How Do You Write a Clinical Evaluation Plan?
A clinical evaluation plan (CEP) is essential for establishing the scope of the clinical evaluation. All medical devices marketed in EU member state countries must undertake a clinical evaluation. This is based on the General Safety and Performance Requirements of the Medical Device Regulation (EU 2017/745). Manufacturers will need to undertake a literature review for medical devices as part of the clinical evaluation requirements.
In this article, we’ll explore some of the fundamentals to include in a CEP and why they’re so important to meet the purpose of the MDR (the European Union Medical Device Regulation).
The CEP describes available data, such as in-house studies, safety and performance data, pre/ post-market clinical data, and published articles pertaining to the device being evaluated in order to assess whether the available data supports the clinical safety, performance, and benefit/risk profile of the target device(s) when used as intended and to support any claims made by the manufacturer.
A manufacturer of a product should define the scope of the clinical evaluation based on the General Safety and Performance Requirements (GSPR – Annex I, MDR) that need to be addressed in relation to the target product.
The CEP is intended to cover all clinical evidence data for demonstration of safety and performance of the device, whether favorable, unfavorable, or inconclusive. Through the CEP and CER, a manufacturer of a medical device must demonstrate that the intended purpose and claims made in relation to the safety and performance of a medical device are achieved. The amount of clinical information required will differ according to the history of a device or the device technology. If a product has a well-established technology, the clinical evaluation plan, and resulting clinical evaluation report will be developed accordingly.
Any deviations from the Clinical Evaluation Plan after its approval should be justified, appropriately documented, re-approved, and noted in the Clinical Evaluation Report.
The CEP should be updated every two years for class IIa devices and should be set out in a company procedure.
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What Should Be Included in a Clinical Evaluation Plan?
The CEP should describe the process to collect, review and analyze any relevant clinical or post-market surveillance data that is available or has become available since the previous CER.
The CEP should include the following information:
- An overview of the device(s), including a device description, intended purpose indications/contraindications, and operating procedures.
- Usability of the device for the intended users and the suitability of the information materials.
- Claims on product performance and safety.
- Clinical benefits.
- Risk management, including residual risks and measures for risk mitigation (if applicable).
- Consistency between any identified internal and external documents and the current knowledge/ the state-of-the-art.
- Details of literature search and database searches.
The CEP document and process are designed to meet the requirements as described in MEDDEV 2.7.1, ISO 14155; and the MDR (EU Regulation 2017/745 of the European Parliament and of the Council).
Internal data to allow assessment of the safety, performance, and risk/benefit profile of the target device should be presented in this section. Data should include
- Complaint data.
- Corrective and Preventive Action (CAPAs), including details and outcomes (if available) of any CAPAs.
Data should be reviewed from the risk analysis conducted for the product with reference to ISO 14971, Medical Devices – Application of Risk Management to Medical Devices. Internal risk analysis documents should be reviewed and evaluated and compared to the benefits of using the product.
Results of bench testing performed should be included in the CER to demonstrate the state-of-the-art safety and performance of the device.
Searches using national regulatory and vigilance databases must be conducted to determine the occurrence of any adverse events, safety notifications, product recalls, or deaths. A summary of the findings should be included in the main text of the CER and full details of any relevant data outputs should be provided as an Appendix to the CER.
A review of the findings from the clinical evaluation should be presented in the CER. The critical analysis of the clinical data must be performed to assess:
- The contents of information materials supplied by the manufacturer (including the label, IFU of the device, Investigator Brochure, and promotional materials – if applicable).
- The compliance with General Safety and Performance Requirements (GSPRs) of the product, and benefit/risk profile.
- The residual risks and uncertainties or unanswered questions to evaluate whether they are acceptable for CE-marking (their nature, probability, extent, duration, and frequency) and whether any PMS (Post market Surveillance) plans, including in particular PMCF (Post Market Clinical Follow-up) activities are required.
- Whether there are adequate data for all aspects of the intended purpose (such as indications and clinical benefits/ claims) and for all products/ models/ sizes/ settings covered by the Clinical Evaluation
- The identification of any gaps and discrepancies, any residual risks and uncertainties, or unanswered questions (such as rare complications, uncertainties regarding medium- and long-term performance, and safety under widespread use) that will require further evaluation during PMS activities, including in PMCF studies.
Each stage needs to show the milestones you’ll refer back to and the required criteria to meet approval.
Who Can Create a Clinical Evaluation Plan?
Regulators need to check whether a CEP has been prepared by suitably experienced individuals with the skills and knowledge to determine the value and relevance of clinical data. Therefore, you should check the guidelines before assigning responsibility for drafting a CEP.
A reviewer should have documented qualifications, including:
- An understanding of regulations and the specific technology.
- Awareness of research best practice and methodology.
- Medical writing experience.
- Comprehension of the conditions involved and how the device will manage or diagnose them.
A qualified reviewer or a medical writer with access to advanced literature review software will be well equipped to define the scope of a CEP and develop a plan that meets all regulatory standards.