with the European Union Medical Device Regulation (EU MDR). It serves as a comprehensive guide outlining the essential safety and performance criteria that medical devices must meet to obtain CE marking and be placed on the market in the EU. The GSPR checklist covers a wide range of requirements, including design and manufacturing specifications, risk management, labeling and instructions for use, clinical evaluation, and post-market surveillance. By systematically reviewing and addressing each item on the GSPR checklist, manufacturers can demonstrate conformity with regulatory standards and ensure the safety and effectiveness of their medical devices for patients and users.