What documentation is required for successful market entry under Regulation (EU) 2017/746?
The exact documentation required will change on a case to case basis, and the detail expected will depend largely on the risk classification of the device. The following documentation is generally required by default:
- Device Description and Specification
- Classification Rationale
- Applicable Standards List
- Information Supplied by the Manufacturer: Includes IFUs and Labelling
- Design and Manufacturing Information
- General Safety and Performance Requirements Checklist
- Risk Management
- Product Verification and Validation
- Performance Evaluation Report
- Stability
- Software V&V
The most resource intensive section will be the Product Verification and Validation which is the main body of evidence of scientific validity, analytical and clinical performance. A robust Performance Evaluation Plan is key in ensuring all regulatory requirements are met, and that all claims are scientifically substantiated.
