1. Overview
This checklist is used to verify the completeness and consistency of the Clinical Evaluation Report against the requirements outlined in Appendix A10 of the MEDDEV 2.7/1 revision 4 Guideline.
Note: This checklist is sourced from Appendix A10 of the MEDDEV 2.7/1 revision 4 Guideline.
This template serves as a baseline to ensure compliance with the initial CE-marking requirements and highlights the primary elements that EU notified bodies will assess in your Clinical Evaluation Report. You may add or modify rows in the checklist as needed for your Software as a Medical Device (SaMD). Be sure to complete this checklist before moving forward with other technical documentation related to your SaMD, including post-market surveillance and risk assessment activities.
2. Related Documents
- Clinical Evaluation Report (Doc-ID)
3. Checklist Summary
The following documents are current:
The table below provides examples. Ensure to add or reference all required TechDoc records.
| Item | Yes | No | Comment |
|---|---|---|---|
| SOP Clinical Evaluation (Doc-ID) | |||
| Clinical Evaluation Plan (Doc-ID) | |||
| Clinical Evaluation Report (Doc-ID) | |||
| Declaration of Conformity |
The following actions have been completed:
| Checklist Items | Yes | No | Comment |
|---|---|---|---|
| Is the report comprehensible to an independent third party and does it provide enough detail to understand the available data, assumptions made, and conclusions drawn? | |||
| If the manufacturer holds clinical data, are all relevant data mentioned and adequately summarized in the report? | |||
| If equivalence is claimed: | |||
| – Is the equivalence demonstration included in the report? | |||
| – Does the report detail any differences between the evaluated device and the equivalent device? | |||
| – Does it explain why these differences are not expected to impact clinical performance or safety? | |||
| If the product is already marketed in Europe or other regions, has the latest PMS/PMCF data been considered and summarized in the report? | |||
| Regarding current knowledge and state of the art: | |||
| – Has the report been updated to reflect current knowledge? | |||
| – Is the current state of the art adequately summarized and supported by literature? | |||
| – Does the report align with the current state of the art? | |||
| – Does the report justify why the benefit/risk profile and potential side effects are deemed acceptable relative to current knowledge? | |||
| For reports covering multiple models, sizes, settings, or clinical situations, is there sufficient clinical evidence and are the conclusions accurate for: | |||
| – All devices? | |||
| – All sizes, models, and settings (e.g., smallest/largest size, highest/lowest dose, etc.)? | |||
| – Each medical indication (as specified in the IFU or not contraindicated)? | |||
| – The entire intended population (e.g., from preterm infants to elderly, male and female, if not restricted in the IFU)? | |||
| – All stages and severities of the medical condition, if applicable (e.g., acute/chronic, most severe/benign forms, if not excluded in the IFU)? | |||
| – All intended users (e.g., laypersons, if not excluded in the IFU, or unique user groups)? | |||
| – The entire duration of product use, including maximum repeated exposure as per the IFU? | |||
| – If there are discrepancies in the above, are these clearly noted in the report’s conclusions? | |||
| Is compliance with each relevant Essential Requirement (AIMDD ER1,2,5 / MDD ER1,3,6) clearly stated, and are discrepancies noted in the report’s conclusions? | |||
| Do the provided information materials match the content of the report, with any discrepancies noted in the report’s conclusions? | |||
| Does the report identify all residual risks, uncertainties, or unanswered questions that should be addressed through PMS/PMCF studies? | |||
| Is the report dated? | |||
| Are the evaluators’ qualifications included and correct? | |||
| Does the manufacturer possess current CVs and declarations of interest for each evaluator? |
4. Additional Comments
5. Outcome
[ ] Checklist passed\
[ ] Checklist not passed\
[ ] Checklist passed with the following conditions: