Medical Device Clinical Evaluation Report (CER)
The Clinical Evaluation Report is one of the most scrutinized documents in a medical device technical file, assessed by a Notified Body at every certification and renewal cycle. It must satisfy EU MDR (2017/745) Annex XIV and demonstrate that the device's benefit-risk profile is acceptable on sufficient clinical evidence. EvySaif prepares the full clinical evaluation, from the plan through the report, for devices of every risk class.
Clinical evaluation is a continuous process
Under MDR Article 61 and Annex XIV Part A, clinical evaluation is an ongoing process, required for all risk classes, even Class I. The MDR defines what must happen; MEDDEV 2.7/1 Rev 4, with MDCG documents such as 2020-6 and 2020-5, explains how, and Notified Bodies still benchmark against that methodology.
Scope and plan
A compliant evaluation starts with a Clinical Evaluation Plan (CEP), part of the technical documentation, which defines the scope, the state of the art, and the clinical evidence strategy.
Identify and appraise the data
Pertinent clinical data, both data generated by the device and data from an equivalent device, is identified and appraised for quality and relevance. The literature review must be systematic, following a pre-specified protocol with search terms and inclusion and exclusion criteria set before any results are reviewed.
Justify equivalence, or generate data
Where equivalence to another device is claimed, it must be justified against MDCG 2020-5. Where direct clinical data is needed and does not yet exist, a clinical investigation under ISO 14155 becomes necessary, and for implantable and Class III devices it is generally required.
Report, then keep it live
The analysis against the intended purpose is documented in the Clinical Evaluation Report, which connects forward to Post-Market Clinical Follow-up (PMCF) under Annex XIV Part B to keep the CER current over the device lifetime.
When a study is required: where existing data is insufficient to demonstrate conformity, and generally for implantable and Class III devices, a clinical investigation under ISO 14155 is needed. We design that protocol too.
What we prepare
CEP and CERClinical Evaluation Plan and Clinical Evaluation Report to MDR Annex XIV.
Systematic literature workSearch protocols and literature review reports, reproducibly documented.
Equivalence justificationsAligned with MDCG 2020-5 where equivalence is claimed.
State of the art and benefit-riskState-of-the-art analysis and benefit-risk documentation.
Clinical development strategyFor higher-risk devices where new data is needed.
PMCF feeding the CERPMCF plans and reports that keep the CER current, plus Annex XIV gap analysis.
How EvySaif helps
We prepare the full clinical evaluation, from the plan through the report, for devices of every risk class. Our literature reviews are systematic and reproducible, equivalence is justified to MDCG 2020-5, and the CER connects forward to the post-market obligations Notified Bodies expect to see joined up.
Why EvySaif
EvySaif ranks among the best research and medical writing consultancies in India, and our systematic-review discipline is exactly what a defensible CER depends on. Our clinician-led evaluations appraise clinical relevance correctly, document the search so it is reproducible, and connect the CER to the post-market obligations Notified Bodies now expect to see joined up.
Frequently asked questions
Yes. A clinical evaluation and CER are required for all risk classes under the MDR, including Class I devices, though the depth of evidence scales with risk.
Yes. Although it dates from the previous Directive, it remains the methodology Notified Bodies benchmark against, used together with MDR Annex XIV and relevant MDCG guidance.
When existing data is insufficient to demonstrate conformity, and generally for implantable and Class III devices. It is conducted under ISO 14155.
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