Clinical evaluation prepared for you
Clinical evaluation is the most demanding part of MDR documentation and the most common reason for notified body requests for additional information. We prepare it for you, from planning through to the report.
You receive a clinical evaluation plan, systematic literature search, critical appraisal of evidence, clinical evaluation report and PMCF plan as one complete package that stands up to assessment.
Fixed project price and clear schedule - you know the cost before work begins.
How it works
Assessment of the current evidence base
Evaluation plan (CEP)
Literature search and analysis
Completed CER
- No in-house literature workload
- No unjustified equivalence
- No gaps between evidence and intended purpose
What does clinical evaluation mean?
Clinical evaluation is a systematic and ongoing process of collecting, appraising and analysing clinical data relating to a device, and assessing whether it is sufficient to demonstrate the device's safety, performance and acceptable benefit-risk ratio. Article 61 and Annex XIV of MDR define the requirements. The outcome is a clinical evaluation report (CER), which forms part of the technical documentation and is updated throughout the device life cycle.
Systematic, not a one-off exercise
The evaluation follows a defined process from planning through searching, analysis and reporting - not a selective sample of literature.
Evidence linked to intended purpose
Every safety and performance claim must be supported by evidence that corresponds specifically to your device's intended purpose.
Updated throughout the life cycle
Information gathered from the market, PMCF results and new literature feed back into the evaluation at agreed intervals.
Clinical evaluation is not a literature review, but a justified conclusion on whether the evidence is sufficient for your device's intended purpose.
We carry out the evaluation, not you
Clinical evaluation requires both regulatory expertise and the ability to critically appraise scientific evidence. Few manufacturers have dedicated resources for this. We do the work for you and only need information about your device from you.
We prepare the clinical evaluation plan and define the evidence requirements
We conduct a documented and reproducible literature search
We critically appraise the quality and relevance of the evidence
We write the CER and identify gaps for the PMCF plan
You do not need to learn search strategies or guess whether the evidence is sufficient for the notified body.
What clinical evaluation includes
Below are the stages every manufacturer must go through. The scope varies according to device class and the evidence available, but the structure remains the same.
Defining the scope and CEP
The clinical evaluation plan (CEP) defines what is assessed and against which criteria. It is the first document an assessor reads and guides the entire process that follows.
- Intended purpose, indications, target population and contraindications
- Safety and performance claims, and clinical outcome parameters
- Acceptability criteria for the benefit-risk ratio and sufficiency of evidence
Without clear acceptability criteria, the conclusion cannot be justified.
Identifying clinical data
Data is gathered both from the device itself and from equivalent devices and treatment alternatives. It also includes the manufacturer's own information gathered from the market and complaints.
- Own clinical investigation data and data gathered from the market
- Systematic literature search with a documented search strategy
- Incident and complaint data, as well as authority registers
The search strategy must be recorded so that the assessor can reproduce the search.
Justifying equivalence
If the evidence relies on another device, equivalence must be demonstrated technically, biologically and clinically. MDR significantly tightened the requirements compared with the Directive era.
- Technical, biological and clinical comparison feature by feature
- Justification that differences have no clinically significant impact
- Sufficient access to the technical documentation of the equivalent device
Under MDR, equivalence is the most common reason why a clinical evaluation does not withstand assessment.
Appraisal and analysis of evidence
Each included publication and data source is assessed for methodological quality and relevance. Only then can the evidence be weighted in the conclusions.
- Inclusion and exclusion criteria, and documentation of selection
- Assessment of quality and relevance using predefined criteria
- Analysis of evidence in relation to claims and outcome parameters
Weak evidence does not need to be hidden - it must be appraised and weighted transparently.
Clinical evaluation report (CER)
The CER brings together the process, evidence and conclusions. It demonstrates that the device achieves the performance intended for its intended purpose and that residual risks are acceptable in relation to the benefits.
- Conclusion on safety, performance and the benefit-risk ratio
- Links to risk management, the GSPR matrix and instructions for use
- Identified residual gaps and uncertainties
The CER conclusion must be consistent with the risk management file and instructions for use.
PMCF and update cycle
Identified evidence gaps are transferred to post-market clinical follow-up. The PMCF plan sets out how gaps will be closed and on what schedule the evaluation will be updated.
- PMCF plan and methods for closing gaps
- PMCF evaluation report and feedback of results into the evaluation
- Update interval based on device class and risk level
The evaluation of Class III and implantable devices is updated at least annually.
We build these stages into one traceable chain, where the claim, evidence and conclusion can be followed from start to finish.
What a completed clinical evaluation delivers
A well-prepared evaluation is not only a requirement, but also the foundation for your product's clinical claims and marketing.
Certification progresses
Clinical evaluation is the most common bottleneck in notified body assessment - a robust CER removes it.
Fewer requests for additional information
A documented search and justified appraisal of evidence address the assessor's questions in advance.
Robust clinical claims
You know what you can say about your device in sales and marketing without the claim exceeding the evidence.
The same material supports certification, marketing and the next version of product development.
Who is our clinical evaluation service for?
Our service is intended for manufacturers of medical devices and software who need to demonstrate the sufficiency of clinical evidence to a notified body or authority.
It is particularly suitable when:
We help both startups certifying their first device and established manufacturers whose CER is due for an update.
How we prepare your clinical evaluation
You do not have to manage the evaluation as a project yourself. We take it through clear stages. At all times, you know what evidence has been found and what it means for your device.
Assessment and planning
We review your device, intended purpose and existing evidence, and prepare a clinical evaluation plan with acceptability criteria.
“A clear view of the evidence requirements.”
Search, appraisal and report
We conduct a systematic literature search, assess the quality and relevance of the evidence, and write the clinical evaluation report.
“We write, you approve.”
Gaps, PMCF and assessment support
We identify residual gaps, prepare a PMCF plan and support you with notified body questions and requests for additional information.
“A conclusion that stands up to scrutiny.”
We also agree on an update cycle, so that the evaluation remains current as PMCF results and new literature become available.
The most common mistakes in clinical evaluation
The same shortcomings recur in evaluations year after year. They can be avoided by planning the evaluation before searches begin.
Unjustified equivalence
Equivalence is relied on without technical, biological and clinical comparison, or without access to the equivalent device documentation.
Selective literature
Only favourable publications are included, without a documented search strategy or grounds for exclusion.
Evidence does not cover the intended purpose
The clinical data concerns a different patient group, indication or use environment than the device's own intended purpose.
The assessor is not looking for perfect evidence, but for evidence that has been honestly appraised and justified.
Fixed price, predictable project
We price clinical evaluation as a project based on the device classification and evidence situation. You know the cost before work begins.
Fixed project price for the agreed scope
Clearly defined scope and delivery schedule
Scope tailored to the device risk class
Updates and PMCF reporting agreed separately
You receive a quotation showing what will be done, by when and what it will cost.
Why MDRpankki?
We combine regulatory expertise with scientific evidence appraisal, so your clinical evaluation also stands up to a critical reader.
Regulatory expertise
We know MDR Article 61, Annex XIV and MEDDEV guidance, as well as notified body expectations in practice.
Methodological rigour
Searches, inclusion criteria and evidence appraisal are documented so that they can be reproduced and reviewed.
Turnkey delivery
We take responsibility for the outcome, not merely the hours worked: a clinical evaluation ready for assessment.
Your team focuses on the product; we take care of the clinical evidence and its documentation.
Speak with an MDR expert
Together, we will assess the current state of your clinical evidence and what MDR requires specifically from your device.
Frequently asked questions about clinical evaluation
- Clinical evaluation is a systematic process of collecting and appraising clinical data relating to a device, and assessing whether it is sufficient to demonstrate safety, performance and an acceptable benefit-risk ratio. The clinical evaluation report, or CER, is the final output of the process: a document describing the method used, the evidence assessed and the justified conclusion. The CER is part of the technical documentation and is updated throughout the device life cycle.
- Not always. A clinical investigation is generally required for Class III and implantable devices, but Article 61 of MDR allows exceptions, for example where the evidence is based on sufficiently justified equivalence. In other classes, evidence may consist of literature, equivalence and data gathered from the market. During the assessment, we determine whether existing evidence is sufficient or whether gaps remain that must be closed through an investigation or PMCF.
- Yes. That is the core of our service. We need information from you about the device, intended purpose, technical characteristics and existing material. We prepare the plan, conduct the searches, appraise the evidence and write the report. You review and approve the outcome. Responsibility for conformity always remains with the manufacturer, so the final approval is yours.
- The update interval is determined on a risk-based approach and recorded in the clinical evaluation plan. Evaluations for Class III and implantable devices are updated at least annually. For other classes, the typical interval is two to five years, but the evaluation must always be updated when PMCF results, incidents, new literature or product changes give reason to do so.
- Equivalence must be demonstrated technically, biologically and clinically, and the lack of clinical significance of any differences must be justified. In addition, the manufacturer must have sufficient access to the technical documentation of the equivalent device, which in practice requires an agreement with that device's manufacturer if it is not your own product. This is clearly stricter than under the Directive and is the most common reason for equivalence justifications to be rejected.
- Typically, from a few weeks to a few months. The schedule is affected by the device risk class, the volume of literature and whether an existing evaluation needs updating or the documentation is prepared from scratch. After the assessment, we provide an estimate of both the schedule and scope before work begins.
What is clinical evaluation and what is a CER?+
Do we need our own clinical investigation?+
Can you prepare the clinical evaluation entirely for us?+
How often must a clinical evaluation be updated?+
What does demonstrating equivalence require under MDR?+
How long does it take to prepare a clinical evaluation?+
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