CHAPTER I
SCOPE AND DEFINITIONS
Article 1
Subject matter and scope
1. This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union. This Regulation also applies to clinical investigations concerning such medical devices and accessories conducted in the Union.本法規規定了有關在國際市場上投放市場，在市場上出售或投入使用的醫療器械以及這些器械的附件的規則。本法規也適用於在聯盟中進行的有關此類醫療器械和附件的臨床研究。
2. This Regulation shall also apply, as from the date of application of common specifications adopted pursuant to Article 9, to the groups of products without an intended medical purpose that are listed in Annex XVI, taking into account the state of the art, and in particular existing harmonised standards for analogous devices with a medical purpose, based on similar technology. The common specifications for each of the groups of products listed in Annex XVI shall address, at least, application of risk management as set out in Annex I for the group of products in question and, where necessary, clinical evaluation regarding safety.
The necessary common specifications shall be adopted by 26 May 2020. They shall apply as from six months after the date of their entry into force or from 26 May 2020, whichever is the latest.
Notwithstanding Article 122, Member States' measures regarding the qualification of the products covered by Annex XVI as medical devices pursuant to Directive 93/42/EEC shall remain valid until the date of application, as referred to in the first subparagraph, of the relevant common specifications for that group of products.
This Regulation also applies to clinical investigations conducted in the Union concerning the products referred to in the first subparagraph.
本條例還應自第9條通過的通用規範的適用之日起，考慮到現有技術水平，適用於附件XVI中所列的無預定醫療用途的產品組；以及特別是基於類似技術的，具有醫療用途的類似設備的現有統一標準。附件XVI中列出的每種產品組的通用規範應至少針對附件I所述產品組解決風險管理的應用問題，並在必要時進行有關安全性的臨床評估。
必要的通用規範應在2020年5月26日之前採用。它們應自其生效之日起六個月或2020年5月26日起適用，以最新的為準。
儘管有第122條的規定，成員國根據附件9VI2 / EEC指令對附件XVI涵蓋的產品進行醫療器械資格認證的措施應一直有效，直到相關共同點的第一款所指的應用日期為止。該組產品的規格。
3. Devices with both a medical and a non-medical intended purpose shall fulfil cumulatively the requirements applicable to devices with an intended medical purpose and those applicable to devices without an intended medical purpose.具有醫療用途和非醫療用途的設備應累積滿足適用於有醫療目的的設備和適用於無醫療目的的設備的要求。
4. For the purposes of this Regulation, medical devices, accessories for medical devices, and products listed in Annex XVI to which this Regulation applies pursuant to paragraph 2 shall hereinafter be referred to as ‘devices’.在本法規中，本法規根據第2款適用於附件XVI的醫療器械，醫療器械配件和產品在下文中稱為“器械”。
5. Where justified on account of the similarity between a device with an intended medical purpose placed on the market and a product without an intended medical purpose in respect of their characteristics and risks, the Commission is empowered to adopt delegated acts in accordance with Article 115 to amend the list in Annex XVI, by adding new groups of products, in order to protect the health and safety of users or other persons or other aspects of public health.如果由於具有預期醫療目的的設備投放市場而具有非預期醫療目的的產品在特性和風險上具有相似性，則有理由根據歐盟法典第115條授權委員會採取委託行動通過增加新的產品類別來修改附件XVI中的清單，以保護使用者或其他人的健康與安全或公共衛生的其他方面。
6. This Regulation does not apply to:
| (a) | in vitro diagnostic medical devices covered by Regulation (EU) 2017/746;（EU）2017/746法規涵蓋的體外診斷醫療器械; |
(b) |
medicinal products as defined in point 2 of Article 1 of Directive 2001/83/EC. In deciding whether a product falls under Directive 2001/83/EC or under this Regulation, particular account shall be taken of the principal mode of action of the product;指令2001/83 / EC第1條第2點所定義的藥品。在確定產品屬於指令2001/83 / EC還是本法規的過程中，應特別考慮到該產品的主要作用方式； |
(c) |
advanced therapy medicinal products covered by Regulation (EC) No 1394/2007;第1394/2007號法規（EC）涵蓋的先進治療藥物； |
(d) |
human blood, blood products, plasma or blood cells of human origin or devices which incorporate, when placed on the market or put into service, such blood products, plasma or cells, except for devices referred to in paragraph 8 of this Article;人體血液，血液製品，血漿或人類血細胞或在市場上投入使用或投入使用時包含此類血液製品，血漿或細胞的器械，但本條第8款所指器械除外； |
(e) |
cosmetic products covered by Regulation (EC) No 1223/2009;EC）1223/2009號法規涵蓋的化妝品； |
(f) |
transplants, tissues or cells of animal origin, or their derivatives, or products containing or consisting of them; however this Regulation does apply to devices manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or are rendered non-viable;動物來源的移植物，組織或細胞，或其衍生物，或含有它們或由其組成的產品；但是，本法規確實適用於利用動物來源的組織或細胞或它們的衍生物製造的，不能存活或變得不能存活的設備； |
(g) |
transplants, tissues or cells of human origin, or their derivatives, covered by Directive 2004/23/EC, or products containing or consisting of them; however this Regulation does apply to devices manufactured utilising derivatives of tissues or cells of human origin which are non-viable or are rendered non-viable;2004/23 / EC指令涵蓋的人類起源的移植物，組織或細胞，或其衍生物，或包含或由其組成的產品；但是，本法規的確適用於使用無生命或變得無生命的人類組織或細胞衍生物製造的器械； |
(h) |
products, other than those referred to in points (d), (f) and (g), that contain or consist of viable biological material or viable organisms, including living micro-organisms, bacteria, fungi or viruses in order to achieve or support the intended purpose of the product;除（d），（f）和（g）點所提及的產品外，為了實現或支持而含有或由活生物材料或活生物組成的產品，包括活微生物，細菌，真菌或病毒產品的預期用途； |
(i) |
food covered by Regulation (EC) No 178/2002.（EC）第178/2002號法規涵蓋的食品。 |
7. Any device which, when placed on the market or put into service, incorporates as an integral part an in vitro diagnostic medical device as defined in point 2 of Article 2 of Regulation (EU) 2017/746, shall be governed by this Regulation. The requirements of Regulation (EU) 2017/746 shall apply to the in vitro diagnostic medical device part of the device.任何在市場上投入使用或投入使用的，結合了第（EU）2017/746號條例第2條第2點第2點所定義的體外診斷醫療裝置為一體的設備，均應受本規定管轄。 。法規（EU）2017/746的要求應適用於器械的體外診斷醫療器械部件。
8. Any device which, when placed on the market or put into service, incorporates, as an integral part, a substance which, if used separately, would be considered to be a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma as defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the device, shall be assessed and authorised in accordance with this Regulation.
However, if the action of that substance is principal and not ancillary to that of the device, the integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004 of the European Parliament and of the Council (34), as applicable. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part are concerned.任何在市場上投入使用或投入使用的設備，作為一種組成部分，都包含某種物質，如果單獨使用，則該物質將被視為《 2001年指令》第1條第2點所定義的藥品。 / 83 / EC，包括該指令第1條第10點所定義的源自人體血液或人體血漿的藥品，並且具有與該設備的行為相輔相成的作用，應根據本法規進行評估和授權。
但是，如果該物質的行為是主要的，而不是該設備的行為，則該集成產品應受歐洲議會和理事會的指令2001/83 / EC或法規（EC）No 726/2004的管轄（ 34）（如適用）。在這種情況下，就設備部件的安全性和性能而言，應適用本法規附錄I中規定的相關一般安全性和性能要求。
9. Any device which is intended to administer a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC shall be governed by this Regulation, without prejudice to the provisions of that Directive and of Regulation (EC) No 726/2004 with regard to the medicinal product.
However, if the device intended to administer a medicinal product and the medicinal product are placed on the market in such a way that they form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part of the single integral product are concerned.
任何旨在管理第2001/83 / EC號指令第1條第2點所定義的藥品的設備，均應受本法規的管轄，但不得損害該指令和（EC）726號法規的規定/ 2004關於藥品。
10. Any device which, when placed on the market or put into service, incorporates, as an integral part, non-viable tissues or cells of human origin or their derivatives that have an action ancillary to that of the device shall be assessed and authorised in accordance with this Regulation. In that case, the provisions for donation, procurement and testing laid down in Directive 2004/23/EC shall apply.
However, if the action of those tissues or cells or their derivatives is principal and not ancillary to that of the device and the product is not governed by Regulation (EC) No 1394/2007, the product shall be governed by Directive 2004/23/EC. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part are concerned.任何在市場上投入使用或投入使用的器械，如果其整合了具有人類活動能力的非活組織或細胞或其衍生物，並且其功能是該器械的輔助功能，則應進行評估和授權。按照本法規。在這種情況下，應適用第2004/23 / EC號指令中規定的捐贈，採購和測試規定。
但是，如果這些組織或細胞或其衍生物的作用是主要的，而不是該設備的輔助作用，並且產品不受法規（EC）1394/2007的管轄，則該產品應受2004/23 /指令的管轄。 EC。在這種情況下，就設備部件的安全性和性能而言，應適用本法規附錄I中規定的相關一般安全性和性能要求。 11. This Regulation is specific Union legislation within the meaning of Article 2(3) of Directive 2014/30/EU.本法規是歐盟2014/30 / EU指令第2（3）條所指的特定歐盟法規。
12. Devices that are also machinery within the meaning of point (a) of the second paragraph of Article 2 of Directive 2006/42/EC of the European Parliament and of the Council (35) shall, where a hazard relevant under that Directive exists, also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those requirements are more specific than the general safety and performance requirements set out in Chapter II of Annex I to this Regulation.在存在根據該指令相關的危害的情況下，也是歐洲議會和理事會指令2006/42 / EC第2條第2款（a）點所指的機械設備。 ，還應滿足該指令附錄I規定的基本健康與安全要求，在某種程度上，這些要求比本法規附錄I第II章規定的一般安全和性能要求更為具體。
13. This Regulation shall not affect the application of Directive 2013/59/Euratom.本法規不得影響指令2013/59 / Euratom的適用。
14. This Regulation shall not affect the right of a Member State to restrict the use of any specific type of device in relation to aspects not covered by this Regulation.本法規不得影響成員國就本法規未涵蓋的方面限制使用任何特定類型的設備的權利。
15. This Regulation shall not affect national law concerning the organisation, delivery or financing of health services and medical care, such as the requirement that certain devices may only be supplied on a medical prescription, the requirement that only certain health professionals or healthcare institutions may dispense or use certain devices or that their use be accompanied by specific professional counselling.本法規不得影響有關醫療服務和醫療服務的組織，提供或籌資的國家法律，例如要求只能以醫療處方提供某些設備的要求，只能允許某些保健專業人員或醫療機構的要求的法規分配或使用某些設備，或者在使用這些設備時要經過專門的專業諮詢。
16. Nothing in this Regulation shall restrict the freedom of the press or the freedom of expression in the media in so far as those freedoms are guaranteed in the Union and in the Member States, in particular under Article 11 of the Charter of Fundamental Rights of the European Union.本條例的任何規定均不得限制新聞自由或媒體的言論自由，只要這些自由在聯盟和成員國中得到保障，特別是根據《聯合國基本權利憲章》第11條得到保障。歐盟。