The Clinical Evaluation Plan outlines the methods for developing and updating the Clinical Evaluation Report. This plan is revised as needed by post-market clinical follow-up, such as when new search criteria are added for literature searches.
Although the content of the Clinical Evaluation is straightforward, crafting it, determining an appropriate structure, and forming a logical justification for equivalence can be complex.
To write the Clinical Evaluation effectively, it is essential to review the following guidance documents:
- Regulation (EU) 2017/745 on Medical Devices
- MEDDEV 2.7/1 “CLINICAL EVALUATION”
- MDCG 2020-1 Guidance on Clinical Evaluation & Performance Evaluation of Medical Device Software
- MDCG 2020-5 Guidance on Clinical Evaluation – Equivalence
- MDCG 2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices
- MDCG 2020-13 Clinical Evaluation Assessment Report Template
- GHTF 2006 Clinical Evaluation
The following checklist provides an overview of relevant documents and information needed for clinical evaluation:
- Intended use
- Product description (including indications and contraindications)
- User instructions
- List of potential equivalent products (e.g., competitors, predecessor models)
- Competitor or predecessor model user instructions/marketing brochures
- Comparative analysis of equivalent products
- Information on alternative treatment methods
- List of marketing claims, particularly clinical claims
- Marketing brochures
- Risk management documentation (plans, analyses, reports, and annual reports)
- Usability files/user study reports
- PMS/PMCF plan
- PMS reports/PSUR
- Sales data for the product or predecessor (including the timeframe)
- Complaint handling data, including safety incident reports (with timeframe)
- Clinical study/trial reports
- Relevant preclinical studies or supporting safety and performance reports
- Checklist for general safety and performance requirements
- Previous clinical evaluations of the product or its predecessor
- List of relevant literature or guidelines
- Software test reports
1. Purpose and Scope
As outlined in Regulation (EU) 2017/745, Article 61 and Annex XIV, clinical performance, safety, and benefit assessments must be based on ‘clinical data’ and are mandatory for all medical device classes. The Clinical Evaluation Report and its supporting clinical data validate the clinical safety and performance of the
2. Definitions
| Term / Abbreviation | Description |
|---|---|
| MDR | Regulation (EU) 2017/745 |
| […] | […] |
3. Product Information
| Manufacturer: | |
| Product name: | |
| Product models: | |
| CE marking: | |
| Classification: |
Further details about the device, such as intended user group, indications, and contraindications, can be found in the document ISD – Intended Use (provide a reference).
4. Clinical Benefits
Outline the intended clinical benefits of the device.
The Clinical Evaluation Report will weigh the benefits of the device against associated risks, facilitating a complete benefit-risk assessment.
5. Clinical Claims
All claims regarding the
| No. | Claim | Source | Reference |
|---|---|---|---|
| 1 | |||
| … |
If there are no claims:
No claims need validation in the clinical evaluation.
6. Risk Management
A risk analysis, conducted in compliance with EN ISO 14971 for the
- SOP Risk management
- Risk Management Plan
- Risk Analysis
- Risk Management Report
The risk management plan/process outlines the methodologies used for assessing qualitative and quantitative aspects of clinical safety. Clinical data analysis will include any identified residual risks and side effects. Any hazards, risks, or side effects found in the Clinical Evaluation Report will be assessed in the risk management file. A thorough benefit-risk assessment will compare the identified risks with the device’s benefits.
7. Clinical Development Plan
Provide an overview of all clinical investigations that have been completed, are ongoing, or are planned for the near future.
If no studies have been conducted: Justify why clinical studies were not carried out for this device.
8. Clinical Evidence
Clinical evaluation is a continuous process that spans the life cycle of a Medical Device Software (MDSW). Both positive and negative data should be included in the technical documentation.
Clinical evidence will be compiled considering three main components:
Valid clinical association
Proving that the clinical situation, condition, indication, or parameter matches the intended purpose of the MDSW.
Technical performance
Demonstrating the MDSW’s capability to accurately, reliably, and precisely produce the intended output from the input data.
Clinical performance
Showing the MDSW’s ability to provide clinically relevant outcomes in line with its intended use.
9. Post-market Surveillance
The following databases will be used for searches:
- MHRA (Medicines and Healthcare products Regulatory Agency)
- Swissmedic
- BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)
- FDA MAUDE database
- FDA recall database
Additionally, a PMCF plan has been established as per MDR, Annex XIV Part B.