Description
Performance Evaluation Report (PER) – EU IVDR
Comprehensive Performance Evaluation Report meeting EU In Vitro Diagnostic Regulation (IVDR 2017/746) requirements. We document scientific validity, analytical performance, and clinical performance for your in vitro diagnostic device, together with the benefit-risk analysis and post-market performance follow-up (PMPF) plan needed for CE marking.
Service Details
| Turnaround | Standard: 10–14 weeks, depending on risk class and data |
| Best for | CE marking of in vitro diagnostic devices under EU IVDR 2017/746 |
| Risk classes | Class A, Class B, Class C, and Class D IVDs |
| Evidence covered | Scientific validity, analytical performance, and clinical performance |
Regulatory Framework
- EU IVDR 2017/746 – Article 56, Annex XIII
- MDCG 2022-2 – Performance evaluation guidance
- CLSI Guidelines – Analytical performance standards
- EN ISO 20916 – Clinical performance studies
PER Components
- Device description and intended purpose
- State of the art
- Scientific validity assessment
- Analytical performance (sensitivity, specificity, precision, accuracy)
- Clinical performance evidence
- Benefit-risk analysis
- Post-market performance follow-up (PMPF) plan
- Performance evaluation conclusions
IVDR Risk Classification
- Class A – Low risk IVDs
- Class B – Moderate risk IVDs
- Class C – High risk IVDs
- Class D – Highest risk IVDs (companion diagnostics, blood screening)
How It Works
- Send us your device description, intended purpose, and the analytical and clinical performance data you have
- We assess scientific validity and prepare the PER
- You review the draft and we revise based on your feedback
- You receive the final Performance Evaluation Report
Which Service Do You Need?
This service is for in vitro diagnostic devices under the EU IVDR. For medical devices under the EU MDR, see Clinical Evaluation Report (CER) – EU MDR. For the instructions for use that accompany your device, see Instructions for Use (IFU) Development.
Frequently Asked Questions
Which regulations and guidance does the PER follow?
EU IVDR 2017/746 (Article 56, Annex XIII), MDCG 2022-2 performance evaluation guidance, CLSI guidelines for analytical performance, and EN ISO 20916 for clinical performance studies.
Which IVDR risk classes do you cover?
Class A (low risk), Class B (moderate risk), Class C (high risk), and Class D (highest risk, including companion diagnostics and blood screening).
Does the PER include post-market planning?
Yes. A post-market performance follow-up (PMPF) plan is one of the PER components.
How long does a PER take?
The standard timeline is 10–14 weeks, depending on risk class and data.
Get started: add this service to your cart, or email co*****@*******se.com with your device description, risk class, and the performance data you have to discuss scope.
