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.
本準則是一個有(you)關(guan)的(de)(de)歐(ou)共體指令(ling)對醫療(liao)設(she)備(bei)的(de)(de)應用問題指引的(de)(de)一部分。他(ta)們在法律(lv)上沒有(you)約(yue)束力。該指引已審慎草擬(ni)通過各(ge)有(you)關(guan)方面（主管機(ji)關(guan)，委員會(hui)的(de)(de)服務，工業，其他(ta)有(you)關(guan)各(ge)方）在此期間(jian)，中間(jian)草案分發和評(ping)論的(de)(de)文件采(cai)取(qu)了密(mi)集的(de)(de)磋(cuo)商進(jin)程。因此，這份(fen)文件反映了有(you)關(guan)各(ge)方的(de)(de)代表(biao)在該領域采(cai)取(qu)的(de)(de)醫療(liao)設(she)備(bei)的(de)(de)位(wei)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(yuan)理(li)和(he)目標
本文件的目的是為制造商的指引，就如何開展PMCF為了履行市場監督義(yi)務后(hou)按3點通知機構。 1附件二點三。附件四，附件三點五，六31點(dian)附件(jian)或附件(jian)4點的醫(yi)療設備指令（七(qi)加號。AIMDD）
雖然臨床證據是對上市前合格評定程序的基本要素，重要的是要認識到這些固有的局限性上市前的臨床調查。制造商可能在上市前階段收集不到罕見的并發癥或問題后，才廣泛使用，或/長期性能問題的(de)(de)(de)明(ming)顯數據的(de)(de)(de)程度。作為制造商的(de)(de)(de)質量(liang)體(ti)系(xi)，一個適(shi)當(dang)的(de)(de)(de)市(shi)場監督(du)計劃(hua)的(de)(de)(de)一部分后的(de)(de)(de)關鍵是查(cha)明(ming)和調查(cha)與對市(shi)場上使用(yong)的(de)(de)(de)醫療器械相關的(de)(de)(de)風(feng)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(shang)應建立(li)上(shang)(shang)市后監督系(xi)統(tong)，除非(fei)每一個產品均建立(li)了明確的PMS（上(shang)(shang)市后監督）的系(xi)統(tong)。
因此，PMCF顯示為所選擇的(de)(de)(de)(de)(de)(de)這個目(mu)的(de)(de)(de)(de)(de)(de)的(de)(de)(de)(de)(de)(de)方法。它將，例如，使病人獲(huo)得，而(er)建立(li)一個長(chang)期的(de)(de)(de)(de)(de)(de)安全(quan)審查(cha)程序的(de)(de)(de)(de)(de)(de)新療(liao)法的(de)(de)(de)(de)(de)(de)后續行動和可能的(de)(de)(de)(de)(de)(de)，不能充(chong)分依靠(kao)市場前(qian)的(de)(de)(de)(de)(de)(de)僅僅臨床(chuang)調查(cha)中（由于較(jiao)短發現突發風險檢(jian)測跟進要求(qiu)）或(huo)產品的(de)(de)(de)(de)(de)(de)經驗/警(jing)惕。
實施
上市后監督除了處理投訴和警械系統還可以包括很多形式，例如：
?顧客反饋管理
用戶和患者調查，
?文獻評論，
?上市后的(de)臨床隨訪等。
通過臨床研究和臨床登記處市場的后續行動（PMCF）這(zhe)些戰略之(zhi)間有(you)一個非常重要(yao)的(de)。
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
上市后監督（PMCF）可視為對設備可能出現的風險和長期的安全和性能評價。在識別這種新出現的風險，應考慮到下面的標準：
?該設(she)備(bei)采用新的設計，材料，操作準則，技術，或者是新的醫學特征
?嚴重的疾(ji)病，
?敏(min)感目標人群
?危險的解剖位置(zhi)
?文獻發表的風險
?已上市類似設備存在風險
?確認在一個CE前臨床評價可接受的風險，應長期和/或監測更多的臨床人員。
?臨床使用(yong)時(shi)間和(he)產品(pin)的預期壽命的差(cha)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應計劃。該PMCF計劃可以采(cai)取病(bing)人后續的觀察形式，包括市場前的評審，和/或設備已(yi)投放市場后有代(dai)表(biao)性(xing)病人的前(qian)瞻性(xing)研究(jiu)，可以(yi)采取開放登記表(biao)格，這個計劃(hua)將需要(yao)考慮到：
?臨床調查，包括確定的不(bu)良事(shi)件結(jie)果
?設備的平均(jun)預期(qi)壽命
?設備(bei)制造商(shang)聲明
?聲明的性能
?適當可用的新信息
實施PMCF時(shi)，必須始終依據(ju)產品的預(yu)定適用范(fan)圍內按使用說明使用。對上市后的臨床研究必須考慮到相(xiang)應(ying)國家的法(fa)規。
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 .
所涉及的公告機構應審查合格評定程序和質量管理體系，制造商的一般PMS的(de)程序是否(fou)恰當，，以及他(ta)們的(de)PMCF計劃（s）和特定產品的審(shen)計結果(guo)
隨訪時應考慮到其標志產品的平均預期壽命。因此，如果在一個設備在上市前跟進時間較短，并打算留在患者一生中，一個較長的病人會跟進是必須。
對需要長期臨床觀察和安全設備已經已知的產品不需要PMCF。在情況下(xia)可以通過等效的原則對個產品進行評估，PMCF應始(shi)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（基于風險模型）
下表列出了一個'分類方式'，并建議在不同情(qing)況下對產品進行評價的一般意見。
通告機(ji)構(gou)應當(dang)是(shi)制造商作出判(pan)斷是(shi)否(fou)適用的一部分。
PMCF | Product specificities 產品特點 | 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 **) 該產品為中/長期的臨床(chuang)表(biao)現和安全(quan)已經從設備(bei)，從完(wan)全(quan)轉讓(rang)或具有同等設備(bei)（除**以(yi)前使用已知的經驗） | ? 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(de)(de)投訴及不良反應的(de)(de)數據，應系統地評價，以及所有與產品相關的，如附件二3.1 MDD的(de)描(miao)述(shu)的(de)不良反應事件，必須預先通知(zhi)有(you)關主(zhu)管部門(men)（們）。這(zhe)包括(kuo)由(you)制造商已知(zhi)信息，包括(kuo)出(chu)版文獻(xian)的(de)所有(you)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(neng)出現新的(de)風險識別、安全(quan)和性能(neng)需要長期的(de)評估的(de)產品 （**）當做“類似”的器械產品(pin)，應當參照被引用(yong)產品(pin)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(yu)上述(shu)相同， ?上市后臨床隨訪(fang)中的(de)跟進調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(huo)前瞻性研究或(huo)樣品登記(ji)產品。一個(ge)正式的協(xie)議中應敘述(shu)PMCF期限(xian);查明的患者群和數據收集。 |
*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(ding)，應根據本文標準事例：“所描(miao)述(shu)的臨床資料評價的標準：制造(zao)商和公告機構的指領”（見本(ben)文件(jian)附(fu)件(jian)1）。
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