EU IVDR PEP (Performance Evaluation Plan) 예시 (템플릿)

1. Scope

2. Applicable regulations, standards
- Applicable regulations, Applicable standards/guidance

3. Device information
- Product name / Code / Classification and rule / UDI
- Intended purpose (NPT or Self-test)
- Analyte / Marker
- Reference material or reference method
- specified target patient groups (Ex. NPT or self-test)

4. General safety and performance requirements (GSPR)
- Identification of the general safety and performance requirements as laid down in Sections 1 to 9 of Annex I that require support from relevant scientific validity and analytical and clinical performance data;
- appropriate statistical tools
- Risk management requirements

5. Development process

6. Scientific Validity / Analytical performance / clinical performance

7. Description of state of the art
- Description of the state of the art, including an identification of existing relevant standards, CS, guidance or best practices documents;
- Benefit risk ratio

8. Software reference data

9. Post-Market performance follow-up (PMPF)