Clinical evaluation is a cornerstone of medical device compliance under the EU Medical Device Regulation 2017/745 (MDR). The MDR has significantly raised the bar for clinical evidence, requiring manufacturers to demonstrate safety, performance, and clinical benefit through a systematic and continuously updated process. For many devices, particularly those transitioning from the MDD, this has resulted in increased scrutiny of clinical data quality, relevance, and traceability.
A well-constructed Clinical Evaluation Report (CER) is no longer a static document prepared solely for initial certification. Under the MDR, clinical evaluation is an ongoing lifecycle activity, closely linked to risk management, post-market surveillance, and device claims. For startups, scale-ups, and SMEs with limited clinical or regulatory resources, meeting these expectations can be challenging. MD Compliance supports manufacturers in developing robust, MDR compliant clinical evaluation plans and reports that stand up to Notified Body review and support long-term market access.
A clear and well-defined Clinical Evaluation Plan (CEP) is required to provide the foundation for a defensible clinical evaluation. The CEP defines the scope, methodology, and data sources that will be used to demonstrate conformity with the General Safety and Performance Requirements (GSPRs) and to support device claims.
The MD Compliance team has worked on over 250 Clinical Evaluation projects in recent years and we supports clients in developing MDR-compliant CEPs tailored to device type, classification, and risk profile. We help define clinical objectives, intended purpose, and relevant safety and performance endpoints, and establish clear criteria for data identification, appraisal, and analysis. Our CEPs are designed to be practical and proportionate, while remaining fully aligned with MDR requirements, MDCG guidance, and current Notified Body expectations.
MD Compliance provides end-to-end support for the development and maintenance of Clinical Evaluation Reports. We support both the preparation of new MDR-compliant CERs and the remediation or update of existing CERs originally developed under the MDD. For legacy devices, this often includes structured gap assessments to identify where additional data, analysis, or justification is required to meet MDR requirements.
Our CER development process considers all relevant clinical data sources, including clinical investigations, post-market clinical follow-up (PMCF) studies, post-market surveillance data, vigilance and complaint records, and scientific literature. Where equivalence is claimed, we support robust equivalence justification in line with MDR requirements, or we will advise on alternative clinical strategies where equivalence is no longer appropriate.
We focus on producing CERs that are coherent, evidence-based, and clearly structured, with transparent traceability between data sources, risk management, GSPRs, and device claims. Our reports are written with Notified Body review in mind, helping reduce questions, non-conformities, and avoidable rework.
While the Clinical Evaluation Report is a defined requirement under the EU MDR, robust clinical evaluation is also increasingly important in other regulatory markets, including the United States. MD Compliance supports clients in preparing clinical evaluation documentation tailored to non-EU regulatory frameworks, ensuring that clinical evidence is structured and presented in a way that meets local expectations.
In the US, clinical evaluation principles underpin FDA decision-making for 510(k), De Novo, and PMA submissions, supporting claims of safety, effectiveness, and substantial equivalence. Well-structured clinical evaluations can be critical for justifying intended use, supporting performance claims, addressing clinical risk, and informing benefit–risk assessments, particularly for novel technologies, software as a medical device, and devices without clear predicates. By aligning clinical evidence across global markets, we help manufacturers reduce duplication, strengthen submissions, and build a coherent clinical strategy that supports international market access.
Under the MDR, the CER must be fully integrated with post-market surveillance (PMS), PMCF, and the wider technical documentation. Regulators expect clinical evaluation conclusions to be actively maintained and supported by real-world data throughout the device lifecycle.
MD Compliance supports clients in aligning CERs with PMS and PMCF plans, risk management files, and other elements of the technical documentation. We help ensure that clinical data gaps are identified early, post-market activities are appropriately designed to address them, and that updates to clinical evaluation are triggered in a controlled and documented manner. This integrated approach supports ongoing compliance and simplifies future external assessments and renewals.
