Hitec Medical MDR training – Technical Documentation Requirements under MDR (Part 1)
| Elements | Content |
| Device description, included software and accessories | General description of the product, including intended use and intended users; UDI; indications and contraindications; instructions for use; user requirements; product classification; model list; material description; and performance indicators. |
| Information provided by the manufacturer | Labels on products and their packaging, instructions for use. (Use a language acceptable to the Member State where the device is intended for sale) |
| Design and manufacturing information | Complete information and specifications for understanding the design phase of the device, the manufacturing process and its validation, continuous monitoring and final product testing.
Identify the site where design and manufacturing activities will take place, including subcontractors. |
| General Safety Performance Requirements GSPR | Demonstration information for general safety and performance requirements in Appendix I; includes justification, validation and verification of solutions adopted to meet the requirements. |
| Risk-benefit analysis and risk management | The risk benefit analysis and risk management results are included in Appendix I. |
| Product Validation and Verification | Should contain the results and critical analyzes of all verification and validation tests/studies performed |
Labeling requirements under MDR
Post time: Dec-29-2023