Medical device clinical evaluation goes beyond regulatory documentation—it supports the evidence behind your device’s safety and performance. Sobel helps manufacturers translate MDR clinical requirements into clear strategies, structured documentation, and defensible regulatory outcomes.
Under the EU MDR (2017/745), medical device clinical evaluation is mandatory for both achieving and sustaining CE marking, playing a key role in regulatory acceptance and long-term market access in Europe.
In the European Union, medical device clinical evaluation is a mandatory requirement for obtaining and maintaining CE marking under the EU MDR (2017/745).
Clinical evaluation is a core MDR requirement to demonstrate safety, performance, and clinical benefit throughout the device lifecycle.
When clinical evidence is not clearly planned, documented, or justified, gaps are often identified during Notified Body review, leading to additional questions and delays.
A compliant Clinical Evaluation is essential to demonstrate safety, performance, and clinical benefit under the EU MDR—and to support a smooth CE marking process.
Our services support manufacturers at different stages—from early planning to document updates and targeted regulatory support. You can request targeted support activities or an end-to-end clinical evaluation approach, depending on your device’s stage, available data, and regulatory strategy.
An end-to-end clinical evaluation solution covering both planning and final reporting. This approach supports a consistent and streamlined clinical evaluation pathway aligned with MDR expectations.
Identification of gaps between existing clinical data and MDR clinical evaluation requirements. This service supports early decision-making and helps avoid late-stage regulatory surprises.
Structured literature search planning, execution, and reporting to support clinical evaluation, state-of-the-art analysis, and equivalence claims. This includes search strategy definition, systematic review, and documented results aligned with MDR expectations.
Targeted support for responding to Notified Body questions, clarification requests, and deficiencies related to clinical evaluation documentation. This service focuses on strategic analysis and defensible responses, with document updates performed in coordination with the manufacturer.
Not sure which service best applies to your device? Sobel’s experts can help you define the most appropriate clinical evaluation pathway based on your device, data availability, and regulatory context.
The CEP and CER process is complex and closely linked to other MDR requirements. Sobel also supports manufacturers with the following complementary services:
Gap analysis, technical documentation, and ongoing regulatory for CE Mark for Medical Devices.
EAR for medical devices, supporting regulatory oversight and access to the EU market.
Expert biological evaluation services. BEP, BER, Gap analysis, and regulatory support.
A well-executed medical device clinical evaluation supports both CE marking and long-term regulatory acceptance in Europe. Sobel provides structured guidance and documentation support to align clinical evidence with MDR requirements.
1. Are CEP and CER mandatory for all medical devices in Europe?
Yes. Under the EU MDR (2017/745), all medical devices placed on the European market must be supported by a Clinical Evaluation. The Clinical Evaluation Plan (CEP) and the Clinical Evaluation Report (CER) are key elements of this process, with scope and depth varying according to the device’s risk class, intended purpose, and available clinical evidence.
2. What is the difference between a Clinical Evaluation Plan (CEP) and a Clinical Evaluation Report (CER)?
The CEP defines how the clinical evaluation will be conducted, including scope, methodology, data sources, and evaluation strategy. The CER documents the results of that process, providing a critical analysis of clinical evidence to demonstrate safety, performance, and clinical benefit under the EU MDR.
3. Can a CER be prepared without a CEP?
In principle, the CEP should always precede the CER. The CEP provides the structured framework required to ensure the CER is consistent, transparent, and defensible. Notified Bodies increasingly expect a clear, documented CEP to support the clinical evaluation process.
4. Do Class I devices also require CEP and CER?
Yes. Even for Class I devices, manufacturers must demonstrate compliance with MDR clinical evaluation requirements. While the evaluation is typically less complex, a documented CEP and CER are still required to justify safety and performance.
5. Does clinical evaluation always require clinical studies?
Not necessarily. Clinical evaluation is a risk-based process. Depending on the device and available evidence, published literature, equivalence data, and post-market information may be sufficient. Sobel supports manufacturers in assessing available data and identifying whether additional clinical studies are necessary, recommending new studies only when existing evidence cannot adequately support safety and performance claims.
6. How do Notified Bodies assess CEP and CER during conformity assessment?
Notified Bodies review whether the clinical evaluation strategy is appropriate, evidence is sufficient, and conclusions are scientifically justified. Common issues include weak equivalence claims, inconsistent methodology, and lack of alignment between CEP, CER, and other technical documentation.
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