MDCG 2020-9
REGULATORY REQUIREMENTS FOR VENTILATORS AND RELATED ACCESSORIES
呼吸機及相關(guān)配件的法規(guī)要求
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.
本文件已由法規(guī)(EU)2017/745第103條成立的醫(yī)療器械協(xié)調(diào)小組(MDCG)認可。MDCG由所有成員國的代表組成，由歐盟委員會的代表主持。該文件不是歐盟委員會文件，不能視作歐盟委員會的正式立場。本文檔中表達的任何觀點均不具有法律約束力，只有歐盟法院可以對歐盟法律做出具有約束力的解釋。
REGULATORY REQUIREMENTS FOR VENTILATORS AND RELATED ACCESSORIES
呼吸機及相關(guān)配件的法規(guī)要求
Options for supporting production and/or placing on the market of ventilators in the context of COVID-19 pandemic
在COVID-19流行的背景下支持呼吸機生產(chǎn)和/或投入市場
01
INTRODUCTION AND SCOPE
介紹和范圍
The World Health Organization (WHO) declared the COVID-19 outbreak a pandemic on March the 12th2020. Patients infected by SARS-CoV-2 virus and developing the COVID-19 disease with acute and severe respiratory symptoms have to be treated with mechanical ventilators to assure possibilities of survival.
世界衛(wèi)生組織(WHO)于2020年3月12日宣布COVID-19爆發(fā)。感染SARS-CoV-2病毒并發(fā)展成急性、嚴重呼吸道癥狀的患者必須使用呼吸機進行治療，以保證存活的可能性。
This guidance document focuses on ventilators and related accessories that are currently regulated under the Council Directive 93/42/EEC (MDD)1. According to the MDD, devices may be placed on the market and/or put into service only if they comply with the requirements laid down in this Directive when duly supplied and properly installed, maintained and used in accordance with their intended purpose2.
本指導(dǎo)文件重點介紹目前受歐盟理事會指令93/42 / EEC(MDD)監(jiān)管的呼吸機和相關(guān)配件。根據(jù)MDD，只要它們根據(jù)預(yù)期用途妥善提供，正確安裝、維護和使用符合指令的要求，就可以投放入市場和/或使用。
The devices must meet the essential requirements set out in Annex I of the MDD, which apply to them, taking account of the intended purpose of the devices concerned. In addition, devices may be placed and circulate on the European single market if they have been subject to a conformity assessment in accordance with the provisions of Article 11 of the MDD.
考慮到相關(guān)器械的預(yù)期用途，這些器械必須滿足MDD附件I中列出的基本要求。此外，如果器械已經(jīng)按照MDD第11條規(guī)定進行了合格評定，則可以在歐洲單一市場上出售和流通。
Under the current COVID-19 context, the demand for ventilators and related accessories has rapidly increased. Therefore, this document intends to outline the different regulatory options for placing these devices on the EU market indicating their feasibility to allow short-term supply.
在當(dāng)前COVID-19背景下，對呼吸機和相關(guān)配件的需求迅速增長。因此，本文檔旨在概述這些器械投放到歐盟市場的不同監(jiān)管選擇，表明短期供應(yīng)的可行性。
02
TYPES OF MEDICAL DEVICES AND THEIR PARTS/COMPONENTS
醫(yī)療器械及其零件、組件的分類
2.1.Ventilators
呼吸機
Ventilators are breathing support devices and can fall into different types according to their intended use and characteristics3:
呼吸機是呼吸支持器械，可根據(jù)其預(yù)期用途和特點分為以下三種類型：
-Ventilator for critical care: automatic equipment that is intended to augment or provide ventilation of the lungs of the patient when connected to the airway of the patient:
重癥監(jiān)護呼吸機：當(dāng)連接到患者的呼吸道時，旨在增強或提供患者肺部通氣的自動設(shè)備：
ointended for use in an environment that provides specialized care for patients whose conditions can be life threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility;
旨在為可能危及生命、需要全面護理，并需要在專業(yè)醫(yī)療機構(gòu)中進行持續(xù)監(jiān)控的患者提供專門護理的環(huán)境中使用;
ointended to be operated by a healthcare professional operator; and
旨在由醫(yī)療保健專業(yè)操作人員操作;和
ointended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.
適用于需要不同程度的人工通氣支持的患者，包括呼吸機依賴的患者。
(See e.g. EN ISO/IEC 80601-2-12:2011 + Cor.:2011).
- Home healthcare environment ventilators for ventilator-dependent patients: intended for use in the home healthcare environment; intended for use by a lay operator; intended for use with patients who are dependent on mechanical ventilation for their life support. Depending on the intended purpose can be also used in the clinical setting (See e.g. EN ISO 80601-2-72:2015).
對于依賴呼吸機的患者的家庭醫(yī)療保健呼吸機：用于家庭醫(yī)療環(huán)境;供非專業(yè)人員使用;適用于依靠機械通氣維持生命的患者。根據(jù)預(yù)期目的，也可以在臨床環(huán)境中使用。
-Ventilators for emergency and transport: these ventilators are used in Emergency Medical Service environment, e.g. in ambulances, transport of patients to the hospital, patient transport from hospital to hospital or transport within the hospital. The alarm and safety concept of emergency and transport ventilators in general is designed for a permanent presence of the user. This facilitates fast recognition and response in the event of an alarm or in the event of any malfunction (See e.g. EN 794-3:1998+A2:2009).
用于緊急情況和運輸?shù)暮粑鼨C：這類呼吸機用于緊急醫(yī)療服務(wù)環(huán)境，如在救護車中，將病人運送到醫(yī)院，將病人從醫(yī)院運送到醫(yī)院或在醫(yī)院內(nèi)運送。通常，用于緊急情況和運輸?shù)暮粑鼨C的警報和安全概念是為使用者的永久存在而設(shè)計的。這有助于在發(fā)生警報或發(fā)生任何故障時快速識別和反應(yīng)。
-Anaesthetic ventilator: are designed for use during anaesthesia with an anaesthetic breathing system (See e.g. EN ISO 80601-2-13:2012)
麻醉呼吸機：為通過呼吸系統(tǒng)麻醉而設(shè)計
Ventilators for critical care are usually invasive, which enables the ventilator machine to provide lung support for inspiration and expiration through tracheal intubation. However, most critical care ventilators allow non-invasive ventilation modes for critical care patients as well. Ventilators for non-critical care are usually non-invasive and therefore provide air pressure support to natural breathing through e.g. a facemask.
用于重癥監(jiān)護的呼吸機通常是侵入式的，這使呼吸機能夠通過氣管插管為吸氣和呼氣提供肺部支持。但是，大多數(shù)重癥監(jiān)護呼吸機也允許重癥監(jiān)護患者使用無創(chuàng)通氣模式。用于非重癥監(jiān)護的呼吸機通常是非侵入性的，因此可以為自然呼吸提供氣壓支持，如通過面罩。
Ventilators may offer different types of additional complementary functions that include:
呼吸機可能提供不同類型的其它補充功能，包括：
□High flow oxygen supply (nasal high flow therapy);
□Monitoring systems;
□Nebulisation systems.
□高流量供氧(鼻高流量氧療);
□監(jiān)控系統(tǒng);
□霧化系統(tǒng)。
2.2.Accessories
配件
Ventilators need to be “connected” to the patients through dedicated accessories4 to the ventilator that allow the machine to support the patient’s breathing; therefore, it is important to proof compatibility with the ventilator(s). These accessories can be placed on the market individually and usually fall into one of the following categories:
呼吸機需要通過專門的配件與患者“連接”，使機器幫助患者的呼吸。因此，配件是否能與呼吸機兼容尤為重要。這些配件可以單獨投入市場，通常屬于以下類別之一：
□Breathing systems and circuits, such as:
呼吸系統(tǒng)和線路，如：
o Circuits;
線路
o Connections/Adapters;
連接件/適配器
o Tubes;
管路
o Nasal cannulas for O2;
氧氣鼻導(dǎo)管
o Masks or helmets for non-invasive ventilation;
無創(chuàng)呼吸頭盔或面罩
o Air compressors;
空氣壓縮機
□Nebulizers;
霧化器;
□Humidifiers and filters;
加濕器和過濾器;
□Monitoring accessories, including alarms, in-built safety features.
監(jiān)控附件，包括警報、內(nèi)置的安全功能。
Accessories are provided either disposable or reusable and are treated as medical devices in their own right5.
提供的配件既可以是一次性使用的也可以是重復(fù)使用的，并且其本身就被視為醫(yī)療器械。
2.3.Parts or components
零件或組件
Parts or components of medical devices that do not qualify as accessories are generally not considered medical devices and thus not requiring themselves to be CE marked according to the MDD (e.g. expiratory valves or flow sensors).
不符合配件條件的醫(yī)療器械零件或組件通常不被視為醫(yī)療器械，因此不需要根據(jù)MDD(例如呼氣閥或流量傳感器)對其進行CE標記。
03
CLASSIFICATION
分類
3.1.Ventilators
呼吸機
There are different types of ventilators depending on the degree of invasiveness and the setting in which they are used in (e.g. Intensive Care Unit - ICU). Ventilators fall under two different classes in accordance with rule 11 (or rule 9) of Annex IX6,7 to the MDD:
呼吸機的類型取決于侵入程度和使用的環(huán)境(例如重癥監(jiān)護病房-ICU)。根據(jù)MDD附件IX條例11(或條例9)，呼吸機分為兩個不同的類別：
-Class IIa: only applicable to non-invasive devices, e.g. continuous positive airway pressure – CPAP non-intended for critical care, or devices that only support spontaneous breathing.
IIa類：僅適用于非侵入式器械，例如，持續(xù)氣道正壓(CPAP)不適用于重癥監(jiān)護，或僅支持自發(fā)呼吸的器械。
-Class IIb: applicable to most ventilators.
IIb類：適用于大多數(shù)呼吸機
The classification depends on the intended purpose of the ventilator and has important implications in the selection of appropriate conformity assessment procedure(s) for the device including timing and complexity (see section 4 for details).
分類取決于呼吸機的預(yù)期用途，并且在為器械選擇適當(dāng)?shù)暮细裨u定程序方面具有重要意義(有關(guān)詳細信息，請參見第4節(jié))。
3.2.Accessories
配件
Accessories are classified in their own right usually in accordance with rule 2 or 5 of Annex IX to the MDD, under Class I, IIa or IIb.
配件通常根據(jù)MDD附件IX的條例2或5在I，IIa或IIb類下按其本身分類。
3.3.Impact of classification on conformity assessment
分類對合規(guī)評定的影響
Given that ventilators are classified as Class IIa or Class IIb, and accessories (except for Class I non-sterile and without measuring function), will in principle need the involvement of a notified body prior to their placing on the market. Other options for the placing on the market are provided in section 4 for both ventilators and accessories.
鑒于呼吸機被分類為IIa類或IIb類(包括除I類非無菌且不具備測量功能之外的配件)，原則上需要公告機構(gòu)在其投入市場前參與。第4部分為呼吸機和配件投放市場提供了其它選項。
04
REGULATORY OPTIONS FOR PLACING VENTILATORS ON THE MARKET
呼吸機上市的法規(guī)選項
In the context of the COVID-19 outbreak, several industries have expressed their willingness to support and scale up the production of ventilators8. There are different regulatory options9 available for supporting production or placing on the market of ventilators. These options are presented below, ordered by feasibility, to allow a swift supply in the current context.
在COVID-19爆發(fā)的背景下，一些行業(yè)愿意支持和擴大呼吸機的生產(chǎn)。有不同的法規(guī)選擇可用于支持呼吸機的生產(chǎn)或投放市場。下面列出并按可行性排列了這些選項。
4.1.Supplying parts, components or the finished devices to medical devices manufacturers currently placing on the market ventilators
向目前投放市場呼吸機的制造商提供零件，組件或成品器械
When the legal manufacturer10 has already undergone a conformity assessment for the ventilator, has obtained a certificate and is lawfully placing ventilators on the market under its own name, other producers (e.g. not currently working in the medical devices field) can support its production. Such producers can provide parts or components, or the finished device, therefore becoming suppliers or subcontractors of this manufacturer.
當(dāng)合法制造商已對呼吸機進行合格評定，獲得認證并合法地以自己的名義將呼吸機投放市場時，其他生產(chǎn)商(例如當(dāng)前不涉及醫(yī)療器械領(lǐng)域生產(chǎn)商)可以支持其生產(chǎn)。這樣的生產(chǎn)商可以提供零件或組件，或者成品器械，成為該制造商的供應(yīng)商或分包商。
Given that the medical devices sector is highly regulated and complex, leveraging the knowledge and responsibilities of an already established manufacturer of ventilators could be the least burdensome and fastest option to scale up the production of ventilators.
鑒于醫(yī)療器械行業(yè)受到高度監(jiān)管和其復(fù)雜性，因此，依靠已經(jīng)建立知識和職責(zé)的呼吸機制造商，是擴大呼吸機生產(chǎn)規(guī)模的負擔(dān)最小，最快的選擇。
4.1.1.Producers supplying parts or components to medical devices manufacturers currently placing on the market ventilators
生產(chǎn)商向目前投放市場的呼吸機的醫(yī)療器械制造商供應(yīng)零件或組件
Manufacturers of medical devices can have many suppliers, which in case of quality system certification are qualified, approved and controlled by the manufacturer. These suppliers may need to be assessed by a notified body as part of the conformity assessment procedure on the basis of their criticality and the manufacturer’s process in place to control suppliers and the verification of purchased products11. When the manufacturer wishes to use an additional supplier, this might need to be communicated in advance to the notified body.
醫(yī)療器械制造商可以有多家供應(yīng)商，在質(zhì)量體系認證的情況下，這些供應(yīng)商是合格的，且由制造商認可和控制的。這些供應(yīng)商可能需要公告機構(gòu)對它們進行評估，作為基于制造商控制供應(yīng)商的流程，以及所買產(chǎn)品的驗證的合格評定程序的一部分。如果制造商希望使用其它供應(yīng)商，則要事先通知公告機構(gòu)。
4.1.2. Producers manufacturing the ventilator itself for the medical device manufacturer currently placing on the market ventilators
為目前投放市場的呼吸機制造商制造呼吸機的生產(chǎn)商
Manufacturers of medical devices producing ventilators may provide the specifications of a ventilator (e.g. current or older/simpler design) including parts of the technical documentation to a producer that becomes its subcontractor. The producer will manufacture the ventilator but the medical device manufacturer will keep its role of legal manufacturer according to the MDD.
生產(chǎn)呼吸機的醫(yī)療器械制造商可以向成為其分包商的生產(chǎn)商提供呼吸機的規(guī)格(如，當(dāng)前或更早版本/更簡單的設(shè)計)，包括技術(shù)文檔的一部分。生產(chǎn)商將可以制造呼吸機，但醫(yī)療器械制造商需根據(jù)MDD保持其合法制造商的角色。
The legal manufacturer of the ventilator, which holds a quality system certification, qualifies, approves and controls the subcontractor that will need to be assessed by a notified body as part of the conformity assessment procedure. When the manufacturer wishes to use an additional subcontractor, this will need to be communicated in advance to the notified body (i.e. as the subcontractor is considered critical11) that will assess the available information and will decide the actions to be put in place e.g. whether or not it is necessary to carry out an (on-site12) audit.
呼吸機的合法制造商持有的質(zhì)量體系認證，對分包商進行資格認證、批準和控制，將作為合格評定程序的一部分，該分包商需要由公告機構(gòu)進行評估。當(dāng)制造商希望使用其它的分包商時，需要事先通知公告機構(gòu)，該機構(gòu)將評估可用信息并決定將采取的措施，例如是否有必要進行(現(xiàn)場)審核。
Alternatively, the manufacturer of medical devices could also follow other conformity assessment routes such as the EC type-examination, as established in Annex III to the MDD, and/or EC verification, as established in Annex IV to the MDD (these routes are elaborated in 4.3.2).
或者，醫(yī)療器械制造商也可以遵循其他合格評定途徑，例如MDD附件III中確定的EC類型檢查和/或MDD附件IV中確定的EC驗證(在4.3.2中詳細說明了這些路徑)。
4.2.Derogation procedure – placing on the market authorised by the relevant authorities of one Member State in the interest of public health
簡單上市（Derogation）程序–一個成員國的有關(guān)部門因公共健康利益而授權(quán)投放市場
The relevant authority of one Member State may decide to authorise the placing on the market of devices in the interest of protection of health, even if the applicable conformity assessment procedures have not been finalised or initiated ('national derogation').
即使尚未最終確定或未啟動適用的合格評定程序，一個成員國的有關(guān)當(dāng)局仍可決定授權(quán)將器械投放市場以保護公共健康。
In view of the epidemiological context as well as the exponential growth in demand for medical devices, the Commission has published a Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the Covid-19 context.
考慮到流行病背景以及對醫(yī)療器械需求的指數(shù)級增長，委員會發(fā)布了《Covid-19環(huán)境下的醫(yī)療器械、有源植入式醫(yī)療器械和體外診斷醫(yī)療器械指南》。
Question 5 of this guidance provides information on the derogation procedures for medical devices which is established in Article 11(13) of the MDD. In particular, the guidance specifies that the Covid-19 context warrants the application of such derogations.
該指南的問題5提供了有關(guān)MDD第11(13)條規(guī)定的醫(yī)療器械簡單上市程序的信息，指南在Covid-19背景下應(yīng)保證此類簡單上市的適用。
By amendment of 23 April 202013, Article 59(1) of Medical Devices Regulation (EU) 2017/745 (MDR) empowers Member States to adopt national derogations under both the MDD and the MDR from the date of entry into force of that amendment.
《醫(yī)療器械法規(guī)》(EU)2017/745(MDR)第59(1)條于2020年4月23日作出修訂，授權(quán)成員國自該修正案生效之日起根據(jù)MDD和MDR采取簡單上市。
The relevant competent authority of the Member State in this case authorises the placing on the market within its territory and can also organise the purchase.
在這種情況下，成員國的相關(guān)主管當(dāng)局可授權(quán)在其國家內(nèi)投放市場，也可以組織購買。
In practice, this implies that each competent authority would need to assess whether the products produced by the manufacture provides an adequate level of safety in respect to the applicable legal requirements. The assessment procedures can vary among Member States and in some cases will involve the support of third parties (e.g. testing laboratories).
實際上，這意味著每個主管當(dāng)局都需要評估制造商生產(chǎn)的產(chǎn)品是否在適用的法律要求方面提供了足夠的安全水平。評估程序可能因成員國而異，在某些情況下還需要第三方(如檢測實驗室)的支持。
In the exceptional COVID-19 context, the assessment procedures will ensure a short- term supply while guaranteeing patient safety14. The Member State will evaluate the available technical documentation to find evidence that essential performance and safety requirements are guaranteed in the context of use. In particular, the role of healthcare teams and health facilities is essential to allow a rational use and a continuous assessment of these crisis solutions.
在特殊的COVID-19環(huán)境中，評估程序?qū)⒃诖_?；颊甙踩耐瑫r保證短期的供應(yīng)。成員國將評估可用的技術(shù)文檔，以找到證據(jù)證明在使用過程中可以保證基本性能和安全要求。醫(yī)療團隊和醫(yī)療機構(gòu)的作用對于合理使用和持續(xù)評估危險至關(guān)重要。
Once this assessment is performed, the authority has to take a decision, whether or not the respective device produced by the manufacturer may enter the national territory of the Member State. Competent authorities should inform the Commission and their counterparts in other Member States of any temporary agreement they have granted to specific devices.
評估完成后，主管部門必須做出決定，制造商生產(chǎn)的相應(yīng)器械是否可以進入成員國的本國領(lǐng)土。主管當(dāng)局應(yīng)將它們已授予特定器械的所有臨時協(xié)議通知委員會及其其它成員國的對口單位。
In addition, Article 59(3) of the MDR empowers the Commission to extend, in exceptional cases relating to public health or patient safety or health, by means of implementing acts, for a limited period of time the validity of a national derogation, granted by a Member State under the MDD or the MDR, to the territory of the Union and set the conditions under which a device may be placed on the market or put into service. This allows the Commission and the Member States to address potential shortages Union wide of vitally important medical devices in an effective manner.
此外，MDR第59(3)條授權(quán)歐盟委員會在與公共衛(wèi)生或患者安全或健康有關(guān)的特殊情況下，可以通過實施法案在有限的時間內(nèi)將國家“簡單上市”的效力延長。由成員國根據(jù)MDD或MDR移至歐盟領(lǐng)域，并設(shè)定器械可投放市場或投入使用的條件。這使委員會和成員國能夠有效地解決潛在的醫(yī)療器械短缺。
Timing to obtain a national derogation by a competent authority will greatly depend on the quality and adequacy of the evidence provided by the manufacturer. When technical documentation and evidence of safety of performance is adequate, this can be a feasible option to ensure short-term supply.
由主管當(dāng)局獲得國家“簡單上市”的時間將在很大程度上取決于制造商提供的證據(jù)的質(zhì)量和充分性。技術(shù)文件和性能安全的證據(jù)充分，是確保短期供應(yīng)的可行選擇。
4.3.Manufacturing of the finished device by a producer that was not previously placing on the market ventilators
由先前未投放市場的生產(chǎn)商制造成品器械
If the ventilator is entirely manufactured by a producer that decides to place it on the market under its name, such producer will become the legal manufacturer in its own right. This means that the manufacturer will need to fulfil all requirements of the MDD (e.g. including the need to draw up the technical documentation and clinical evaluation related to the ventilator, and to establish and keep up to date a systematic procedure to review experience gained from devices in the post-production phase).
如果呼吸機完全由一個決定以其自己名義投放市場的生產(chǎn)商制造，該生產(chǎn)商將以其自身的權(quán)利成為合法制造商。這意味著此制造商需要滿足MDD的所有要求(例如，需要起草與呼吸機相關(guān)的技術(shù)文件和臨床評價，以及建立并保持最新的系統(tǒng)程序來回顧在生產(chǎn)后階段從器械中獲得的經(jīng)驗)。
The manufacturer who places the finished CE marked ventilator on the market under its own name needs to ensure that the device complies with the essential requirements (established in Annex I of the MDD) and provide relevant evidence. A notified body will be involved in the conformity assessment in all cases.
以自己的名義向市場投放有CE標志的成品呼吸機的制造商需要確保器械符合基本要求(MDD附錄I中規(guī)定)并提供相關(guān)證據(jù)。在所有情況下，公告機構(gòu)都將參與合格評定。
Given that the medical devices sector is highly regulated and complex, the scenarios presented below will be the most burdensome and therefore only applicable to increase supply in the medium-long term.
鑒于醫(yī)療器械行業(yè)監(jiān)管嚴格及其復(fù)雜性，下文所述情景將是最繁重的，僅適用于增加中長期的供應(yīng)。
4.3.1. Medical devices manufacturers’ not currently producing ventilators request an extension of their product range.
當(dāng)前沒有未生產(chǎn)呼吸機醫(yī)療器械制造商，要求擴展他們的產(chǎn)品范圍
This option is available for medical devices manufacturers currently certified. It includes, for instance, medical devices manufacturers already holding a full quality management system certificate under Annex II to the MDD for other devices and wishing to add ventilators to their certification. They could seek the support from (non-medical devices) producers to act as subcontractors and extend the scope of their certificate.
此選項適用于當(dāng)前已認證的醫(yī)療器械制造商。例如，包括已經(jīng)根據(jù)MDD附件II持有針對其它器械的完整質(zhì)量管理體系證書，并且希望在其認證中增加呼吸機的醫(yī)療器械制造商。他們可以尋求(非醫(yī)療器械)生產(chǎn)商的作為分包商并擴展其認證的范圍。
From a procedural point of view, the medical devices manufacturer may produce the ventilator itself or may utilise a subcontractor (i.e. producer linked or not to the medical devices field). In the latter case, the manufacturer will qualify, approve and control the subcontractor that will be assessed by the notified body as part of the conformity assessment procedure. When the manufacturer wishes to use an additional subcontractor, this will need to be communicated in advance to the notified body (i.e. as the subcontractor is considered critical11) that will assess the available information and will decide the actions to be put in place e.g. whether or not it is necessary to carry out an (on- site12) audit.
從程序的角度看，醫(yī)療器械制造商可以自己生產(chǎn)呼吸機，也可以利用分包商(即與醫(yī)療器械領(lǐng)域有關(guān)聯(lián)或沒有關(guān)聯(lián)的生產(chǎn)商)。在后一種情況下，制造商將認證、批準和控制由公告機構(gòu)評估的分包商，作為合格評定程序的一部分。當(dāng)制造商希望使用額外的分包商時，需要事先通知公告機構(gòu)，該機構(gòu)將評估信息并將采取的措施，例如 是否有必要進行審核。
Most importantly, the manufacturer will need to request an extension of the product range from its notified body. The notified body will assess the available information in relation to the new product (that include an assessment of the technical documentation and clinical evaluation) and update the certificate.
最重要的是，制造商將需要從其公告機構(gòu)那申請擴展產(chǎn)品范圍。公告機構(gòu)將評估與新產(chǎn)品有關(guān)的信息(包括對技術(shù)文檔和臨床評價的評估)并更新認證。
The manufacturer of medical devices could also use other conformity assessment routes such as the EC Type-Examination and EC Verification and testing of every product under Annex III and IV respectively (these routes are elaborated in section 4.3.2).
醫(yī)療器械制造商還可以使用其它合格評定途徑，例如分別根據(jù)附件III和IV對每種產(chǎn)品進行EC類型檢查和EC驗證以及測試(這些途徑在4.3.2部分中進行了詳細說明)。
4.3.2.Ventilator manufactured entirely by a producer that is not currently a legal manufacturer under the MDD
完全由目前不是MDD合法制造商的生產(chǎn)商制造的呼吸機
Producers that do not currently qualify as legal manufacturers under the MDD and decide to place ventilators on the market under their own name need to be aware of all the legal requirements for manufactures under the MDD. It is important to mention that in the field of medical devices some Member States could have additional requirements, for instance, the need to authorise the facility of the medical device manufacturer prior to starting production.
當(dāng)前MDD下未能成為合法制造商并決定以自己的名義將呼吸機投放市場的生產(chǎn)商需要了解MDD下制造商的所有法律要求。值得一提的是，在醫(yī)療器械領(lǐng)域，一些成員國可能有其他要求，例如，在開始生產(chǎn)之前需要對醫(yī)療器械制造商的設(shè)施進行授權(quán)。
In addition to this, the involvement of a notified body will depend on the classification. In particular:
除此之外，公告機構(gòu)的參與將取決于分類。特別是：
1.Class IIa ventilators can follow the following routes established in the relevant Annexes of the MDD:
IIa 類呼吸機可以遵循MDD相關(guān)附件中確定的以下途徑
a.Annex II (excluding point 4) – which involves the assessment of the full manufacturer’s quality management system. This will require an on-site audit (which may be performed remotely in the current context) andregular surveillance audits at least annually. In addition, the notified body will assess the technical documentation and the clinical evaluation of the product to be certified prior to certification on a sampling basis15.
附件II(第4點除外)–涉及對制造商整個的質(zhì)量管理體系的評估。這將需要至少每年一次的現(xiàn)場審核(在當(dāng)前情況下可以遠程執(zhí)行)和定期的監(jiān)督審核。此外，公告機構(gòu)將在認證前的進行產(chǎn)品技術(shù)文檔評估和臨床評價評估。
b.Declaration of conformity (Annex VII) combined with either an assessment of the quality assurance of the production or of the product (Annex V or VI) or a EC verification (set out in Annex IV):
符合性聲明(附件VII)與生產(chǎn)或產(chǎn)品質(zhì)量保證評估(附件V或VI)或EC驗證(附件IV中列出)相結(jié)合：
□The assessment of the quality system performed by the notified body will be similar to the one outlined in section 1.a above.
公告機構(gòu)對質(zhì)量體系的評估將與上文第1.a部分概述的評估類似。
□The verification by testing of products by the notified body will be performed by examination and testing of every product.
公告機構(gòu)對產(chǎn)品測試的驗證將通過檢查和測試每個產(chǎn)品來進行。
2.Class IIb ventilators can follow the following routes:
IIa 類呼吸機可以遵循以下途徑
a. Annex II (excluding point 4) – which involves the assessment of the full manufacturer’s quality management system. This will require an on-site audit (which may be performed remotely in the current context) and regular surveillance audits at least annually. In addition, the notified body will assess the technical documentation and the clinical evaluation of the products to be certified prior to certification on a sampling basis15.
附件二(第4點除外)–涉及對整個制造商的質(zhì)量管理體系的評估。這將需要至少每年一次的現(xiàn)場審核(在當(dāng)前情況下可以遠程執(zhí)行)和定期的監(jiān)督審核。此外，公告機構(gòu)將在認證前的進行產(chǎn)品技術(shù)文檔評估和臨床評價評估。
b.EC type-examination (Annex III) combined with either an assessment of the quality assurance either of the production or of the product (Annex V or VI) or EC verification by testing of products (set out in Annex IV). EC Type-examination consists in the assessment of the technical documentation and testing of a number of features of the device type to ensure it conforms to the requirements. The additional procedures (Annex IV, V or VI) are the same as the ones described in 1.b above.
EC類型檢查(附件III)與生產(chǎn)或產(chǎn)品的質(zhì)量保證的評估(附件V或VI)或通過對產(chǎn)品的測試進行EC驗證相結(jié)合(見附件IV)。EC類型檢查包括評估技術(shù)文檔和測試器械類型的多個功能，以確保其符合要求。附加程序(附件IV，V或VI)與上述1.b中描述的程序相同。
The assessment of the quality management system of the manufacturer (Annex II, V andVI) can be partly fulfilled by compliance with a harmonised standard (EN ISO 13485) but this route will unlikely be fast enough to ensure short-term supply. This is due to the timelines and experience required to get a certificate under these annexes of the MDD and taking into account the current circumstances where auditing capacity is restricted by the Covid19 situation.
可以通過遵守統(tǒng)一標準(EN ISO 13485)來完成對制造商質(zhì)量管理體系(附件II，V和VI)的部分評估，根據(jù)MDD的相關(guān)附件獲得證書所需的時間和經(jīng)驗，并考慮到當(dāng)前Covid19情況限制了審查能力，這種方法不能迅速地確保短期供應(yīng)。。
A faster route but also time-consuming route will probably be the performance of tests on the products that might be combined with the assessment of the technical documentation, namely:
一個更方便但更耗時的途徑可能是將產(chǎn)品的性能測試與技術(shù)文檔的評估相結(jié)合，即：
-declaration of conformity (Annex VII) + verification of products (Annex IV) for Class IIa; or
IIa的類符合性聲明(附件VII)+產(chǎn)品驗證(附件IV);或
- EC type-examination (Annex III) + verification of products (Annex IV) for Class IIb.
IIb類的EC類型檢驗(附件III)+產(chǎn)品驗證(附件IV)。
Through this route, the device type or device samples are tested and there is no obligation to have a certified quality management system in place and subject to regular surveillance audits. However, quality management processes are important and critical to the production of safe and functional medical devices. The conformity assessment will be based on the manufacturers testing strategy that must ensure compliance with the safety and performance requirements.
通過此途徑，將對器械類型或器械樣本進行測試，并且沒有義務(wù)建立經(jīng)過認證的質(zhì)量管理體系并接受定期的監(jiān)督審核。但是，質(zhì)量管理過程對于生產(chǎn)安全且功能齊全的醫(yī)療器械至關(guān)重要。合格評定將基于制造商的必須符合安全和性能測試策略。
It should be noted that this option is burdensome and will take several months, especially to draw up an adequate technical documentation. In addition, there is only a limited number of notified bodies designated to perform EC type-examination and/or EC verification in ventilators (according to NANDO16 18 notified bodies out of 56 are authorised to perform these tests at the moment).
應(yīng)當(dāng)指出，這種選擇及其麻煩，且需要數(shù)個月的時間，尤其是要準備一份合格的技術(shù)文檔。此外，只有少數(shù)指定的公告機構(gòu)可以在呼吸機中執(zhí)行EC類型檢查和/或EC驗證(根據(jù)NANDO16的規(guī)定，目前56個公告機構(gòu)中有18個公告機構(gòu)可以執(zhí)行這些測試)。
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13
下一篇：【收藏】中國器審答疑最全匯總！
? 2018 - 2020, Wuhan Tacro Technology Co.，Ltd All Rights Reserved.
