MDCG 2020-8：PMCF评估报告模板
文件编号：MDCG 2020-8
发布日期：2020年5月
适用法规：EU MDR 2017/745
官方PDF：下载
文件目的
本文件提供了上市后临床跟踪（PMCF）评估报告的模板，帮助制造商满足EU MDR附件XIV第B部分第7节的要求。
PMCF评估报告的法规要求
PMCF评估报告须：
- 记录PMCF活动的结果
- 评估PMCF数据对CER的影响
- 说明是否需要更新风险管理文件
- 纳入PSUR（定期安全更新报告）
PMCF评估报告模板结构
第1节 — 器械标识
与PMCF计划中的器械标识信息一致。
第2节 — PMCF活动摘要
| PMCF活动 | 计划状态 | 实际执行情况 | 偏差说明 |
|---|---|---|---|
| 文献综述 | 已完成 | — | — |
| 不良事件分析 | 已完成 | — | — |
| PMCF研究 | — | — | — |
第3节 — PMCF数据分析
安全性数据：
- 不良事件汇总（按严重程度分类）
- 与预期不良事件的比较
- 新识别的风险
性能数据：
- 主要性能指标结果
- 与预期性能的比较
- 长期性能趋势
文献综述结果：
- 搜索策略和结果
- 相关文献摘要
- 新的科学证据
第4节 — 对CER的影响评估
- PMCF数据是否支持CER中的结论
- 是否需要更新CER
- 是否需要更新风险管理文件
- 是否需要修改PMCF计划
第5节 — 结论
- PMCG活动的总体评估
- 器械安全性和性能的当前状态
- 后续行动计划
关键注意事项
- PMCF评估报告须定期更新（至少与PSUR同步，通常每年一次）
- 若PMCF数据显示新的安全性问题，须立即更新风险管理文件
- PMCF评估报告须由具备临床评价能力的人员撰写
相关文件
官方文件全文
MDCG 2020-8
Post-market clinical follow-up (PMCF) Evaluation Report Template A guide for manufacturers and notified bodies
April 2020
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law.
MDCG 2020-8
Introduction
The Medical Device Regulation (EU) 2017/745 (MDR) considers the post-market clinical follow-up (PMCF) as a continuous process that updates the clinical evaluation and that shall be addressed in the manufacturer's post-market surveillance plan. The MDR reinforces the PMCF process by the manufacturer, devoting part B of Annex XIV to it and providing a set of requirements for developing a PMCF plan and its evaluation report, necessary to its implementation.
The manufacturer shall analyse the findings coming from the activities foreseen in the PMCF plan and document the results in this PMCF evaluation report that shall be part of the clinical evaluation report and the technical documentation.
The conclusions of the PMCF evaluation report shall be taken into account to update eventually the clinical evaluation, the risk management documentation, the post market surveillance plan and the SSCP, if applicable.
The purpose of the present templates is to guide manufacturers in complying with the requirements of the MDR with respect to the compilation of the PMCF evaluation report. This would assist manufacturers in a harmonised and complete presentation of post market clinical data and facilitate the activity of notified bodies and competent authorities in finding the information in an organized format.
Post-market clinical follow-up evaluation report Template
Post-market clinical follow- up (PMCF) plan corresponding to the present evaluation report
PMCF plan number and version:
Post-market clinical follow- up (PMCF) Evaluation Report
PMCF report number:
PMCF report date:
PMCF report version:
Revision history
Rev
Revision date
Description of change
Revised by
| Rev | Revision date | Description of change | Revised by |
|---|
Section A. Manufacturer contact details
Legal manufacturer name:
Address:
SRN:
Person responsible for regulatory compliance:
E-mail:
Phone:
Fax:
Authorised representative (if applicable):
Contact person:
Section B. Medical Device description and specification
Refer to section B from PMCF plan, if there are no changes. If there are changes from PMCF plan, please fill in the different requested fields highlighting those changes.
Product or trade name:
Model and type:
General description of the device:
Intended purpose 1
Intended users
Basic UDI-DI:
Intended patient population:
Medical condition(s) 2 :
Indications:
Contraindications:
Warnings:
List and description of any variants and/or configurations covered by this plan:
List of any accessories covered by this plan:
Certificate number (if available):
CND code(s) 3 :
Class:
Classification rule:
Expected lifetime 4
Novel product
[ ] ☐ yes
[ ] ☐ no
Novel related clinical procedure:
[ ] ☐ yes
[ ] ☐ no
Explanation of any novel features:
Section C. Activities undertaken related to PMCF: results
In this section the manufacturer shall report all the activities described in section C of the PMCF plan which have been performed, all the collected clinical data obtained from those completed activities, as well as any justification of deviations from the plan.
The discussion shall include the analysis of the findings, whether positive or negative and also the potential impact on the different documents (clinical evaluation report, risk management file, SSCP, etc…) initially reviewed during the conformity assessment.
It is expected for each activity performed, a description in different subsections, related to the type of activities (device registry, PMCF studies, real world evidence, surveys about the use of device, etc…), and for each subsection, a description about the quality of data collected. 5
Section D. Evaluation of clinical data relating to equivalent or similar devices
In this section the manufacturer shall report all the clinical data collected relating to an equivalent device or selected similar device(s), provide an analysis and conclusions, and whether changes of the state of the art, or newly identified hazards would have an impact on the devices benefit-risk determination, the clinical evaluation and/or the PMCF plan.
Product name of equivalent / similar device
Results discussed
Section E. Impact of the results on the technical documentation
References used to get the results (publications, part of technical documentation from this equivalent / similar device)
In this section, the manufacturer shall discuss the aggregate results coming from each PMCF activity planned and performed, described in section C, but also results coming from equivalent and/or similar device, described in section D, which are considered to impact the technical documentation and at least the following documents shall be considered:
1 . Clinical evaluation report - CER (date and version)
[ ] ☐ No relevant information from the clinical evaluation report have been considered.
If applicable, it is expected from manufacturer to describe why some information that might have an impact on the CER have not been considered.
Relevant information analyzed and monitored:
Analysis of the outcome is to be reported in the updated clinical evaluation report.
- Risk management file (date and version)
- [ ] ☐ No relevant information from the risk management file have been considered
If applicable, it is expected from manufacturer to describe why some information that might have an impact on the risk management file have not been considered.
Analysis outcome to be reported in the risk management file updated:
Section F. Reference to any common specification(s), harmonized standard(s) or guidance document(s) applied
In this section the manufacturer should point out whether the collected clinical data related the device in question still confirm adherence to applied common specifications and/or applied harmonized standards, and/or guidances listed in the PMCF plan.
Common Specification(s) applied (Title, date and version)
Harmonised standard(s) applied (Title, date and version)
Guidance(s) followed (Title, date and version
)
Section G. Conclusions
In this section, it is expected that the manufacturer shall provide an overall conclusion of the findings and relate them to the aims of the PMCF plan. The conclusions shall be taken into account in the following clinical evaluation and in the risk management. Finally, this conclusion shall highlight if any need for preventive and/or corrective measures has been identified. The conclusion may also give input to the next PMCF plan.
Footnotes
- Intended purpose means the use for which a device is intended according to the data supplied by the manufacturer on the label in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation (MDR, Article 2(12)).
- It refers to the clinical condition that is to be diagnosed, prevented, monitored, treated, alleviated, compensated for, replaced, modified or controlled by the medical device.
- The expected lifetime is to be defined during the design input phase by considering the current state of the art for a specific intended use and indication of a device.
- For the analysis and assessment of the clinical data collected, some parts of section 9.3.1 from Meddev 2.7/1 rev.4 could be used to assess the quality of data.