CEP & CER Consulting for Medical Devices
Qserve combines former Notified Body reviewers, clinical specialists, and medical writers to build CEPs and CERs that hold up to scrutiny.
Why work with Qserve on clinical evaluation
Why work with Qserve on clinical evaluation
Qserve prepares clinical evaluation documentation across multiple device classes and therapeutic areas, including legacy devices, novel technologies, and combination products. Our team pairs clinical and regulatory experts with dedicated medical writers, so your documents are written to the standard your auditor expects.
We begin by reviewing your existing evidence and intended purpose followed by conducting the systematic literature appraisal, data analysis, and writing needed to deliver a CER that stands on its own. Where gaps exist, we identify them early and build a realistic plan to close them through either literature, or additional post-market clinical follow-up data.
What does the EU MDR require for clinical evaluation?
Under EU MDR (Regulation 2017/745), every medical device must be supported by an ongoing clinical evaluation. Article 61 and Annex XIV require manufacturers to plan, gather, and continuously appraise clinical evidence showing the device meets the relevant General Safety and Performance Requirements (GSPRs) and that its benefit-risk profile is acceptable.
For most manufacturers, the challenge is not whether a CER is needed, but how to produce one that is genuinely defensible: a realistic clinical strategy, a current literature base, and a clear thread linking intended purpose, clinical claims, and the evidence behind them.
What is the difference between a CEP and a CER?
A Clinical Evaluation Plan (CEP) is the strategy document: it defines the scope, clinical questions, methodology, and acceptance criteria before any appraisal begins. A Clinical Evaluation Report (CER) is the outcome: it documents the evidence gathered against that plan and demonstrates the device meets the relevant GSPRs. Under EU MDR, a CER is only robust if it is built on a sound, pre-defined CEP.
What are the stages of a clinical evaluation?
A clinical evaluation under EU MDR runs through five documented, traceable stages:
- Scoping: Define the device, its intended purpose, indications, clinical claims, and the GSPRs requiring clinical support.
- Planning (CEP): Establish the clinical strategy, methodology, data sources, and acceptance criteria.
- Identification of data: Conduct systematic literature searches and gather clinical, pre-clinical, PMS, and PMCF data relevant to the device.
- Appraisal: Critically assess the relevance, quality, and contribution of each data set against the pre-defined criteria.
- Analysis & reporting (CER): Synthesize the evidence, confirm the benefit-risk profile, and document conclusions in the Clinical Evaluation Report.
How ready is your Clinical Evaluation?
Weaknesses at any one of these stages tend to surface late, at Notified Body review, when they are most expensive to fix. Our Clinical Evaluation readiness check asks six questions across all five and returns a prioritized list of what to close first. About two minutes, results immediately.
How Qserve supports your clinical evaluation:
Clinical Evaluation Plan (CEP)
We define the scope, clinical strategy, methodology, clinical claims, outcome parameters and acceptance criteria in a CEP that provides your evaluation with a defensible foundation and a roadmap your auditor will recognize.
Systematic Literature Review
We design and execute reproducible, well-documented literature searches and appraisals in line with MDR expectations and MEDDEV / MDCG guidance.
Clinical Evaluation Report (CER)
We write or update your CER, synthesizing all available evidence into a clear, traceable benefit-risk conclusion aligned with Annex XIV and the GSPRs.
Gap Analysis & Remediation
We review existing documentation against current MDR and MDCG requirements, identify weaknesses, and prioritize the actions needed to close them..
PMCF & Lifecycle Integration
We connect your CER to your PMCF and post-market surveillance, so evidence is gathered with purpose and update cycles stay on schedule.
Post-Market Clinical Follow-up Plan
We prepare a PMCF-plan that outlines the methods and procedures for pro-actively gathering and evaluating clinical data in the post-market phase.
What causes a CER to fail Notified Body review?
What causes a CER to fail Notified Body review?
A clinical evaluation treated as a last-minute documentation exercise rarely survives Notified Body review. The most common, avoidable causes of failure are:
- Literature searches that are not reproducible or have gone out of date
- Equivalence claims that cannot be substantiated to the MDR standard
- A discrepancy between the device's intended purpose, its claims, and the evidence presented
- Insufficient justification of the benefit-risk determination
- A CER that is not maintained on a defined update cycle
Each of these can trigger non-conformities, certification delays, and expensive rework. A structured, well-planned clinical evaluation is the most reliable way to avoid them and to keep your certification timeline predictable.
At Qserve, we bring the regulatory insight and clinical writing expertise needed to turn clinical evaluation from a compliance risk into a competitive strength. We understand what Notified Bodies expect because our team has sat on the other side of the review. Working from proven methodologies and a deep medtech specialism, we structure your CEP, conduct rigorous appraisal, and deliver a CER that is defensible, well-documented, and ready for audits.
At Qserve, we bring the regulatory insight and clinical writing expertise needed to turn clinical evaluation from a compliance risk into a competitive strength. We understand what Notified Bodies expect because our team has sat on the other side of the review. Working from proven methodologies and a deep medtech specialism, we structure your CEP, conduct rigorous appraisal, and deliver a CER that is defensible, well-documented, and ready for audits.
Still have questions?
Is a clinical evaluation mandatory under the EU MDR?
Yes. Clinical evaluation is required under Article 61 and Annex XIV of Regulation (EU) 2017/745 for all medical devices, regardless of class. It is not a one-time exercise: the CER must be actively maintained throughout the device's lifecycle, with update frequency driven by the device's risk class and the volume of incoming post-market and PMCF data.
Can I use equivalence instead of leveraging my own clinical data?
Equivalence remains possible under the MDR, but the bar is significantly higher than under the previous Directive. You must demonstrate equivalence across technical, biological, and clinical characteristics, and for implantable and Class III devices, you generally need a contract giving full access to the comparator's technical documentation. Notified Bodies scrutinize equivalence claims closely, so we assess early whether equivalence is realistic. Your own clinical and PMCF data will be required from the onset.
How does the CER connect to PMCF and post-market surveillance?
Clinical evaluation is a closed loop. Gaps identified in the CER drive the PMCF plan; the data generated by those PMCF activities then feed back into the next CER update. A well-constructed CEP makes these links explicit, so post-market evidence is collected with a clear purpose rather than as a compliance afterthought.
How often does a CER need to be updated?
There is no single fixed interval. Under the EU MDR, the CER must be updated on a defined cycle, proportionate to the device's risk class and the flow of post-market and PMCF data: typically at least annually for implantable and Class III devices, and at least every 2 to 5 years for lower-risk devices. New safety signals, PMCF findings, or changes to the device or its claims can trigger an earlier update.
Relevant blogs
CEP and CER are not the same document. Learn the critical difference between a Clinical Evaluation Plan and Report under EU MDR, and why it matters.
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Discover the 5 top reasons Clinical Evaluation Reports fail MDR review, and what your team must do to get it right the first time.
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As experienced clinical evaluation writers, we see patterns that repeatedly trigger questions from reviewers. Read more for examples!