Performance Evaluation & IVDR compliance

We help you develop and maintain the two key documents essential under the IVDR:

• Performance Evaluation Plan (PEP): Defines the strategy, scope, and methods for collecting and evaluating performance data.
• Performance Evaluation Report (PER): Summarizes the results of the evaluation, including conclusions about the benefit-risk profile of the device.

Both documents must be continuously updated as new data becomes available through Post-Market Surveillance (PMS) and Post-Market Performance Follow-up (PMPF).

The IVDR requires a structured evaluation framework for the performance evaluation consisting of:

1. Scientific Validity
2. Analytical Performance
3. Clinical Performance

We work closely with our clients to define the intended use and risk classification of the IVD, allowing us to tailor a compliant and defendable evaluation strategy.

Demonstrated in accordance with IVDR Annex XIII, Section 1.2.1, using one or more of the following methods:

• Published literature on similar markers or analytes
• Peer-reviewed scientific publications
• Consensus opinions from professional bodies
• Proof-of-concept studies
• Clinical performance study results

At BioTop Medical, we perform systematic literature reviews, appraise the collected evidence, and compile a Scientific Validity Report identifying any remaining data gaps.

Analytical performance characteristics—outlined in IVDR Annex I, Section 9—are verified through appropriate testing.

Upon receiving analytical test reports, we analyze the results and prepare a summary report confirming the IVD’s ability to reliably detect or measure the intended analyte. Our reports follow a defined methodology and are fully aligned with Notified Body expectations.

A Clinical Performance Study may be required under IVDR Annex XIII, Section 1.2.3 when existing data is insufficient to support the ability of an IVD to yield results which are correlated with a particular clinical condition or a physiological or pathophysiological process or state in a target population by the intended user.

At BioTop Medical, we apply EN ISO 20916:2024 for all clinical performance studies involving human specimens. We assist in:

• Designing compliant study protocols
• Navigating ethics committee and regulatory approvals
• Integrating results into the overall Performance Evaluation Report (PER)

This begins with a clear understanding of your IVD’s intended purpose and clinical claims. We support you in:

• Defining study objectives and selection criteria
• Developing a compliant study protocol
• Ensuring traceability and proper documentation
• Generating reproducible clinical performance data

The documentation required under EN ISO 20916:2024 includes:

• Clinical Performance Study Protocol
• Investigator’s Brochure
• Informed Consent Form
• Ethics Committee submissions
• Monitoring reports and data logs
• Final Clinical Performance Study Report
• Integration into the Performance Evaluation Report (PER)

BioTop Medical helps you prepare, review, and align all documentation for regulatory submission and Notified Body review.