The clinical evaluation is one of the most demanding requirements of EU MDR. Every device — regardless of class — must have a clinical evaluation that demonstrates safety and performance based on clinical data. Getting it right is critical for Notified Body approval.
EU MDR Article 61 and Annex XIV require every manufacturer to conduct a clinical evaluation to demonstrate that the device achieves its intended clinical purpose and that the residual risks are acceptable in light of the clinical benefits. This applies to all device classes.
The CEP defines the scope and methodology of the clinical evaluation before it is conducted. It identifies the intended purpose, target population, clinical claims, relevant standards and the clinical data sources that will be used to demonstrate conformity.
The CER documents the outcome of the clinical evaluation. It must demonstrate that sufficient clinical evidence exists to support the safety and performance claims for the device. For Class III and implantable Class IIb devices a Notified Body review is mandatory.
Where clinical data from the exact device is limited, manufacturers may use data from an equivalent device. EU MDR has strict equivalence criteria — technical, biological and clinical — that must all be met and documented with a formal equivalence assessment.
A systematic literature search is required to identify all relevant clinical data. The search must be documented with a reproducible protocol, search strings, databases searched, inclusion and exclusion criteria, and a PRISMA-style flow diagram.
We prepare a device-specific CEP defining intended purpose, clinical claims, equivalent devices where applicable, and the clinical data strategy to be followed.
We conduct a systematic literature search across PubMed, Embase and other relevant databases, appraise each study for relevance and quality, and document findings in a structured table.
We analyse available clinical data — from literature, clinical investigations, PMCF studies or equivalent device data — and assess whether it is sufficient to support your clinical claims.
We write the complete Clinical Evaluation Report in accordance with MEDDEV 2.7/1 Rev 4 and EU MDR Annex XIV, structured to meet Notified Body expectations.
Clinical evaluations must be updated regularly. We manage the annual CER update cycle incorporating new literature, PMCF data and post-market surveillance findings.
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