Clinical Evaluation Scope

Within the Clinical Evaluation Plan (CEP), the “Clinical Evaluation Scope” chapter is to precisely define the boundaries, depth, and focus of the current clinical evaluation activities. A clear and comprehensive scope definition ensures that the clinical evaluation comprehensively covers all regulatory requirements and key clinical questions, while also preventing it from becoming overly broad or deviating from its central objectives. This approach facilitates an efficient and accurate assessment of the safety and performance of the device under evaluation.

The drafting of this chapter should aim to clearly communicate to all relevant parties (including internal teams, Notified Bodies, etc.) what the evaluation will encompass, based on what considerations, and how it will be conducted.

Defining the Device Under Evaluation and Its Core Context

The definition of the clinical evaluation scope begins with a clear identification of the core subject of the evaluation. The specific name of the medical device targeted by this clinical evaluation, along with the models, sizes, or series it covers (if applicable), needs to be explicitly stated.

Subsequently, the device’s current lifecycle stage should be elucidated. For instance, whether it is a new device seeking initial CE marking, an evaluation of a significant change to a marketed device, or a re-evaluation of a mature “legacy device” according to MDR requirements. Different lifecycle stages naturally entail different emphases in the evaluation and varying depths of required evidence.

Furthermore, if the device under evaluation incorporates any design features requiring special attention (e.g., use of innovative materials, inclusion of medicinal substances, materials of animal or human origin), specific intended uses or indications (e.g., for a rare disease, or use in a specific high-risk procedure), or is intended for particular target patient populations (such as children, pregnant women, or immunocompromised individuals), these must be highlighted within the scope. Such aspects often necessitate more targeted data collection and risk assessment strategies.

Articulating Evaluation Objectives and Key Claims

The scope of the evaluation must be closely aligned with the intended use of the device under evaluation and the various clinical claims made by the manufacturer. These key claims regarding the device’s safety, clinical performance, and intended clinical benefits should be clearly listed or summarized.

Concurrently, the scope section should specify which relevant General Safety and Performance Requirements (GSPRs) this clinical evaluation aims to demonstrate conformity with, particularly GSPR 1 (regarding the device achieving its intended purpose and being safe and effective) and GSPR 8 (regarding clinical evaluation requirements), as well as other GSPRs relevant to the device type and characteristics.

Defining the Extent of Reliance on Data Sources and Strategy

The scope of the clinical evaluation needs to clearly map out which data sources will be relied upon and how this data will be utilized.

• Consideration of the Equivalence Pathway (if applicable): If the clinical evaluation plans to follow an “equivalence” pathway with one or more marketed devices, this scope section should reaffirm this strategy. It needs to briefly reiterate which device(s) are considered equivalent and explicitly state that assessing the continued appropriateness of this equivalence claim itself falls within the scope of this clinical evaluation. Additionally, it should confirm whether sufficient high-quality clinical data is available from these equivalent device(s) to support the clinical claims for the device under evaluation.
• Application of State-of-the-Art (SOTA): It must be clearly defined how the current state-of-the-art (SOTA) will be established and applied as a benchmark for the evaluation. This includes identifying relevant clinical conditions and their natural course, existing standard treatment modalities (covering other benchmark devices, alternative therapeutic technologies, etc.), and all applicable international/harmonized standards and industry guidance documents. A significant aspect of the clinical evaluation is to compare and measure the safety and performance of the device under evaluation against this SOTA backdrop.
• Integration with Risk Management: The scope needs to explicitly describe how the clinical evaluation will systematically address the various clinical risks identified during the risk management process. The core is to confirm, through clinical data, that all residual risks are at an acceptable level when considering the device’s intended benefits and the current SOTA. Furthermore, the clinical evaluation also aims to verify the actual incidence rates of known risks or to identify potential new risks not previously discovered, using the collected clinical evidence.
• Planned Data Types and Sources: An overview of the specific types of data planned for retrieval, screening, and inclusion in the analysis during the clinical evaluation should be provided. It includes:
  • Preclinical data: E.g., manufacturer’s internal bench testing, animal studies, biocompatibility assessments, supporting the device’s basic safety, performance, and conformity to relevant standards.
  • Published scientific literature: Clinical studies, case reports, systematic reviews, etc., concerning the device under evaluation itself (if available) or similar/equivalent devices.
  • Clinical investigation data: If clinical investigations are ongoing or have been completed for the device under evaluation, their data will naturally be core evidence.
  • Post-Market Surveillance (PMS) data: Including user complaints, adverse event reports, vigilance data, literature monitoring, user feedback, etc.
  • Adverse event database information: Adverse event reports related to similar types of devices obtained from national regulatory agency databases or specialized professional databases.

Addressing Changes and Newly Emerging Clinical Considerations

The definition of the clinical evaluation scope also needs to be forward-looking and adaptable.

• If the device under evaluation has undergone any relevant changes in its design, manufacturing process, intended use, labeling, or instructions for use compared to previous versions (if any) or during its development, the scope must include an assessment of the potential clinical impact of these changes. For a completely new device, the focus will be on the specific evaluation needs arising from its innovative features.
• The scope should also encompass an ongoing process to actively identify and evaluate any newly emerging clinical safety or performance concerns related to the device, its analogues, or associated technologies. This information may originate from the latest scientific literature, warnings from regulatory authorities, opinions from professional societies, or be captured through PMS activities.

Linkage with Post-Market Surveillance (PMS) Activities

Clinical evaluation is not a one-time event; its findings are closely linked with Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF). Therefore, the scope should consider:

• How the conclusions of this clinical evaluation will provide input and guidance for ongoing PMS activities (particularly the development or adjustment of the PMCF plan).
• How future Clinical Evaluation Report (CER) updates will systematically incorporate new PMS data, PMCF results, and any evolution in the SOTA to ensure the continued validity and timeliness of the clinical evaluation.