CER Writing & Remediation
Clinical Evaluation Report Writing and Remediation
For medical device teams that need a new, updated, or remediated Clinical Evaluation Report under EU MDR. We structure clinical evidence, state-of-the-art reviews, and benefit-risk conclusions in a way that is evidence-based and designed to support MDR review.
Who This Is For
When You Need CER Support
New CE marking application
You are bringing a device to market under EU MDR and need a CER written from a structured Clinical Evaluation Plan through to benefit-risk conclusions.
Legacy CER update
Your device was certified under MDD. The CER does not meet MDR requirements for SOTA benchmarking, evidence appraisal methodology, or benefit-risk structure.
CER remediation after NB comments
Your Notified Body has raised major or minor observations on the clinical evaluation. The CER needs targeted revision or full remediation to address the questions raised.
Annual CER update
Your CER is due for its annual review and update to reflect new PMS/PMCF data, literature, and any changes to the benefit-risk profile or device configuration.
What We Deliver
CER Deliverables
Every CER engagement produces documentation structured to meet the clinical evaluation requirements of EU MDR Annex XIV and MEDDEV 2.7/1 Rev. 4, reviewed against current MDCG guidance and Notified Body expectations.
Suitable for Class IIa, IIb, III, and implantable devices. We work with your classification and risk profile to define the appropriate clinical evidence standard.
Included
- Clinical Evaluation Plan — objectives, scope, equivalence strategy, SOTA definition
- State-of-the-art literature narrative with documented search methodology
- Clinical evidence summaries and critical appraisal by evidence type
- Benefit-risk analysis and conclusions aligned to SOTA and intended purpose
- Equivalence justification — technical, biological, and clinical pillars (where applicable)
- Cross-document consistency check against IFU, risk file, PMS, and PMCF
Our Approach
How We Write a CER
A defensible CER starts with documented methodology, not with writing. Most CER deficiencies flagged by Notified Bodies are methodology failures — not evidence failures. We address the methodology first.
Clinical Evaluation Plan
We define scope, objectives, equivalence strategy, SOTA search methodology, and evidence appraisal criteria before writing begins. The CEP is the foundation of a defensible CER — not an afterthought.
State-of-the-Art Review
We conduct a systematic literature review with a prespecified search strategy, documented to satisfy Notified Body expectations for audit trails and reproducibility.
Clinical Evidence Appraisal
We stratify and appraise evidence by source — manufacturer clinical data, literature, post-market data — with clear quality assessment and weighting rationale for each source.
Benefit-Risk Writing
We write benefit-risk conclusions grounded in appraised clinical evidence, aligned to SOTA, and connected to residual risks, claims, and intended purpose.
Cross-Document Alignment
We check that the completed CER is consistent with the IFU, risk management file, PMS plan, and PMCF plan. Inconsistencies are flagged and resolved before final delivery.
Related Services
A completed CER typically connects to post-market documentation and, if NB questions arise, to a structured response package.
Ready to discuss your CER?
Tell us your device class, current documentation status, and timeline — we will help identify the right starting point.