A Clinical Evaluation Plan, or CEP, defines how a manufacturer will identify, appraise and analyse the clinical data needed to demonstrate the safety, performance and clinical benefits of a medical device under Regulation (EU) 2017/745.
The CEP is prepared before the clinical evaluation is completed. It establishes the scope, methods, evidence requirements, acceptance criteria and clinical-development strategy. The results of that work are subsequently documented in the Clinical Evaluation Report, or CER.
This guide provides a practical working structure based on MDR Article 61 and Annex XIV. It is not an official European Commission template and must be adapted to the device, intended purpose, risk classification, lifecycle stage and clinical-evidence strategy.
What Is a Clinical Evaluation Plan?
A Clinical Evaluation Plan is the documented strategy for planning and maintaining the clinical evaluation of a medical device throughout its lifecycle.
Under MDR Annex XIV, the manufacturer must establish and regularly update the CEP. The plan should explain what clinical evidence is required, where that evidence will come from, how it will be appraised and analysed, and how remaining evidence gaps will be addressed.
A generic table of contents is not sufficient. The CEP must remain consistent with the intended purpose, Instructions for Use, clinical claims, risk-management documentation, General Safety and Performance Requirements, PMS activities and PMCF strategy.
CEP vs CER vs Clinical Development Plan
| Document | Purpose | What it should contain |
|---|---|---|
| Clinical Evaluation Plan | Defines how the clinical evaluation will be conducted and maintained. | Scope, evidence requirements, sources, appraisal methods, analysis methods, acceptance criteria and update strategy. |
| Clinical Evaluation Report | Documents the results and conclusions of the completed clinical evaluation. | Identified data, appraisal results, analysis, evidence gaps, benefit-risk conclusions and demonstration of conformity. |
| Clinical Development Plan | Defines how clinical evidence will be generated over time. | Progression from exploratory to confirmatory investigations and PMCF, with milestones and acceptance criteria. |
Manufacturers generally need both a CEP and a CER. The Clinical Development Plan forms part of the CEP but may also be maintained as a supporting document when the programme is complex.
For a detailed evidence-generation structure, use our Medical Device Clinical Development Plan under MDR to define activities, milestones, acceptance criteria and PMCF.
Our guide to the MDR Clinical Evaluation Report explains how the evidence identified and analysed under the CEP is documented in the final CER.
Mandatory CEP Content under MDR Annex XIV
Annex XIV, Part A, Section 1 requires the Clinical Evaluation Plan to address at least the following elements:
1. Applicable GSPRs
Identify the General Safety and Performance Requirements that require support from relevant clinical data.
2. Intended purpose
Define the medical purpose, intended users, patient population, use environment and other conditions of use relevant to the clinical evaluation.
3. Target groups, indications and contraindications
Specify the intended patient groups and the clinical conditions for which the device is and is not intended.
4. Intended clinical benefits
Describe the expected clinical benefits and define the clinical outcome parameters used to measure them.
5. Clinical safety
Specify the methods used to examine qualitative and quantitative aspects of clinical safety, including residual risks and undesirable side effects.
6. Benefit-risk parameters
Define the parameters and acceptance criteria used to determine whether the benefit-risk ratio is acceptable for each indication and intended purpose, considering the current state of the art.
7. Device-specific benefit-risk considerations
Explain how issues associated with medicinal substances, non-viable animal or human tissues, or other relevant components will be addressed.
8. Clinical Development Plan
Describe the planned progression from exploratory investigations to confirmatory investigations and PMCF, including milestones and potential acceptance criteria.
These are minimum regulatory elements. A usable CEP normally needs additional sections for document control, responsibilities, data-identification methods, appraisal criteria, equivalence, PMS inputs and update triggers.
Clinical Evaluation Plan Template: Practical Working Structure
| Section | Information to include |
|---|---|
| 1. Document control and approvals | CEP title, device, Basic UDI-DI where available, manufacturer, version, date, authors, reviewers, approvers and revision history. |
| 2. Purpose and scope | Purpose of the CEP, devices and variants covered, lifecycle stage, regulatory pathway and relationship with previous CEPs and CERs. |
| 3. Device description | Device design, components, materials, operating principle, classification, variants, accessories and relevant technical characteristics. |
| 4. Intended purpose and clinical claims | Intended purpose, indications, contraindications, patient population, intended users, use environment, clinical benefits and claims requiring clinical evidence. |
| 5. GSPR and risk-management interface | GSPRs requiring clinical support, identified hazards, residual risks, undesirable side effects and links to the risk-management file. |
| 6. State of the art | Clinical background, alternative treatments, benchmark devices, relevant guidelines and accepted safety and performance parameters. |
| 7. Required level of clinical evidence | Amount and quality of evidence needed, with justification based on device characteristics, risk, intended purpose and claims. |
| 8. Clinical-data identification strategy | Databases, search concepts, date ranges, manufacturer-held data, clinical investigations, PMS, PMCF, vigilance, registries and other relevant sources. |
| 9. Data-appraisal methodology | Criteria for relevance, methodological quality, scientific validity, applicability and contribution to the clinical evaluation. |
| 10. Data-analysis methodology | Methods for combining and interpreting evidence, addressing conflicting results, evaluating safety and performance and reaching benefit-risk conclusions. |
| 11. Equivalence strategy | Proposed equivalent device, technical, biological and clinical characteristics, access to relevant data and justification for using equivalence. |
| 12. Clinical Development Plan | Existing evidence gaps, planned investigations, milestones, acceptance criteria and connection with pre-market and post-market evidence generation. |
| 13. PMS and PMCF interface | PMS and PMCF inputs, signals and uncertainties to be monitored, and how new data will feed into the clinical evaluation. |
| 14. Update strategy | Planned review frequency and event-driven triggers such as design changes, new claims, new risks, vigilance signals, PMCF results or changes in the state of the art. |
| 15. Responsibilities, deviations and annexes | Responsible functions, review and approval process, deviations from the plan, references, search protocols, appraisal tools and supporting matrices. |
This structure is a working template, not an official prescribed format. Manufacturers may combine or separate sections, provided that the mandatory MDR content remains complete, traceable and specific to the device.
The CEP should describe the planned analysis methods and acceptance criteria. Actual search results, appraisal outcomes and final clinical conclusions belong in the CER.
How to Prepare the CEP in Five Steps
Step 1. Confirm the Device Scope and Regulatory Inputs
Define exactly which devices, variants, accessories, intended purposes and claims the CEP covers.
Reconcile this information with the Instructions for Use, labelling, risk-management file, GSPR checklist, technical documentation and previous clinical-evaluation documents before establishing the evidence strategy.
Step 2. Define the Clinical Questions and Evidence Requirements
Translate the intended purpose, clinical benefits, risks and claims into specific clinical questions.
Define the safety and performance parameters, clinical outcome measures, benchmark values and acceptance criteria that will be used to evaluate the evidence.
Step 3. Plan Identification, Appraisal and Analysis
Specify all clinical-data sources and the methods used to identify them. The approach may include manufacturer-held data, systematic literature searches, clinical investigations, PMS, PMCF, vigilance information, registries and relevant data concerning equivalent devices.
Define the appraisal criteria before reviewing the evidence. Explain how relevance, methodological quality, scientific validity and applicability will be assessed.
PRISMA, PICO or related frameworks may improve transparency where appropriate, but they are methodological tools rather than universal MDR requirements.
Step 4. Connect Evidence Gaps to Clinical Development and PMCF
Explain how gaps identified through the clinical-evidence strategy will be addressed.
The Clinical Development Plan should connect each material gap or uncertainty with an evidence-generation activity, milestone and acceptance criterion. This may include feasibility work, confirmatory clinical investigations, observational studies, registries or PMCF activities.
Step 5. Approve, Maintain and Update the Plan
Define who authors, reviews and approves the CEP and which events require reassessment.
The update schedule should reflect the device’s risk, maturity and rate of evidence generation. It should also include event-driven triggers such as design changes, new indications, revised claims, new risks, vigilance signals, PMCF findings or changes in the state of the art.
The MDR does not establish one universal annual update interval for every CEP. The manufacturer should justify a device-appropriate schedule and maintain alignment between the CEP, CER, PMS, PMCF and risk-management documentation.
How MDCG 2020-6 Applies to Legacy Devices
MDCG 2020-6 addresses the clinical evidence needed for devices previously CE marked under the MDD or AIMDD. It should not be presented as a general replacement for MDR Annex XIV.
For legacy devices, Appendix II provides additional considerations for the CEP, including:
- alternative treatment options;
- a strategy for identifying and appraising all available clinical data;
- equivalence evidence where applicable;
- justification of the required level of clinical evidence;
- systematic use of PMS and PMCF data;
- treatment of complaints, vigilance information and previously identified evidence gaps.
Appendix III provides a suggested hierarchy of evidence. This hierarchy can support appraisal, but it does not remove the need to evaluate the relevance, quality and scientific validity of each data source.
How MEDDEV 2.7/1 Rev. 4 Should Be Used
MEDDEV 2.7/1 Rev. 4 was developed under the former Medical Device Directives. It remains useful for several scientific and methodological aspects of clinical evaluation, but it is not an MDR legal requirement in its entirety.
MDCG 2020-6 identifies the sections that remain relevant under the MDR. These include guidance on defining the scope of the evaluation, assessing scientific validity, appraising data and maintaining consistency with the intended purpose, labelling, claims and risk-management documentation.
Where MEDDEV and the MDR differ, the MDR takes precedence.
Common CEP Mistakes
Frequent problems include:
- using a generic template without adapting it to the device and its claims;
- documenting completed analysis and conclusions in the CEP instead of the CER;
- failing to define the required level of clinical evidence;
- omitting measurable clinical benefits or acceptance criteria;
- using an outdated state-of-the-art assessment;
- treating MDCG 2020-6 as if it applied only or identically to every device;
- claiming equivalence without a complete technical, biological and clinical assessment;
- failing to connect evidence gaps with the Clinical Development Plan or PMCF;
- allowing the intended purpose, IFU, risk-management file and clinical documentation to become inconsistent;
- updating the CER without reviewing whether the CEP also needs revision.
Clinical Evaluation Plan Review Checklist
Before approving the CEP, confirm that:
- The device, variants and intended purpose are unambiguous.
- Clinical claims are mapped to evidence requirements.
- Applicable GSPRs requiring clinical data are identified.
- Clinical benefits have measurable outcome parameters.
- Safety and performance criteria are defined.
- Benefit-risk acceptance parameters reflect the current state of the art.
- Data sources and literature-search methods are documented.
- Data-appraisal criteria are defined in advance.
- Analysis methods explain how conflicting or incomplete evidence will be handled.
- Equivalence is fully planned and justified where used.
- Evidence gaps are connected to clinical development or PMCF activities.
- Update frequency and event-driven triggers are specified.
- The CEP aligns with the IFU, claims, risk-management file, PMS plan and PMCF plan.
- Authors, reviewers, approvals and version control are complete.
MDx CRO supports medical device manufacturers with Clinical Evaluation Plans, Clinical Evaluation Reports, systematic literature reviews, clinical-evidence gap assessments, equivalence strategies and PMCF planning.
Explore our Regulatory Affairs and Technical Documentation services or contact our regulatory team to discuss a new or existing device.
Frequently Asked Questions
Yes. MDR Annex XIV requires manufacturers to establish and regularly update a Clinical Evaluation Plan as part of the clinical-evaluation process.
No. The CEP defines how the clinical evaluation will be conducted. The CER documents the evidence identified, its appraisal and analysis, and the resulting conclusions.
Yes. The planning stage is documented in the CEP, while the results and supporting clinical evidence are documented in the CER.
The MDR defines the minimum content but does not prescribe one universal document format. MDCG 2020-6 Appendix II provides additional content considerations for legacy-device CEPs.
There is no single update interval suitable for every device. The manufacturer should define a justified schedule and review the CEP when the device, intended purpose, risks, claims, clinical evidence or state of the art changes.
No. A Clinical Evaluation Plan applies to medical devices under the MDR. IVDs require a Performance Evaluation Plan under IVDR Annex XIII. Although the documents share planning principles, their regulatory requirements and evidence categories are different.
