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嘉峪檢測(cè)網(wǎng) 2026-03-30 11:12
對(duì)于布局歐盟市場(chǎng)的醫(yī)療器械制造商而言，上市后臨床跟蹤（PMCF）是繞不開的MDR合規(guī)核心——它不僅是EU MDR（EU）2017/745的關(guān)鍵要求，更是確保器械全生命周期持續(xù)安全、性能達(dá)標(biāo)的“長(zhǎng)效保障”。
不同于上市前的集中驗(yàn)證，PMCF要求制造商在器械投放市場(chǎng)后，持續(xù)主動(dòng)收集、評(píng)估臨床數(shù)據(jù)，確認(rèn)安全性與性能、識(shí)別未知風(fēng)險(xiǎn)、監(jiān)測(cè)副作用，確保收益-風(fēng)險(xiǎn)比始終可控。而隨著MDR對(duì)PMCF的要求愈發(fā)嚴(yán)格，所有風(fēng)險(xiǎn)類別的器械都需主動(dòng)開展數(shù)據(jù)收集，一個(gè)關(guān)鍵疑問也隨之而來(lái)：若PMCF調(diào)查是非干預(yù)性的，僅收集基于標(biāo)準(zhǔn)臨床實(shí)踐的匿名數(shù)據(jù)，能否豁免正式知情同意和倫理審查？這一問題直接關(guān)系到PMCF計(jì)劃的合規(guī)落地與執(zhí)行成本，今天我們結(jié)合MDR條款、MDCG指南、GDPR及歐盟成員國(guó)要求，為大家拆解核心答案、梳理實(shí)操要點(diǎn)。
先明確：PMCF調(diào)查≠臨床研究，豁免需看“性質(zhì)”
首先要厘清一個(gè)關(guān)鍵邊界：EU MDR對(duì)“臨床研究”的定義是“涉及人類受試者、旨在評(píng)估器械安全或性能的系統(tǒng)性研究”，這既包括上市前研究，也包括上市后的PMCF研究，但并非所有PMCF活動(dòng)都屬于“臨床研究”。MDR明確區(qū)分了PMCF的“一般方法”（如文獻(xiàn)綜述、用戶反饋收集）和“特定方法”（如PMCF研究、注冊(cè)數(shù)據(jù)利用）。而我們關(guān)注的“非干預(yù)性匿名調(diào)查”，可能屬于其中任何一類——這也是能否豁免倫理審查和知情同意的核心前提。簡(jiǎn)單來(lái)說(shuō)：如果調(diào)查僅收集醫(yī)療從業(yè)者的常規(guī)使用反饋，不涉及患者特定數(shù)據(jù)、不改變臨床診療流程，那么它大概率不屬于需要嚴(yán)格遵守臨床研究要求的PMCF研究，豁免的可能性更高；反之，若涉及患者臨床數(shù)據(jù)、可能間接識(shí)別個(gè)人，就需按更嚴(yán)格的標(biāo)準(zhǔn)執(zhí)行。
關(guān)鍵條款拆解：MDR第74條的“彈性空間”
很多人誤以為MDR第74條（針對(duì)CE認(rèn)證器械的臨床研究）要求“倫理委員會(huì)必須全程參與”，但實(shí)際并非絕對(duì)。第74條將PMCF研究分為兩種情況：
1. 評(píng)估器械“預(yù)期用途范圍內(nèi)”的研究：若不涉及額外的侵入性、負(fù)擔(dān)性程序（比如非干預(yù)性匿名調(diào)查），倫理委員會(huì)的參與程度由成員國(guó)法規(guī)決定——部分國(guó)家可能僅要求“倫理咨詢”，而非完整的倫理委員會(huì)批準(zhǔn)；
2. 評(píng)估器械“預(yù)期用途范圍外”的研究：需完全遵守MDR第62-81條要求，倫理審查和知情同意不可豁免。
這里的核心結(jié)論是：非干預(yù)性、無(wú)額外負(fù)擔(dān)的匿名調(diào)查，不必然需要完整的倫理審查和正式知情同意，但具體需結(jié)合所在成員國(guó)的法規(guī)要求判斷，不能一概而論。
MDCG指南：4級(jí)vs8級(jí)調(diào)查，豁免要求大不同
醫(yī)療器械協(xié)調(diào)小組（MDCG）在2020-6號(hào)指南中，將PMCF調(diào)查按證據(jù)水平分為不同等級(jí)，其中與我們相關(guān)的是4級(jí)和8級(jí)，兩者的倫理要求差異顯著：
4級(jí)調(diào)查：旨在解決特定臨床數(shù)據(jù)缺口，需遵循ISO 14155標(biāo)準(zhǔn)，通常需要倫理委員會(huì)批準(zhǔn)，且必須符合GDPR要求——這類調(diào)查多涉及具體臨床結(jié)果數(shù)據(jù)，豁免難度大；
8級(jí)調(diào)查：旨在收集一般性數(shù)據(jù)（如醫(yī)療從業(yè)者的使用體驗(yàn)、記憶中的臨床反饋），監(jiān)管要求更寬松。若僅收集從業(yè)者數(shù)據(jù)、不涉及任何患者識(shí)別信息，通?？苫砻鈧惱砦瘑T會(huì)批準(zhǔn)。
也就是說(shuō)，若你的PMCF調(diào)查屬于“不涉及患者數(shù)據(jù)、僅收集常規(guī)使用反饋”的8級(jí)調(diào)查，豁免倫理審查和正式知情同意的可能性極高；若屬于4級(jí)調(diào)查，則需嚴(yán)格按要求執(zhí)行。
GDPR加持：匿名化是“豁免關(guān)鍵”，但門檻極高
在數(shù)據(jù)收集層面，GDPR與MDR的銜接尤為重要——能否豁免知情同意，核心看數(shù)據(jù)是否達(dá)到“真正的匿名化”。根據(jù)GDPR第26條，真正匿名化的數(shù)據(jù)（無(wú)法通過(guò)任何現(xiàn)有技術(shù)重新識(shí)別個(gè)人），不受GDPR約束，無(wú)需獲得知情同意；但如果數(shù)據(jù)僅為“假名化”（用代碼替換個(gè)人信息，但仍可間接識(shí)別），則仍屬于個(gè)人數(shù)據(jù)，需遵守GDPR要求，通常需要知情同意。這里需要注意：實(shí)現(xiàn)“真正的匿名化”難度極大，需確保沒有任何合理手段能重新識(shí)別個(gè)人（包括考慮識(shí)別所需的成本、時(shí)間和現(xiàn)有技術(shù)）。即使數(shù)據(jù)達(dá)到匿名化，部分倫理委員會(huì)仍可能要求參與監(jiān)督，確保匿名化過(guò)程合規(guī)、無(wú)泄露風(fēng)險(xiǎn)。
倫理委員會(huì)：最終決定權(quán)在“當(dāng)?shù)?rdquo;
倫理委員會(huì)的核心職責(zé)是保護(hù)受試者的權(quán)利、安全和福祉，其參與程度最終由調(diào)查的具體設(shè)計(jì)和當(dāng)?shù)乇O(jiān)管環(huán)境決定。需要明確的是：
1. 若調(diào)查涉及額外侵入性、負(fù)擔(dān)性程序，必須獲得倫理委員會(huì)的有利意見（如德國(guó)要求，需先通過(guò)倫理審查，才能向監(jiān)管機(jī)構(gòu)提交申請(qǐng)）；
2. 若為非干預(yù)性匿名調(diào)查，倫理委員會(huì)可根據(jù)具體情況，決定是否豁免正式審查和書面知情同意——但這一決定是“逐案判斷”，沒有統(tǒng)一標(biāo)準(zhǔn)；
3. 不同歐盟成員國(guó)的倫理委員會(huì)對(duì)法規(guī)的解釋存在差異，最終豁免與否，以當(dāng)?shù)貍惱砦瘑T會(huì)的意見為準(zhǔn)。
實(shí)操建議：6步確保PMCF調(diào)查合規(guī)豁免
結(jié)合上述分析，若你計(jì)劃開展非干預(yù)性匿名PMCF調(diào)查，想要合規(guī)豁免倫理審查和正式知情同意，可按以下步驟操作：
明確定義調(diào)查類型：明確調(diào)查目標(biāo)、數(shù)據(jù)收集方式，判斷是否屬于MDCG 2020-6中的8級(jí)調(diào)查，確認(rèn)數(shù)據(jù)匿名化程度（是否達(dá)到GDPR要求）；
主動(dòng)咨詢當(dāng)?shù)貍惱砦瘑T會(huì)：向調(diào)查所在成員國(guó)的倫理委員會(huì)提交方案，明確咨詢是否可豁免、豁免條件是什么；
完善PMCF計(jì)劃論證：在計(jì)劃中詳細(xì)說(shuō)明豁免理由，包括調(diào)查的非干預(yù)性、匿名化程序、器械現(xiàn)有臨床證據(jù)等，證明豁免不會(huì)影響受試者權(quán)益；
嚴(yán)格遵守當(dāng)?shù)胤ㄒ?guī)：不同成員國(guó)可能有額外要求（如部分國(guó)家要求“患者告知”），需逐一確認(rèn)并落實(shí)；
做好患者告知準(zhǔn)備：即使豁免正式知情同意，也建議制定簡(jiǎn)單的告知程序，保障透明度和患者知情權(quán)；
完整記錄溝通過(guò)程：將與倫理委員會(huì)、監(jiān)管機(jī)構(gòu)的溝通記錄、反饋意見、批準(zhǔn)文件等全部留存，作為合規(guī)證明。
最后總結(jié)
非干預(yù)性匿名PMCF調(diào)查的倫理審查與知情同意，沒有“一刀切”的豁免答案：核心取決于調(diào)查類型（4級(jí)/8級(jí)）、數(shù)據(jù)匿名化程度（真正匿名/假名化）、所在成員國(guó)法規(guī)，以及當(dāng)?shù)貍惱砦瘑T會(huì)的判斷。對(duì)于醫(yī)療器械制造商而言，與其糾結(jié)“能否豁免”，不如先按合規(guī)要求梳理調(diào)查方案，主動(dòng)咨詢當(dāng)?shù)貍惱砦瘑T會(huì)和監(jiān)管機(jī)構(gòu)——這既是MDR的要求，也是規(guī)避合規(guī)風(fēng)險(xiǎn)、確保PMCF數(shù)據(jù)被公告機(jī)構(gòu)認(rèn)可的關(guān)鍵。畢竟，PMCF的核心是“保障器械安全”，而倫理合規(guī)與數(shù)據(jù)保護(hù)，正是這一核心的重要支撐。
如果需要進(jìn)一步梳理你的PMCF調(diào)查類型，或解讀某一成員國(guó)的具體倫理要求，可在評(píng)論區(qū)留言交流～
文獻(xiàn)參考：
一、歐盟 MDR 下 PMCF（上市后臨床跟蹤）核心資料
Why the PMCF is so crucial under EU MDR? – ECLEVAR MedTech
https://www.eclevarmedtech.com/en/why-the-pmcf-is-so-crucial-under-eu-mdr/
The Medical Device Practical Guide to PMCF Requirements under EU MDR – Greenlight Guru
https://www.greenlight.guru/blog/practical-guide-to-the-pmcf-requirements-of-the-eu-mdr
PMCF Post-Market Clinical Follow-up | MDR Compliance Guide – Mantra Systems
https://www.mantrasystems.co.uk/eu-mdr-compliance/post-market-clinical-follow-up-pmcf
Guide to Post-Market Clinical Follow-up Requirements Under EU MDR – NAMSA
https://namsa.com/resources/blog/guide-to-post-market-clinical-follow-up-eu-mdr/
The Importance of PMCF for Medical Devices – Celegence
https://www.celegence.com/importance-post-market-clinical-follow-up-medical-devices-compliance/
EU MDR PMCF Requirements for Medical Devices – Oriel Stat
https://www.orielstat.com/blog/eu-mdr-pmcf/
PMCF studies: framework and principles for medical devices – Efor Group
https://efor-group.com/en/importance-and-design-of-pmcf-studies-for-medical-devices-in-europe-framework-and-principles/
Post-Market Clinical Follow-up: Best Practices for PMCF – Johner Institute
https://blog.johner-institute.com/regulatory-affairs/post-market-clinical-follow-up-pmcf/
PMCF Plan and PMCF Report under MDR What You Should Know
https://clinicalevaluationnavigator.com/pmcf-plan-and-pmcf-report-under-mdr-2017/745-what-you-should-know/
How to write a comprehensive PMCF Plan for medical devices – Milo Healthcare
https://milo-healthcare.com/en/how-to-write-a-comprehensive-pmcf-plan-for-medical-devices-under-the-medical-device-regulation-mdr/
Harnessing the Power of Clinical Data with Post-Market Clinical Follow-Up Activities – Premier Research
https://premier-research.com/perspectives/harnessing-the-power-of-clinical-data-with-post-market-clinical-follow-up-activities/
Understanding the requirements of PMCF – BSI (webinar PDF)
https://www.bsigroup.com/globalassets/meddev/localfiles/en-gb/webinars/bsi-md-clinical-masterclass-pmcf-under-mdr-webinar-160322-en-gb.pdf
Medical Device Regulation (MDR) and the Documents required for Post Market Phases – Prineos
https://prineos.com/en/blog/medical-device-regulation-mdr-and-the-documents-required-for-post-market-phases/
PMS and PMCF Activities for Medical Devices Under the MDR – QbD Group
https://www.qbdgroup.com/en/blog/pms-and-pmcf-activities-for-medical-devices-under-the-mdr?hsLang=en
White Paper: EU PMCF Studies – Emergo
https://www.emergobyul.com/sites/default/files/2022-07/white-paper-eu-pmcf-studies.pdf
When, Why, and How to Use PMCF Surveys – NAMSA
https://namsa.com/resources/blog/when-why-and-how-to-use-post-market-clinical-follow-up-pmcf-surveys/
MDR requirements for PMCF investigations – BSI Compliance Navigator
https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/mdr-requirements-for-pmcf-investigations/
PMCF studies and Article 74 of the MDR – medXteam
https://www.medxteam.de/en/medxteam-blog/pmcf-studies-and-article-74-of-the-mdr
PMCF studies: three types to be distinguished – Johner Institute
https://blog.johner-institute.com/regulatory-affairs/pmcf-studies-three-types-to-be-distinguished/
MDR 2017/745 Post-Market Follow-up – PMCF Clinical investigation – ECLEVAR
https://www.eclevarmedtech.com/en/mdr-2017/745-art-74-1-post-market-follow-up-pmcf-clinical-investigation-with-medical-devices-submissions-in-germany/
Observational PMCF study – ECLEVAR
https://www.eclevarmedtech.com/en/observational-pmcf/
PMCF: Post Market Clinical Follow-Up & MDCG’s Latest Guidance – Cite Medical
https://citemedical.com/post-market-clinical-follow-up-pmcf-understanding-mdcgs-latest-guidance/
EU MDR PMCF: To Waive or Not to Waive – ComplianceAcuity
https://www.complianceacuity.com/eu-mdr-pmcf-to-waive-or-not-to-waive/
MedTech Digital Week PMCF Q&A – ECLEVAR
https://www.eclevarmedtech.com/en/medtech-digital-week-pmcf-clinical-investigations-and-other-studies-04-oct-2022-question-and-answers/
PMCF Surveys – Evnia
https://www.evnia.dk/pmcf-surveys/
Tips to Design a High-Quality PMCF User Survey – Qserve CRO
https://qservecro.com/tips-to-design-a-pmcf-high-quality-user-survey/
Q&A: PMCF User Feedback Surveys – RQM+
https://www.rqmplus.com/blog/qa-pmcf-user-feedback-surveys
二、MDR 下醫(yī)療器械臨床研究 / 臨床調(diào)查（Clinical Investigation）
Medical device clinical investigations — What’s new under the MDR? – BSI (whitepaper)
https://www.bsigroup.com/globalassets/localfiles/en-gb/medical-devices/whitepapers/clinical-investigations-update/clinical-investigation-update.pdf
Introduction to clinical investigations of medical devices – DMP
https://www.dmp.no/en/medical-devices/clinical-investigation-of-medical-devices/introduction-to-clinical-investigation-of-a-medical-device
Variations in FDA and EU MDR Clinical Investigations – StarFish Medical
https://starfishmedical.com/resource/variations-between-fda-and-eu-mdr-clinical-investigations/
Clinical investigations: definition and framework – CCMO
https://english.ccmo.nl/investigators/clinical-investigations-with-medical-devices/legal-framework-guidances-and-standards-for-clinical-investigations/clinical-investigations-definition-and-framework
Medical device clinical investigations – What’s new under the MDR? (PDF)
https://www.medical-device-regulation.eu/wp-content/uploads/2020/09/Clinical_Investigation_Revised_v2.pdf
Understanding the Post-market Clinical Investigation Under the EU MDR 2017/745 – Freyr
https://www.freyrsolutions.com/blog/understanding-the-post-market-clinical-investigation-under-the-eu-mdr-2017745
ISO 14155: How It Impacts PMCF Investigations Under the MDR – Castor
https://www.castoredc.com/blog/iso14155-pmcf-mdr-impact/
Notification of a Post-Market Clinical Follow-up investigation (Art.74 MDR) – BfArM
https://www.bfarm.de/EN/Medical-devices/Tasks/Clinical-investigations-and-performance-studies/Clinical-investigations/Notification-post-market-pmcf-kp/_artikel.html
MDR – Article 74 – Clinical investigations regarding CE marked devices
https://www.medical-device-regulation.eu/2019/07/15/mdr-article-74-clinical-investigations-regarding-devices-bearing-the-ce-marking/
Clinical investigations of medical devices under the MDR – regulatory pathway – Johner Institute
https://blog.johner-institute.com/regulatory-affairs/clinical-investigations-of-medical-devices/
4 Scenarios When High Risk Devices May Be Exempt from Mandatory Clinical Investigations Under EU MDR – Premier Research
https://premier-research.com/perspectives/4-scenarios-when-high-risk-devices-may-be-exempt-from-mandatory-clinical-investigations-under-eu-mdr/
Regulation (EU) 536/2014 and the role of ethics committees (PMC)
https://pmc.ncbi.nlm.nih.gov/articles/PMC11552528/
PMS data: When you need an ethics committee – Johner Institute
https://blog.johner-institute.com/regulatory-affairs/pms-data-ethics-committee/
三、MDCG 官方指南 & 通用法規(guī)文件
MDCG 2021-6 rev.1
https://health.ec.europa.eu/system/files/2023-12/mdcg_2021-6_en.pdf
MDCG 2020-8 – PMCF Evaluation Report Guidance
https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_8_guidance_pmcf_evaluation_report_en_0.pdf
MDCG 2024-3 Guidance on content of the Clinical Investigation Plan
https://health.ec.europa.eu/document/download/690de85a-ac17-45ea-bb32-7839540c25c4_en?filename=mdcg_2024-3_en_0.pdf
MDCG endorsed documents and other guidance – European Commission
https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en
QA data protection and clinical trials – European Commission
https://health.ec.europa.eu/document/download/c3042973-b36d-4094-a1fb-a6fc980f065e_en
四、GDPR & 數(shù)據(jù)隱私 / 匿名化 / 倫理（臨床試驗(yàn)相關(guān)）
ANONYMISATION – EDPS
https://www.edps.europa.eu/system/files/2021-04/21-04-27_aepd-edps_anonymisation_en_5.pdf
PREPARING FOR THE EU GDPR IN RESEARCH SETTINGS – Johns Hopkins
https://publichealth.jhu.edu/sites/default/files/2023-09/gdprapplication-in-research-settings-1.pdf
What are the Differences Between Anonymisation and Pseudonymisation – Privacy Company
https://www.privacycompany.eu/blog/what-are-the-differences-between-anonymisation-and-pseudonymisation
Should my medical device comply with GDPR? – MDRC
https://mdrc-services.com/medical-devices-and-gdpr/
GDPR in Human Subjects Research (HSR) Q&A – JHURA
https://jhura.jhu.edu/wp-content/uploads/2018/12/GDPR-QA.pdf
Anonymization and GDPR compliance; an overview – GDPR Summary
https://www.gdprsummary.com/anonymization-and-gdpr/
What’s new for Data Privacy under Medical Device Regulation? – MyData-TRUST
https://www.mydata-trust.com/2021/12/medical-device-regulation/10214/
How Does the EU GDPR Impact Medical Device Clinical Trials? – Greenlight Guru
https://www.greenlight.guru/blog/how-eu-gdpr-impacts-medical-device-clinical-trials
Recital 26 – Not Applicable to Anonymous Data
https://gdpr-info.eu/recitals/no-26/
Can Europe unlock the power of data while protecting privacy? – MedTech Europe
https://www.medtecheurope.org/medtech-views/policy-views/can-europe-unlock-the-power-of-data-while-protecting-privacy/
GDPR Brief: can genomic data be anonymised? – GA4GH
https://www.ga4gh.org/news_item/can-genomic-data-be-anonymised/
GDPR and unstructured data: is anonymization possible? – Oxford Academic
https://academic.oup.com/idpl/article/12/3/184/6552802
Ethics and data protection – European Commission
https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ethics-and-data-protection_he_en.pdf
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