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MDR Clinical Evaluation Plan (CEP) for Medical Devices
Clinical Evaluation Plan is a road map for conducting the clinical evaluation process. It includes the scope, methodological, and systematic approach on how to proceed and reach a conclusion on the clinical evaluation, to document it in a clinical evaluation report. The Clinical Evaluation Plan is the first and the principal document to be prepared. It gives stepwise planning for the activities to be carried out. This plan helps to continuously guide and document a clinical evaluation.
A CEP is a structured document that outlines how a medical device will be clinically evaluated. It is a critical part of the clinical evaluation documentation as per the new MDR 2017/745. Chapter VI, Article 61 of the EU MDR details the relevant aspects to be considered for the critical evaluation of the clinical data that support the GSPR. Towards the end of clause no. 1 has indicated the planning, conducting, and documenting of the clinical evaluation. Annex XIV, Part A specifically explains the details to be covered in the CEP.
A poorly written CEP can cost you months of delays. Get it right the first time with I3CGlobal’s MDR Clinical experts. View pricing or request a free quote today.
Requirements for a Clinical Evaluation Plan
The MDR annex XIV part A, section 1(a), the Clinical Evaluation Plan (CEP) is a mandatory requirement, not just guidance as in MEDDEV 2.7/1 Rev 4. The CEP must clearly define how clinical evidence will be generated and evaluated to demonstrate compliance with the General Safety and Performance Requirements (GSPR). This means you have to clearly identify which GSPRs really need clinical evidence and explain how you will prove them. You also need to describe the device properly its intended use, who will use it (target patients), the medical condition it is meant for (indications), and when it should not be used (contraindications). The expected clinical benefits should not be vague; they must be written as simple, measurable outcomes so that anyone reviewing the document can easily understand and verify them.
At the same time, the CEP should clearly explain how you will check if the device is safe and works properly during its whole life. This means you need to show how you will find any risks or side effects, and how you will decide if the benefits are greater than the risks. You should also compare your device with current treatments or similar devices to prove that it is safe and useful.
The CEP should also explain where your data will come from. This could be from your own device, similar (equivalent) devices, published studies, or clinical investigations. It should also explain how you will compare your device with the current standard of care (state of the art). If the device contains any medicines or special materials, you must explain how their safety will be checked. You also need to decide how much clinical evidence is required based on how risky the device is. Another important part is the Clinical Development Plan (CDP), which shows the full plan from early testing to bigger studies and then post-market follow-up (PMCF) after the device is on the market.
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Clinical Evaluation Plan Consultants and Clinical Writers
Clinical evaluation plan consultants and writers from I3CGlobal are highly sought after for their expertise in the development of CEP due to several reasons.
- Our expertise in MDR Technical Documentation and clinical evaluations can ensure that the Clinical evaluation plan meets these requirements, reducing the risk of Notified Body rejections or major non-conformity.
- Our experience in Clinical Study Design including selecting appropriate endpoints, sample sizes, and statistical methods can help ensure that the study is well-designed and can provide meaningful results.
- Our knowledge of Medical Devices and their clinical applications allows us to provide valuable insights into the clinical evaluation process.
- Hiring the I3CGLOABL team adds Efficiency and cost Effectiveness can be more cost-effective than hiring a full-time employee, especially for smaller companies or projects that do not require a full-time clinical evaluation team.
- The experience and expertise of the I3CGLOABL team can provide faster results in the clinical evaluation process, which can be valuable for companies that may be too close to the project end due to major issues identified by Notified Bodies.
- I3CGLOBAL has access to the best global network of experts and resources that can be valuable for conducting the clinical evaluation, such as clinical trial sites, CROs, regulatory agencies, and other agencies to conduct post-market clinical follow-up etc.
- Clinical Evaluation Consultants can help identify and mitigate potential risks in the clinical evaluation process, reducing the likelihood of issues arising during regulatory review.
Overall, hiring a CER Consultant for the development of a clinical evaluation plan and the creation of necessary templates and records can offer numerous benefits to companies in the medical device manufacturing industry.
Based on MEDDEV 2.7/1 Rev. 4 and MDR article 61 prescribed format, our team of experts has developed a MDR clinical evaluation plan template covering all the requirements. Manufacturers or their regulatory personnel can buy from us online. Suitable for Small and Medium sized companies with less Regulatory professionals
Basic Requirements for a structured and well-organized Clinical Evaluation Plan
Clinical evaluation plan play a crucial role in the CER documentation as per article 61 and MEDDEV 2.7.1 Rev 4 by providing a structured approach. A Plan typically includes the following requirements:
- Identification of general safety and performance requirements (Annex I of MDR) that require the support of the clinical data.
- The intended purpose of the device.
- Intended target groups with indications and contraindications.
- Varied aspects are required for the analysis and the conformity assessment of the clinical data.
- Intended clinical benefits with relevant and specified clinical outcome criteria.
- Methods to be used for the evaluation of qualitative and quantitative details of clinical safety concerning the determination of residual risks and side effects.
- Identify and specify the criteria to be used to determine the acceptability of the benefit-risk ratio for various indications and the intended purpose of the device, based on state –of –art.
- If any specific components such as the use of medicinal substances, or non-viable animal or human tissues are incorporated into the medical device, then how to address the related benefit-risk must be identified.
- Indication of the technique followed for the collection of clinical data for the clinical evaluation (equivalent device data or the device under evaluation data or the scientific literature).
- A clinical development plan with an indication of the progress from an exploratory investigation to a confirmatory investigation and a post-market clinical follow-up with a clear indication of the milestone and description of potential acceptance criteria for each progression.
- Level of clinical evidence required for the demonstration of the conformity assessment of the general safety and performance requirement.
The Clinical Evaluation Plan should be identified in the technical documentation. The CEP can be presented in an easily identifiable way either as a separate document or as part of the clinical evaluation report.
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Follow MEDDEV 2.7/1 Rev.4 Guidance Document for early Clinical Evaluation Plan Approval
MEDDEV 2.7/1 Rev. 4 is the guidance document for performing the clinical evaluation of medical devices before CE marking and after the CE marked stage. This guidance provides a stage-wise explanation of the clinical evaluation where Stage 0 points out the scoping and the planning which specifies the contents as given below:
- Device description.
- Intended purpose, Target group, an indication that requires any attention for safety and performance.
- The specific application of the device targets the treatment group and disease proposed warnings, contraindications, precautions, and method of application.
- Specific claims made by the manufacturer about clinical safety & performance.
- Residual risk has clinical significance.
- Relevant standards and guidelines available for the current knowledge and state of art, available medical alternatives for the target population.
- Source of data and types of data to be used in clinical evaluation.
- All the above aspects need to be covered for both (a) before CE Marking and (b) already CE Marked for medical devices.
- Information needed for evaluation of equivalence, if it is claimed has also been considered for the before CE marking devices.
Who can create a good Clinical Evaluation Plan?
Not everyone can write a Clinical Evaluation Plan that actually holds up. You need people who have spent real time working with clinical data, who understand European medical device regulations inside out, and who can put it all together in writing that’s clear, structured, and review-ready.
The technical knowledge matters, but so does the judgment; knowing which data is relevant, how to present a benefit-risk argument, and where Notified Bodies tend to push back. That kind of experience only comes from doing this work repeatedly, across different device types and regulatory contexts.
At I3CGlobal, that’s what our team brings to the table. We’ve written, reviewed, and templated CEPs across a wide range of devices always built around Article 61 and Annex XIV of EU MDR 2017/745. Our goal is simple: a CEP that doesn’t come back with a list of major findings.
If you’re starting fresh or just want a second set of experienced eyes on what you already have, we’d love to help. Reach out for a free quote and let’s take it from there.
Serious note for Legacy Device manufactures while making Clinical Evaluation Plan
For legacy medical devices, the Clinical Evaluation Plan plays a crucial role in ensuring that the devices comply with current EU Medical Device Regulation (MDR) requirements, especially for devices previously placed on the market under the Medical Devices Directive (MDD). Key considerations for legacy devices in the CEP are the following
- Identify areas where additional clinical data may be needed, such as safety, performance and PMS data and update the Clinical Evaluation Plan accordingly
- A clear and robust equivalence justification must be provided, as MDR requirements are much stricter than MDD in legacy device
- The plan should include the outcome of the risk-benefit analysis under MDR standards and ensure a favorable risk-benefit profile
- The Clinical Evaluation Plan for legacy devices must be updated periodically
- Integrate a robust PMS plan and a PMCF plan into the CEP, in line with Article 61 of MDR
Frequently Asked Questions: Clinical Evaluation Plan for Medical Devices
How to address deviations in the Clinical Evaluation Plan?
Any deviations from the Clinical Evaluation Plan after CER is signed off should be justified and appropriately intimated to the notified body during the next surveillance audit. The CEP should be updated every two years for class IIa and other low-risk devices and the higher class should be updated every year.
What are the main MDR of the Clinical Evaluation Plan?
- The Clinical Evaluation Plan needs to identify the General safety and performance requirement that requires clinical data
- The intended purpose of the medical device
- Intended target groups, clear indications and contra-indications
- Intended clinical benefits to patients with relevant and specified clinical outcome parameters
- Methods used for qualitative and quantitively aspects of clinical safety to determine residual risk/side effects
- Parameters to be used to determine State of the Art and acceptability of benefit/risk for all indications
- Benefit-risk issues relating to specific components such as use of pharmaceutical, non-viable animal or human tissues
Is the Clinical evaluation plan for Legacy Device is different?
No exemption is allowed for legacy devices
MDCG 2020-6 Appendix II provides the minimum information expected for legacy device Clinical Evaluation Plan.
How Important documenting the clinical benefit
MDR requires that manufacturers describe the intended clinical benefits to patients in the Clinical Evaluation Plan and it must align with the intended purpose. The below questions answer clinical writers have to document in CER
- How does the use of the device improve the health of the patient?
- What is the positive outcome of using the device, from the perspective of the patient?
Page updated on 12th May 2026 by Sara Moly and Approved by Dr. Anjali V. Bhatt