Clinical evaluation
Complete package (CEAAS)
Clinical evaluation according to EU-MDR (Regulation (EU) 2017/745), Article 61 and Annex XIV
Do you want to entrust your clinical evaluation to experienced professionals and focus on your product? medXteam handles the entire process. As specialists in clinical data and regulatory affairs, we support you through all phases of the clinical evaluation – from planning (CEP) and audit-proof literature searches to the finished Clinical Evaluation Report (CER), efficiently, digitally, and with an independent review by our medical experts.
The result is not just a document, but a complete, audit- and notified body-compliant clinical evaluation file that meets the requirements of the MDR and the expectations of the notified bodies.
Why an MDR-compliant clinical evaluation is crucial
The clinical evaluation is the central element of the technical documentation. It demonstrably proves that your product is safe and effective, provides clinical benefit, and meets all applicable Essential Safety and Performance Requirements (ESPR) of the MDR. Errors or omissions often lead to inquiries from notified bodies and delays in the approval process.
Clinical evaluation as a central element:
- Mandatory requirement under Article 61 and Annex XIV of the MDR
- Methodically conducted according to MEDDEV 2.7/1 Rev. 4 and the relevant MDCG guidelines
- Strictly reviewed by the Notified Bodies – including using the MDCG 2020-13 checklist (Clinical Evaluation Assessment Report)
- closely linked to risk management (ISO 14971), PMS and 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 |
Would you prefer to write it yourself?
If you plan to conduct your clinical evaluation entirely or partially yourself and only want support where you need it, our Clinical Evaluation Guidance is the right solution.