Services
Clinical evaluations
For medical devices according to EU MDR (Regulation (EU) 2017/745) Article 61 & Annex XIV
medXteam accompanies you as a specialist for clinical data and regulatory affairs along all phases of the clinical evaluation process: from planning and literature search to the finished report – efficiently, digitally and with review by our medical experts.
Why an MDR-compliant clinical evaluation is crucial
Clinical evaluation is the central element of a medical device's technical documentation. It demonstrably proves that your product is safe and effective, provides clinical benefit, and meets all requirements of the EU MDR. Errors or omissions often lead to inquiries from notified bodies or delays in the approval process.
Clinical evaluation as the central element:
- Mandatory requirement under Article 61 & Annex XIV MDR
- Notified bodies conduct rigorous audits and expect full traceability
- Closely linked to risk management & PMCF
Our performance promise
We don't just deliver a document – we deliver a fully audit- and notified body-compliant clinical evaluation file .
This includes:
phase | Performance | Benefit |
|---|---|---|
Planning (CEP) | Creation of CEP including target definition, equivalence strategy, evaluation methodology | Clear evaluation framework from the start |
Literature review | Automated literature search based on a literature search plan. Documentation of the results in a report including a search log. | Efficient, traceable and documented procedure |
Assessment & Reporting (CER) | Evaluation of data availability, benefit/risk analysis, interface with risk management | Technically sound and robust arguments presented to notified bodies |
Regulatory & Medical Review | Medical review by our physicians and regulatory review by our RA specialists | Expert know-how across all areas (medical & regulatory) creates an integrated view |
Following the initial clinical assessment: | Ensuring consistent documentation during updates | Compliance with the requirements of the MDR as well as time and resource savings in follow-up projects |