Medical Devices

What Is a Clinical Evaluation Plan?

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When you write a clinical evaluation plan (CEP), you create the starting point and guiding document behind the clinical evaluation of a medical device. This sets out how you will define the scope of the evaluation, and the process for recording and measuring the outcomes.

A clinical evaluation is a complex task and requires a clear road map to ensure the process reaches a verifiable conclusion. Therefore, the CEP creates a methodical approach to identify the required activities and how they will be carried out. Standardizing an approach to the clinical evaluation within the clinical evaluation plan will ensure that research activities are carried out in a purposeful manner and will increase the likelihood of generating a successful report.

What Is the Purpose of a Clinical Evaluation Plan?

The point of creating a CEP is to steer a clinical evaluation while accurately recording each step. This ensures compliance with the EU MDR and includes the literature search protocol for medical devices that applies to any clinical data researched, cited, or analyzed.

A CEP will cover a range of points and processes, such as:

  • The safety and performance specifications for the device
  • Which metrics require clinical data support
  • How you will evaluate the clinical data
  • Information of the device, its expected outcomes, and target user groups
  • Indications or contraindications for device usage

Data is key because the CEP must explain the plan and show how you will identify the relevant clinical data, how you’ll appraise it, and what the outcome of that analysis will mean. CEPs can include several data sources, but they need to be used in a defined, structured, and systematic way to ensure clarity and compliance.

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What Is a Clinical Evaluation Report?

A clinical evaluation report (CER) is a document produced later down the line that records the outcomes of the clinical evaluation. The CER contains evidence that a medical device manufacturer has conducted a thorough clinical evaluation and that the results prove their device is safe and effective for its intended use.

Contents of a CER

A clinical evaluation has three phases:

  1. The manufacturer identifies relevant clinical data extracted from literature, clinical trials, or experiences–or all three.
  2. An appraisal of the quality, significance, and relevance of the data and how it applies to this specific evaluation is created.
  3. Conclusions are drafted that explain how they have been reached and how they rely on the data used.

A CER is required to secure CE markings for all medical devices to be sold in the EU, as it serves as legal evidence that the product has achieved sufficient environmental, health, and safety standards.

Can I Produce a CER Without a CEP?

These tasks go hand in hand–you can’t proceed with a CER without a CEP to guide the evaluation approach. A CEP isn’t the medical evaluation itself–it is the document that sets out how the review will be conducted. In fact, to achieve MDR approval, manufacturers need to create three documents, which are the:

  • Clinical Development Plan (CDP)
  • Clinical Evaluation Plan (CEP)
  • Clinical Evaluation Report (CER)

The first step–the CDP–serves as the foundation for the next two stages and shows the research strategy behind a medical device or treatment and identifies an overall blueprint for the program, its development, and project resources. Any one report cannot exist without the others, so a full medical evaluation must be backed by sufficient evidence and methodology from the outset.

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