product or trade name and a general description of the device including its intended purpose and intended users;產品或商品名稱以及設備的一般說明，包括其預定用途和預定用戶；

(b)

the Basic UDI-DI as referred to in Part C of Annex VI assigned by the manufacturer to the device in question, as soon as identification of this device becomes based on a UDI system, or otherwise a clear identification by means of product code, catalogue number or other unambiguous reference allowing traceability;一旦該設備的標識基於UDI系統，則由製造商分配給該設備的附件VI的C部分中所指的基本UDI-DI，或者通過產品代碼，目錄的明確標識編號或其他明確的參考文獻，可追溯；

(c)

the intended patient population and medical conditions to be diagnosed, treated and/or monitored and other considerations such as patient selection criteria, indications, contra-indications, warnings;要診斷，治療和/或監視的預期患者人群和醫療狀況，以及其他考慮因素，例如患者選擇標準，適應症，禁忌症，警告；

(d)

principles of operation of the device and its mode of action, scientifically demonstrated if necessary;設備的工作原理及其作用方式，必要時進行科學證明；

(e)

the rationale for the qualification of the product as a device;產品作為設備合格的理由；

(f)

the risk class of the device and the justification for the classification rule(s) applied in accordance with Annex VIII;設備的風險等級以及根據附件八適用的分類規則的理由；

(g)

an explanation of any novel features;對任何新穎特徵的解釋；

(h)

a description of the accessories for a device, other devices and other products that are not devices, which are intended to be used in combination with it;設備附件，其他設備以及不是設備的其他產品的說明，這些附件旨在與之結合使用；

(i)

a description or complete list of the various configurations/variants of the device that are intended to be made available on the market;打算在市場上出售的設備的各種配置/變量的描述或完整列表；

(j)

a general description of the key functional elements, e.g. its parts/components (including software if appropriate), its formulation, its composition, its functionality and, where relevant, its qualitative and quantitative composition. Where appropriate, this shall include labelled pictorial representations (e.g. diagrams, photographs, and drawings), clearly indicating key parts/components, including sufficient explanation to understand the drawings and diagrams;關鍵功能元素的一般說明，例如它的零件/組件（如果適用，還包括軟件），其配方，其組成，功能以及（如果相關）其定性和定量組成。在適當情況下，應包括帶標籤的圖形表示（例如，圖表，照片和繪圖），清楚地表明關鍵部件/組件，包括足夠的解釋以理解附圖和圖表；

(k)

a description of the raw materials incorporated into key functional elements and those making either direct contact with the human body or indirect contact with the body, e.g., during extracorporeal circulation of body fluids;對包含在關鍵功能元件中的原材料以及與人體直接接觸或與人體間接接觸的原材料的描述，例如在體液的體外循環過程中;

(l)

technical specifications, such as features, dimensions and performance attributes, of the device and any variants/configurations and accessories that would typically appear in the product specification made available to the user, for example in brochures, catalogues and similar publications.設備的技術規格，例如功能，尺寸和性能屬性，以及通常會出現在提供給用戶的產品規格中的任何變型/配置和附件，例如在手冊，目錄和類似出版物中。

an overview of the previous generation or generations of the device produced by the manufacturer, where such devices exist;存在設備的製造商生產的設備的前幾代的概述；

(b)

an overview of identified similar devices available on the Union or international markets, where such devices exist.概述已存在的聯盟或國際市場上已找到的類似設備。

the label or labels on the device and on its packaging, such as single unit packaging, sales packaging, transport packaging in case of specific management conditions, in the languages accepted in the Member States where the device is envisaged to be sold; and設備及其包裝上的一個或多個標籤，例如在特定管理條件下的單件包裝，銷售包裝，運輸包裝，應使用擬出售該設備的成員國所接受的語言；和

—

the instructions for use in the languages accepted in the Member States where the device is envisaged to be sold.打算出售該設備的成員國所接受的語言中的使用說明。

information to allow the design stages applied to the device to be understood;允許理解應用於設備的設計階段的信息；

(b)

complete information and specifications, including the manufacturing processes and their validation, their adjuvants, the continuous monitoring and the final product testing. Data shall be fully included in the technical documentation;完整的信息和規格，包括製造過程及其驗證，佐劑，持續監控和最終產品測試。數據應完全包含在技術文檔中；

(c)

identification of all sites, including suppliers and sub-contractors, where design and manufacturing activities are performed.識別進行設計和製造活動的所有站點，包括供應商和分包商。

the general safety and performance requirements that apply to the device and an explanation as to why others do not apply;適用於該設備的一般安全和性能要求，以及為何不適用其他要求的解釋；

(b)

the method or methods used to demonstrate conformity with each applicable general safety and performance requirement;用於證明符合每個適用的一般安全和性能要求的方法；

(c)

the harmonised standards, CS or other solutions applied; and所採用的協調標準，CS或其他解決方案；和

(d)

the precise identity of the controlled documents offering evidence of conformity with each harmonised standard, CS or other method applied to demonstrate conformity with the general safety and performance requirements. The information referred to under this point shall incorporate a cross-reference to the location of such evidence within the full technical documentation and, if applicable, the summary technical documentation.受控文件的準確身份，提供符合每個統一標準，CS或其他方法的證據，以證明其符合一般安全和性能要求。 在這一點上提到的信息應在完整的技術文檔和摘要技術文檔（如果適用）中包含對此類證據位置的交叉引用。

the benefit-risk analysis referred to in Sections 1 and 8 of Annex I, and附件一第1節和第8節中提到的收益風險分析，以及

(b)

the solutions adopted and the results of the risk management referred to in Section 3 of Annex I.附件一第3節中所採用的解決方案和風險管理的結果。

results of tests, such as engineering, laboratory, simulated use and animal tests, and evaluation of published literature applicable to the device, taking into account its intended purpose, or to similar devices, regarding the pre-clinical safety of the device and its conformity with the specifications;測試的結果，例如工程，實驗室，模擬用途和動物測試，以及考慮到設備的預期用途或類似設備的有關臨床前安全性和合格性的評估，適用於該設備的已發表文獻符合規格；

detailed information regarding test design, complete test or study protocols, methods of data analysis, in addition to data summaries and test conclusions regarding in particular:有關測試設計，完整的測試或研究方案，數據分析方法的詳細信息，以及有關以下內容的數據摘要和測試結論：

Where applicable, conformity with the provisions of Directive 2004/10/EC of the European Parliament and of the Council (1) shall be demonstrated.
Where no new testing has been undertaken, the documentation shall incorporate a rationale for that decision. An example of such a rationale would be that biocompatibility testing on identical materials was conducted when those materials were incorporated in a previous version of the device that has been legally placed on the market or put into service;如果適用，應證明符合歐洲議會和理事會第2004/10 / EC號指令（1）的規定。
 如果沒有進行新的測試，則文件應包含該決定的理由。這種原理的一個例子是，當將相同材料摻入已合法投放市場或投入使用的設備的先前版本中時，就對這些材料進行了生物相容性測試；

(c)

the clinical evaluation report and its updates and the clinical evaluation plan referred to in Article 61(12) and Part A of Annex XIV;第61條第（12）款和附件XIV的A部分提到的臨床評估報告及其更新和臨床評估計劃;

(d)

the PMCF plan and PMCF evaluation report referred to in Part B of Annex XIV or a justification why a PMCF is not applicable.附件十四B部分提到的PMCF計劃和PMCF評估報告，或不適用PMCF的理由。

Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, as referred to in the first subparagraph of Article 1(8), a statement indicating this fact. In this case, the documentation shall identify the source of that substance and contain the data of the tests conducted to assess its safety, quality and usefulness, taking account of the intended purpose of the device.當器械包含作為整體組成部分的物質時，如果單獨使用該物質，則可能被視為指令2001/83 / EC第1條第2款含義內的藥物，包括源自人的藥物第1條第（8）款第1項所指的血液或人體血漿的聲明表明了這一事實。在這種情況下，文檔應標識該物質的來源，並包含為評估其安全性，質量和有用性而進行的測試數據，並考慮到設備的預期用途。

(b)

Where a device is manufactured utilising tissues or cells of human or animal origin, or their derivatives, and is covered by this Regulation in accordance with points (f) and (g) of Article 1(6, and where a device incorporates, as an integral part, tissues or cells of human origin or their derivatives that have an action ancillary to that of the device and is covered by this Regulation in accordance with the first subparagraph of Article 1(10), a statement indicating this fact. In such a case, the documentation shall identify all materials of human or animal origin used and provide detailed information concerning the conformity with Sections 13.1. or 13.2., respectively, of Annex I.如果器械是利用人類或動物來源的組織或細胞或其衍生物製造的，並且根據第1條第（6）款（f）和（g）的規定被本法規涵蓋，並且該器械以具有附屬於該裝置的動作的，人體活動的整體部分，組織或細胞或其衍生物，並根據第1條第（10）款的第一小節在本法規中予以涵蓋，並聲明表明了這一事實。在這種情況下，文件應標識所使用的所有人類或動物來源的材料，並分別提供有關分別符合附件一第13.1節或第13.2節的詳細信息。

(c)

In the case of devices that are composed of substances or combinations of substances that are intended to be introduced into the human body and that are absorbed by or locally dispersed in the human body, detailed information, including test design, complete test or study protocols, methods of data analysis, and data summaries and test conclusions, regarding studies in relation to:如果設備由旨在引入人體並被人體吸收或局部分散在人體中的物質或物質組合組成，則詳細信息，包括測試設計，完整的測試或研究方案，有關以下方面的研究的數據分析方法，數據摘要和測試結論：

In the absence of such studies, a justification shall be provided.在沒有進行此類研究的情況下，應提供理由。

(d)

In the case of devices containing CMR or endocrine-disrupting substances referred to in Section 10.4.1 of Annex I, the justification referred to in Section 10.4.2 of that Annex.對於包含附件一第10.4.1節中提及的CMR或破壞內分泌的物質的器械，該附件第10.4.2節中提及的理由。

(e)

In the case of devices placed on the market in a sterile or defined microbiological condition, a description of the environmental conditions for the relevant manufacturing steps. In the case of devices placed on the market in a sterile condition, a description of the methods used, including the validation reports, with respect to packaging, sterilisation and maintenance of sterility. The validation report shall address bioburden testing, pyrogen testing and, if applicable, testing for sterilant residues.對於以無菌或確定的微生物條件投放市場的設備，請描述相關製造步驟的環境條件。對於以無菌狀態投放市場的設備，應說明所用方法的說明，包括有關包裝，滅菌和保持無菌狀態的驗證報告。確認報告應涉及生物負荷測試，熱原測試以及（如果適用）滅菌殘留物測試。

(f)

In the case of devices placed on the market with a measuring function, a description of the methods used in order to ensure the accuracy as given in the specifications.對於投放市場的具有測量功能的設備，為了確保規格中給出的準確性而使用的方法的說明。

(g)

If the device is to be connected to other device(s) in order to operate as intended, a description of this combination/configuration including proof that it conforms to the general safety and performance requirements when connected to any such device(s) having regard to the characteristics specified by the manufacturer.如果要將設備連接到其他設備以按預期進行操作，則此組合/配置的說明應包括證明在連接到任何此類設備時符合常規安全性和性能要求的證明達到製造商指定的特性。