Clinical Evaluation Written 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 to report.
You receive a clinical evaluation plan, systematic literature search, critical evidence appraisal, clinical evaluation report, and PMCF plan as a single package that withstands scrutiny.
Fixed project price and clear schedule – no hourly fees or surprises.
How to Proceed
Assessment of Current Evidence
Evaluation Plan (CEP)
Literature Search and Analysis
Finished CER
- No workload on your literature review
- No unfounded equivalence claims
- No gaps between evidence and intended use
What Does Clinical Evaluation Mean?
Clinical evaluation is a systematic and continuous process of collecting, assessing, and analyzing clinical data related to a device to determine whether the evidence sufficiently demonstrates its safety, performance, and acceptable benefit-risk profile. Requirements are defined by MDR Article 61 and Annex XIV. The outcome is the clinical evaluation report (CER), part of the technical documentation, updated continuously throughout the device lifecycle.
Systematic, Not One-off
The evaluation follows a defined process from planning to search, analysis, and reporting—not a selective sample from the literature.
Evidence Linked to Intended Use
Every claim about safety and performance must be supported by evidence specific to your device’s intended use.
Updated Throughout the Lifecycle
Market data, PMCF results, and new literature are regularly integrated into the evaluation.
Clinical evaluation is not a literature review but a reasoned conclusion on whether the evidence suffices for your device’s intended use.
We Do the Evaluation, You Don’t
Clinical evaluation requires regulatory expertise and the ability to critically assess scientific evidence. Few manufacturers have the resources for this. We handle the work; all we need from you is device information.
We create the clinical evaluation plan and define evidence requirements
We conduct a documented and repeatable literature search
We critically appraise the quality and relevance of evidence
We write the CER and identify gaps for the PMCF plan
You don’t need to learn search strategies or guess if the evidence suffices for the notified body.
What Clinical Evaluation Includes
Below are the steps every manufacturer must follow. Scope varies by device class and evidence situation, but the structure remains the same.
Scope Definition and CEP
The clinical evaluation plan (CEP) defines what will be evaluated and according to which criteria. It is the first document the assessor reads and guides the entire process.
- Intended use, indications, target population, and contraindications
- Claims about safety and performance and clinical endpoints
- Acceptance criteria for benefit-risk balance and sufficiency of evidence
Without clear acceptance criteria, conclusions cannot be justified.
Identification of Clinical Data
Data is collected from the device itself, equivalent devices, and treatment alternatives, including your own market data and complaints.
- Own clinical study data and market feedback
- Systematic literature search with documented strategy
- Incident and complaint data plus regulatory databases
The search strategy must be documented so the assessor can replicate it.
Justifying Equivalence
If evidence relies on another device, equivalence must be demonstrated technically, biologically, and clinically. MDR requirements are significantly stricter than the Directive.
- Technical, biological, and clinical comparison feature-by-feature
- Justification that differences have no clinical impact
- Adequate access to technical data of the comparator device
Equivalence is the most common reason MDR clinical evaluations fail assessment.
Evidence Assessment and Analysis
Each publication and data set is evaluated for methodological quality and relevance. Only then can evidence be weighted in conclusions.
- Inclusion and exclusion criteria plus documentation of selection
- Quality and relevance assessed by predefined criteria
- Evidence analyzed against claims and outcomes
Weak evidence need not be hidden—it must be openly assessed and weighted.
Clinical Evaluation Report (CER)
The CER compiles the process, evidence, and conclusions. It demonstrates the device achieves performance per intended use and that residual risks are acceptable relative to benefits.
- Conclusions on safety, performance, and benefit-risk ratio
- Links to risk management, GSPR matrix, and instructions for use
- Identified residual gaps and uncertainties
CER conclusions must be consistent with risk file and instructions for use.
PMCF and Update Cycle
Identified evidence gaps transfer to post-market clinical follow-up. The PMCF plan defines how these gaps will be closed and the update schedule.
- PMCF plan and methods to close gaps
- PMCF evaluation report and integration of results into reassessment
- Update frequency based on device class and risk level
Class III and implantable devices are reassessed at least annually.
We build these steps into a continuous chain where claim, evidence, and conclusion are traceable from start to finish.
What a Completed Clinical Evaluation Delivers
A well-done evaluation is not just a requirement but also the foundation for clinical claims and marketing.
Certification Progresses
Clinical evaluation is the most common bottleneck in notified body assessments – a robust CER clears it.
Fewer Requests for Additional Info
A documented search and justified evidence appraisal preemptively answer assessor questions.
Sustainable Clinical Claims
You know exactly what you can say about your device in sales and marketing without claims exceeding evidence.
The same documentation supports certification, marketing, and the next product development cycle.
Who is Our Clinical Evaluation Service For?
Our service is designed for manufacturers of medical devices and software who must demonstrate sufficient clinical evidence to a notified body or authority.
It is especially suitable when:
We support both startups certifying their first device and established manufacturers updating their CERs.
How We Prepare Your Clinical Evaluation
You don’t do the evaluation yourself as a project; we carry it out in clear stages. You always know what evidence has been found and what it means for your device.
Assessment and Planning
We review your device, intended use, and existing evidence and draft the clinical evaluation plan with acceptance criteria.
“Clear understanding of evidence requirements.”
Search, Appraisal, and Reporting
We conduct a systematic literature search, assess evidence quality and relevance, and write the clinical evaluation report.
“We write, you approve.”
Gaps, PMCF, and Evaluation Support
We identify residual gaps, prepare the PMCF plan, and assist you with notified body questions and additional information requests.
“Conclusions withstand scrutiny.”
We also agree on an update cycle so the evaluation stays current with PMCF results and new literature.
Most Common Errors in Clinical Evaluation
The same deficiencies repeat year after year. They are avoidable by planning the evaluation before starting searches.
Unjustified Equivalence
Relying on equivalence without technical, biological, and clinical comparison or without access to comparator device data.
Selective Literature
Including only positive publications without a documented search strategy and exclusion criteria.
Evidence Does Not Cover Intended Use
Clinical data relates to a different patient group, indication, or environment than the device’s intended use.
The assessor does not seek perfect evidence but honestly assessed and justified evidence.
Fixed Price, Predictable Project
We price clinical evaluation as a project based on device classification and evidence situation. You know the cost before work begins.
Fixed project price with no hourly fees
Clearly defined content and delivery schedule
Scope scaled to device risk classification
Updates and PMCF reporting arranged separately
You receive a quote specifying what will be done, in what timeframe, and at what cost.
Why MDRpankki?
We combine regulatory expertise and critical scientific evidence appraisal so your clinical evaluation withstands scrutiny.
Regulatory Expertise
We know MDR Article 61, Annex XIV, MEDDEV guidelines, and notified bodies’ practical expectations.
Methodology
Searches, inclusion criteria, and evidence appraisal are documented for reproducibility and verifiability.
Turnkey
We don’t sell hours but deliver a finished product: a clinical evaluation ready for assessment.
Your team focuses on the product; we handle the clinical evidence and its documentation.
Consult with an MDR Expert
Together we will assess the current status of your clinical evidence and what MDR specifically requires from your device.
Frequently Asked Questions about Clinical Evaluation
- Clinical evaluation is a systematic process of collecting and assessing clinical data related to a device to determine whether it sufficiently demonstrates safety, performance, and an acceptable benefit-risk profile. The clinical evaluation report (CER) is the outcome: a document describing the methods used, the evidence assessed, and the justified conclusion. CER is part of the technical documentation and is updated throughout the device lifecycle.
- Not always. Clinical studies are generally required for Class III and implantable devices, but MDR Article 61 allows exceptions, for example, when evidence is based on a well-justified equivalence. For other classes, evidence can consist of literature, equivalence, and market data. During assessment, we determine whether existing evidence suffices or if gaps need to be closed by studies or PMCF.
- Yes. This is the core of our service. We need information about your device, intended use, technical features, and existing data. We prepare the plan, conduct searches, assess evidence, and write the report. You review and approve the final product. Responsibility for compliance always remains with the manufacturer, so approval is yours.
- Update intervals are risk-based and documented in the clinical evaluation plan. Class III and implantable devices are updated at least annually. For other classes, intervals typically range from two to five years, but updates are required whenever PMCF results, incidents, new literature, or product changes warrant it.
- Equivalence must be demonstrated technically, biologically, and clinically, and the clinical irrelevance of differences justified. Additionally, the manufacturer must have sufficient access to the comparator device's technical documentation, which usually requires an agreement with its manufacturer if it is not the same product. This is significantly stricter than under the Directive and is the most common reason for rejecting equivalence justification.
- Typically from a few weeks to several months. The timeline depends on device risk class, amount of literature, and whether an existing evaluation is being updated or a new one created from scratch. After assessment, we provide an estimate of both schedule and scope before starting work.