Performance Evaluation for In Vitro Medical Devices
We support manufacturers of IVDs with strategic and tailored Performance Evaluation solutions, fully aligned with the EU In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746).
Our Performance Evaluation Services
- Performance Evaluation Strategy development tailored to your device
- GAP analysis for existing evaluation documentation
- Preparing PEPs and PERs, whether it is a new device or legacy device
- Literature search and state-of-the-art assessment
- Support with Notified Body clinical reviews
What Is a Performance Evaluation Report (PER)?
A PER for medical devices is a comprehensive document that demonstrates the clinical evidence under MDR Annex XIV Part A, which aims to demonstrate safety, performance, and benefit-risk profile of your device.
It includes:
- Systematic literature review and evaluation of existing data
- Appraisal and analysis of analytical and clinical performance studies
- Equivalence assessment (where applicable)
- Integration with Post-Market Performance Follow-Up (PMPF), as well as Risk Management and PMS
Do all devices need one?
- Yes — all IVD devices require a performance evaluation, regardless of risk class.
The depth and extent depend on the device type, intended purpose, and available performance data
Why Choose Us?
- Solid expertise in IVDR and guiding documents
- Proven track record with Notified Body clinical reviews
- Support across all device risk classes and therapeutic areas
- Transparent, audit-ready documentation
- Strategic guidance for CE marking and market access
Ready to Strengthen Your Clinical Evidence?
Whether you’re wondering how to develop a performance evaluation plan or report or need a full-service partner or ad-hoc support, we’re here to help. Let’s build a compliant, efficient, and scientifically sound pathway to CE marking.
Contact us today to discuss your device, your needs, and receive a customized proposal!