Technical Documentation Best Practices for EU MDR
Manufacturers shall ensure the conformity of medical devices being placed on the European market in accordance with the applicable requirements of (EU) 2017/745 Medical Devices Regulation (MDR). Depending on the classification of the device and the conformity assessment route chosen, one or more Technical Documentation(s) need to be assessed by a Notified Body. This whitepaper is aligned to the requirements of EU Medical Devices Regulation (EU MDR), described in detail in Annexes II and III.
This Whitepaper focused on ideal structure of Technical Documentation:
- Device description and specification details
- Reference to previous and similar generations of the device
- Design & Manufacturing Information
- General Safety & Performance Requirements (GSPRs)
- Benefit Risk Analysis and Risk Management
- Product Verification and Validation
- Clinical Evaluation (Includes SSCP labelling)
- Post Market Surveillance
