EUROPEAN COMMISSION
DG ENTERPRISE
Directorate G
Unit 4 - Pressure Equipment, Medical Devices, Metrology
MEDICAL DEVICES: Guidance document MEDDEV 2.12-2 |
May 2004 |
GUIDELINES ON POST MARKET CLINICAL FOLLOW-UP
上市后臨床跟蹤指南
The present Guidelines are part of a set of Guidelines relating to questions of application of EC-Directives on medical devices. They are legally not binding. The Guidelines have been carefully drafted through a process of intensive consultation of the various interested parties (competent authorities, Commission services, industries, other interested parties) during which intermediate drafts were circulated and comments were taken up in the document. Therefore, this document reflects positions taken by representatives of interested parties in the medical devices sector.
本準(zhǔn)則是一個有關(guān)的歐共體指令對醫(yī)療設(shè)備的應(yīng)用問題指引的一部分。他們在法律上沒有約束力。該指引已審慎草擬通過各有關(guān)方面（主管機(jī)關(guān)，委員會的服務(wù)，工業(yè)，其他有關(guān)各方）在此期間，中間草案分發(fā)和評論的文件采取了密集的磋商進(jìn)程。因此，這份文件反映了有關(guān)各方的代表在該領(lǐng)域采取的醫(yī)療設(shè)備的位置。
Foreword : Rationale and Goals of PMCF
This document is intended to be a guide for manufacturers and notified bodies on how to carry out PMCF in order to fulfill post market surveillance obligation according to point 3. 1 of annex II, point 3. of annex IV, point 3 of annex V, point 3.1 of annex VI or point 4 of annex VII of medical device directive (add ref. AIMDD)
While clinical evidence is an essential element of the premarket conformity assessment process, it is important to recognize the limitations inherent to these premarket clinical investigations. The extent of the data that can be gathered in the premarket phase does not enable the manufacturer to detect infrequent complications or problems only apparent after widespread use, or /long term performance issues. As part of the manufacturer’s quality system, a program of appropriate post market surveillance is key to identifying and investigating risks associated with the use of medical devices placed on the market.
前言：PMCF的基本原理和目標(biāo)
本文件的目的是為制造商的指引，就如何開展PMCF為了履行市場監(jiān)督義務(wù)后按3點(diǎn)通知機(jī)構(gòu)。 1附件二點(diǎn)三。附件四，附件三點(diǎn)五，六31點(diǎn)附件或附件4點(diǎn)的醫(yī)療設(shè)備指令（七加號。AIMDD）
雖然臨床證據(jù)是對上市前合格評定程序的基本要素，重要的是要認(rèn)識到這些固有的局限性上市前的臨床調(diào)查。制造商可能在上市前階段收集不到罕見的并發(fā)癥或問題后，才廣泛使用，或/長期性能問題的明顯數(shù)據(jù)的程度。作為制造商的質(zhì)量體系，一個適當(dāng)?shù)氖袌霰O(jiān)督計劃的一部分后的關(guān)鍵是查明和調(diào)查與對市場上使用的醫(yī)療器械相關(guān)的風(fēng)險。
Manufacturers should have general systems in place to cover PMS as well as having a defined PMS strategy for each of their products/product ranges
Therefore, PMCF appears as a method of choice for this purpose. It will, for instance, enable patients' access to new therapies while establishing a review process for long term safety follow-up and detection of possible emergent risks that cannot be adequately detected by relying solely on pre-market clinical investigations (given the relatively short follow up required) or product experience /vigilance.
Implementation
Post market surveillance may include a number of strategies in addition to complaint handling and vigilance :
?active supervision by customer surveys,
?inquiries of users and patients,
?literature reviews,
?Post market Clinical Follow-up, etc..
Post market clinical follow-up (PMCF) through clinical studies and registries has a great importance among these strategies.
制造商應(yīng)建立上市后監(jiān)督系統(tǒng)，除非每一個產(chǎn)品均建立了明確的PMS（上市后監(jiān)督）的系統(tǒng)。
因此，PMCF顯示為所選擇的這個目的的方法。它將，例如，使病人獲得，而建立一個長期的安全審查程序的新療法的后續(xù)行動和可能的，不能充分依靠市場前的僅僅臨床調(diào)查中（由于較短發(fā)現(xiàn)突發(fā)風(fēng)險檢測跟進(jìn)要求）或產(chǎn)品的經(jīng)驗(yàn)/警惕。
實(shí)施
上市后監(jiān)督除了處理投訴和警械系統(tǒng)還可以包括很多形式，例如：
?顧客反饋管理
用戶和患者調(diào)查，
?文獻(xiàn)評論，
?上市后的臨床隨訪等。
通過臨床研究和臨床登記處市場的后續(xù)行動（PMCF）這些戰(zhàn)略之間有一個非常重要的。
Post Market Clinical Follow-up (PMCF) should always be considered for devices where identification of possible emerging risks and the evaluation of long term safety and performance are critical. In identifying such emerging risk, the following criteria should be taken into account :
? innovation, when the design of the device, the material, the principles of operation, the technology, or the medical indication is new
? severity of the disease,
? sensitive target population
? risky anatomical location
? well known risk from the literature
? well known risk of similar marketed devices
? Identification of an acceptable risk during pre-CE clinical evaluation, which should be monitored in a longer term and/or through a larger population.
? Obvious discrepancy between the premarket follow up timescales and the expected life of the product
上市后監(jiān)督（PMCF）可視為對設(shè)備可能出現(xiàn)的風(fēng)險和長期的安全和性能評價。在識別這種新出現(xiàn)的風(fēng)險，應(yīng)考慮到下面的標(biāo)準(zhǔn)：
?該設(shè)備采用新的設(shè)計，材料，操作準(zhǔn)則，技術(shù)，或者是新的醫(yī)學(xué)特征
?嚴(yán)重的疾病，
?敏感目標(biāo)人群
?危險的解剖位置
?文獻(xiàn)發(fā)表的風(fēng)險
?已上市類似設(shè)備存在風(fēng)險
?確認(rèn)在一個CE前臨床評價可接受的風(fēng)險，應(yīng)長期和/或監(jiān)測更多的臨床人員。
?臨床使用時間和產(chǎn)品的預(yù)期壽命的差別。
All PMCF should be planned. The PMCF plan can take the form of extended follow-up of patients enrolled in the pre-market trials, and / or a prospective study of a representative subset of patients after the device is placed on the market. It can also take the form of open registries. This plan will need to take into account :
? Results of the clinical investigation including Adverse events identified
? Average life expectancy of the device
? The claims made by the manufacturer for the device
? Performances for which equivalence is claimed
? New information becoming available
PMCF, when carried out, must always be performed for the use of the product within its intended indications according to Instructions for use. National regulations on post market clinical studies must be taken into account.
所有PMCF應(yīng)計劃。該PMCF計劃可以采取病人后續(xù)的觀察形式，包括市場前的評審，和/或設(shè)備已投放市場后有代表性病人的前瞻性研究，可以采取開放登記表格，這個計劃將需要考慮到：
?臨床調(diào)查，包括確定的不良事件結(jié)果
?設(shè)備的平均預(yù)期壽命
?設(shè)備制造商聲明
?聲明的性能
?適當(dāng)可用的新信息
實(shí)施PMCF時，必須始終依據(jù)產(chǎn)品的預(yù)定適用范圍內(nèi)按使用說明使用。對上市后的臨床研究必須考慮到相應(yīng)國家的法規(guī)。
The involved Notified Body should review the appropriateness of the manufacturer's general PMS procedures, incorporating PMCF, as relevant, as well their PMCF plan(s) and results for specific products as part of conformity assessment procedures and quality management system auditing
The follow up duration should take into account the average life expectancy of the product in its indication. Therefore, in case of a device subject to short term premarket follow up and intended to stay in the patient for its lifetime, a longer follow up will be required.
PMCF will not be required for products for which the long term clinical performance and safety is already known from previous use of the device. In the case the assessment of a product is performed through the concept of equivalence , PMCF should always be considered .
所涉及的公告機(jī)構(gòu)應(yīng)審查合格評定程序和質(zhì)量管理體系，制造商的一般PMS的程序是否恰當(dāng)，，以及他們的PMCF計劃（s）和特定產(chǎn)品的審計結(jié)果
隨訪時應(yīng)考慮到其標(biāo)志產(chǎn)品的平均預(yù)期壽命。因此，如果在一個設(shè)備在上市前跟進(jìn)時間較短，并打算留在患者一生中，一個較長的病人會跟進(jìn)是必須。
對需要長期臨床觀察和安全設(shè)備已經(jīng)已知的產(chǎn)品不需要PMCF。在情況下可以通過等效的原則對個產(chǎn)品進(jìn)行評估，PMCF應(yīng)始終考慮。
Post Market clinical Requirements (Risk based matrix)
The following table sets out a ‘triage approach’ and suggests general advice for the evaluation of products under different circumstances.
Notified bodies should be part of the decision making with the manufacturer if applicable.
上市后的臨床需求（基于風(fēng)險模型）
下表列出了一個'分類方式'，并建議在不同情況下對產(chǎn)品進(jìn)行評價的一般意見。
通告機(jī)構(gòu)應(yīng)當(dāng)是制造商作出判斷是否適用的一部分。
PMCF | Product specificities 產(chǎn)品特點(diǎn) | Required actions 需要采取的行動 |
no PMCF | Products for which the medium/long term clinical performance and safety is already known from previous use of the device , or from fully transferable experience with equivalent devices (except **) 該產(chǎn)品為中/長期的臨床表現(xiàn)和安全已經(jīng)從設(shè)備，從完全轉(zhuǎn)讓或具有同等設(shè)備（除**以前使用已知的經(jīng)驗(yàn)） | ? All received complaints and adverse events data shall be systematically reviewed, and all product related adverse events such as those described in Annex II 3.1 of the MDD must be notified to the relevant Competent Authority (ies). This includes all sources of information known by the manufacturer, including published literature. ? Monitoring of postmarket performance should take into account relevant data publicly available with similar devices especially when the CE marking was based on equivalence. ?所有收到的投訴及不良反應(yīng)的數(shù)據(jù)，應(yīng)系統(tǒng)地評價，以及所有與產(chǎn)品相關(guān)的，如附件二3.1 MDD的描述的不良反應(yīng)事件，必須預(yù)先通知有關(guān)主管部門（們）。這包括由制造商已知信息，包括出版文獻(xiàn)的所有來源。 |
PMCF | Always considered for devices where identification of possible emerging risks and the evaluation of long term safety and performance are critical (**)Products quoted as "equivalent" devices where reference product is subjected to PMCF 可能出現(xiàn)新的風(fēng)險識別、安全和性能需要長期的評估的產(chǎn)品 （**）當(dāng)做“類似”的器械產(chǎn)品，應(yīng)當(dāng)參照被引用產(chǎn)品的PMCF。 | ? Same as above , ? Plus ? Post-Market Clinical Follow-up (PMCF) in the form of follow up of all or a justifiable subset of patients already enrolled in pre-marketing Clinical Investigations; or on specific sub-groups and/or prospective study or registry of a sample of products. A formal protocol should describe the duration of PMCF; identify patient population and data to be collected. (NOTE: The manufacturer must justify the design, nature, and duration of post-marketing follow-up, having regard to any published standards) PMCF report to be provided to the relevant NB for review and to competent authority if requested. ?與上述相同， ?上市后臨床隨訪中的跟進(jìn)調(diào)查包括上市前的全部或一部分病人的情況，或就具體分組和/或前瞻性研究或樣品登記產(chǎn)品。一個正式的協(xié)議中應(yīng)敘述PMCF期限;查明的患者群和數(shù)據(jù)收集。 |
*Equivalence has been precisely defined and should be demonstrated according to the criteria described in the document “Evaluation of clinical data: A guide for manufacturers and notified bodies” (see annex 1 of this document).
*等價已明確界定，應(yīng)根據(jù)本文標(biāo)準(zhǔn)事例：“所描述的臨床資料評價的標(biāo)準(zhǔn)：制造商和公告機(jī)構(gòu)的指領(lǐng)”（見本文件附件1）。
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