Description
The EU MDR Technical Documentation Kit includes the following documents:
| Topic | Procedure Title |
|---|---|
| EU MDR Specific Templates | GSPR Checklist for EU MDR 2017/745 |
| Â | Declaration of Conformity Template |
| Â | Requirements Checklist for Technical Documentation According to EU MDR 2017/745 |
| Â | Strategy for Regulatory Compliance Procedure |
| Â | PRRC Designation Letter Template |
| Â | Â |
| Post Market Surveillance | Post-market Surveillance Template |
| Â | Periodic Safety Update Report Template |
| Â | Post-market Surveillance Report Template |
| Â | Â |
| Risk Management Process | Risk Management Procedure |
| Â | Risk Management Plan Template Risk Management Report Template Risk Analysis Template Hazard Analysis Template Traceability Matrix Template |
| Â | Â |
| Usability | Usability File Template |
| Â | ISO 62366 USability Requirements Checklist |
| Â | Â |
| Biocompatibility | Biological Risk Assessment Template |
| Â | Â |
| Labelling | ISO 20417 Compliance Checklist |
| Â | Â |
| Â | Â |
| Â | Â |
