Clinical Evaluation Report (CER) Preparation

Clinical Evaluation Report (CER) specialist

Build Trust with Scientific Evidence: MDR-Compliant Clinical Evaluation

For every medical device carrying the CE mark in the European Union, preparing an up-to-date, scientifically sound Clinical Evaluation Report (CER) is mandatory under the Medical Device Regulation (MDR). This report demonstrates your device's safety and performance through clinical data, building trust with Notified Bodies and competent authorities.

At Şah Grup, we stand by you at every stage of CER preparation — from literature review to equivalence assessment, from Post-Market Clinical Follow-up (PMCF) planning to the integrity of the final report — bringing your device's clinical file into full alignment with regulatory expectations.

Our Comprehensive Clinical Evaluation Consulting Services

We offer a service model covering every step required for an MDR-compliant, scientifically sound CER:

1. Clinical Data Collection and Analysis

We systematically compile and analyze the data set that will support your device's clinical safety and performance.

Literature Review: Comprehensive review of scientific publications, clinical studies and case reports on your device and similar technologies.
Clinical Experience Data: Incorporating post-market reports, registry data and clinical usage outcomes into the evaluation.
Manufacturer Data Collection: Integrating your own clinical investigations, test results and field data into the evaluation process.
Data Quality Assessment: Rigorously examining the collected data for scientific validity and reliability.

2. Equivalence Assessment and Literature Review

Where direct clinical data is unavailable, we apply the equivalence approach prescribed by the MDR with scientific rigor.

Clinical Equivalence Analysis: Identifying and comparatively assessing products that can be considered technically, biologically and clinically equivalent to your device.
Systematic Literature Review Methodology: Conducting a reproducible, transparent review process with predefined search criteria and inclusion/exclusion criteria.
Evidence Appraisal: Scoring the weight of the evidence found and its contribution to the clinical evaluation using scientific criteria.

3. PMCF (Post-Market Clinical Follow-up) Planning

We plan and manage post-market clinical follow-up processes so that the CER remains a living document, kept continuously up to date.

Post-Market Clinical Follow-up Plan: Preparing a PMCF plan compliant with MDR requirements to monitor your device's performance under real-world conditions of use.
Periodic Safety Update Reports (PSUR): Reporting safety and performance data at intervals appropriate to the device's risk class.
CER Update Cycle: Regularly integrating new clinical data and PMCF findings into the Clinical Evaluation Report.

Why Şah Grup?

Strategic Approach:

We treat the CER not as a one-off document, but as a living evidence file that is updated throughout your product's life cycle.

International Expertise:

With a team well-versed in the MDR's clinical evaluation requirements and Notified Body expectations, we prepare scientifically sound reports.

Single-Point Solution:

We manage the entire clinical evaluation process on your behalf, from literature review to PMCF planning.

Up-to-Date Expertise:

By closely tracking updates to MDR guidance documents and Notified Body expectations, we keep your reports current at all times.

Take the first step to strengthen your device's clinical file with scientific evidence today. Get in touch with us to meet our expert team and build a roadmap tailored to your CER process.