Clinical & Performance Evaluation for Medical Devices and IVDs
We support manufacturers of medical devices and In Vitro Diagnostic medical devices with strategic and tailored Clinical & Performance Evaluation solutions.
Fully aligned with the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746).
What is the point ?
Clinical and Performance Evaluations form the foundation of compliance with the European Medical Device and In Vitro Diagnostic Regulations (MDR and IVDR). They demonstrate that your product is safe, performs as intended, and provides a real clinical and performance benefit for its users.
In practice, the evaluation involves collecting, appraising, and analyzing all available clinical or performance data — from scientific literature, in-house testing, and, where needed, clinical studies — to build a robust evidence base supporting your claims.
A well-executed evaluation helps you:
- Define a clear evidence and data generation strategy early in development
- Identify gaps that may require a clinical investigation or performance study
- Form the basis for designing a clinical study, when additional data is needed
- Ensure alignment between design, risk management, and post-market activities
- Build confidence with Notified Bodies, regulators, and the market
Ultimately, the Clinical or Performance Evaluation is not just a regulatory requirement — it’s a strategic tool to demonstrate value, guide clinical development, and secure long-term market success.
Why Choose Us?
- Deep expertise in MDR, IVDR and relevant guidance documents and standards.
- Proven success with notified body submissions.
- Tailored strategies for every device class, including software.
- Transparent and cooperative approach