Expert CER / Clinical Evaluation Report Consulting Services

A clinical evaluation report, or CER, is a formal regulatory document that assesses the clinical safety, performance, and benefit-risk profile of a medical device. It compiles and analyzes relevant clinical data, published literature, post-market information, and risk management outputs to demonstrate that the device meets applicable regulatory requirements, especially under EU MDR and MEDDEV 2.7/1 Rev. 4.

A CER typically requires a clear device description, intended purpose, state-of-the-art review, clinical background, literature search methodology, appraisal of relevant data, analysis of safety and performance, benefit-risk conclusions, and alignment with risk management and post-market evidence. Under EU MDR, the report must be systematic, traceable, scientifically justified, and kept current throughout the device lifecycle.

Medical device manufacturers seeking CE marking or maintaining EU MDR compliance commonly need CER support. This includes startups preparing first submissions, established manufacturers updating legacy documentation, and companies responding to Notified Body findings. Devices with limited clinical evidence, changing intended use, or higher-risk classifications often benefit from expert CER consulting to strengthen defensibility.

A CER should be updated whenever new clinical data, post-market findings, design changes, labeling changes, or regulatory developments affect the device's clinical evaluation. Higher-risk devices and actively marketed products generally require more frequent review. Regular updates help ensure the CER remains aligned with PMCF, PMS, complaint trends, and current risk management conclusions.

Yes. Elexes can assess an existing CER for methodological weaknesses, outdated literature, unsupported equivalence claims, inconsistent benefit-risk conclusions, and poor alignment with risk management or PMS data. The remediation process focuses on closing evidence gaps, improving traceability, strengthening scientific rationale, and bringing the report closer to current EU MDR and Notified Body expectations.

A strong CER should not stand alone. It must align with ISO 14971 risk management outputs, residual risk justifications, complaint and PMS trends, and PMCF planning or results. Regulators expect consistency across these documents. When the CER, RMF, and post-market evidence tell the same evidence-based story, the overall submission becomes more coherent and credible.

Elexes supports a wide range of medical device manufacturers, including conventional devices, SaMD, IVD-related programs, implantables, wearables, diagnostics, and combination products. The team has experience across more than 200 product types, allowing CER development and review to be tailored to the device classification, evidence profile, intended use, and target market requirements.

Outsourcing CER writing gives manufacturers access to experienced regulatory and clinical documentation professionals without adding permanent headcount. It can improve report quality, reduce internal bottlenecks, strengthen literature methodology, and help avoid costly submission delays caused by weak evidence narratives or inconsistent documentation. It also supports faster remediation when timelines are tight.