Clinical evaluation report MDR services
IASON supports medical device manufacturers in preparing and reviewing Clinical Evaluation Reports in accordance with MDR (EU 2017/745) and MEDDEV 2.7/1 Rev. 4.
MDR-compliant structure and documentation
CER creation, review, and gap analysis
Support for Class I, IIa, IIb, and III devices
Preparation for Notified Body assessment
Where manufacturers often need support
Insufficient clinical evidence
Missing or weak state of the art analysis
Incomplete equivalence justification
Inconsistencies across technical documentation
Rudimentary clinical strategy
Our focus is a structured, regulatorily sound CER that fits the overall technical documentation and supports a smoother review process.
The challenge
In practice, many CERs require targeted updates to align with current expectations, as recurring deficiencies can trigger additional questions, prolong review cycles, or result in non-conformities during conformity assessment.
Typical gaps
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Insufficient clinical evidence or weak justification of available data
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Limited integration of PMS and PMCF information
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Unclear linkage between risk management, claims, and clinical evidence
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Gaps in literature search methodology or appraisal
Potential consequences
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Additional rounds of questions from the Notified Body
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Internal delays caused by repeated document revisions
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Higher workload shortly before submission deadlines
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Increased regulatory risk during MDR transition or renewal
Our services
We provide tailored support depending on the maturity of your documentation, your internal resources, and the stage of your project.
CER Creation
End-to-end preparation of CERs for medical devices.
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Structured according to MDR, MDCG and MEDDEV 2.7/1 Rev. 4
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Integration of clinical, literature, and PMS data
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Aligned with device claims and intended purpose
CER Review & Gap Analysis
Detailed review of existing CERs with actionable feedback.
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Identification of compliance gaps
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Prioritized recommendations for remediation
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Support for document improvement before submission
Literature Review
Systematic literature search and documentation aligned with regulatory expectations.
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Search strategy design
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Screening and appraisal of relevant publications
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Traceable documentation of results
Equivalence Assessment
Support in assessing and documenting equivalence where applicable.
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Evaluation of available evidence
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Identification of limitations and regulatory risks
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Structured justification approach
Our approach
Our experienced regulatory experts work in a structured and transparent way, with clear responsibilities and close alignment to your device documentation and regulatory strategy.
1
Initial assessment
End-to-end preparation of CERs for medical devices.
2
Gap analysis
Identifying missing elements, inconsistencies, and compliance risks.
3
Execution
Preparation or revision of the CER and related justifications.
4
Quality review
Internal checks for consistency, completeness, and regulatory alignment.
5
Submission support
Assistance with questions and feedback rounds if required.
What you can expect
Our support is designed to reduce friction in the review process and strengthen the overall consistency of your technical documentation.
Clear and structured documentation
CERs that are aligned with regulatory expectations and fit into the broader technical file.
Reduced regulatory risk
Fewer avoidable gaps and a stronger basis for internal review and external assessment.
Efficient collaboration
A focused project setup with transparent deliverables and practical communication.
Support across device classes
Experience with Class I, IIa, IIb, III as well as active, implantable and Software as a Medical Device (SaMD) across different therapeutic areas.
Experience
We support manufacturers in different project settings, from first-time MDR submissions to remediation of existing documentation.
21
Years of experience
220
clients globally
490
Clinical evaluations prepared
Discuss you clinical evaluation requirements
If you are preparing a CER MDR submission, updating an existing CER, or responding to review findings, we would be glad to discuss the next steps with you.
IASON consulting offers free initial consultation to understand your situation and identify the most suitable support model.
