中英文对照新版欧洲医疗器械法规资料MDR2017_745 Part 1
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Devices with a non-medical intended purpose非医疗目的的器械
• Devices with both a medical and a nonmedical 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.具有医疗和非医 疗预期目的器械应逐渐的满足适用于具有 预期医疗目的器械要求和适用于无预期医 疗目的器械的那些要求。
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• (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;动物源 的移植器官、组织或细胞或其衍生产品，或含有或由其组成的产品； 但本法规适用于使用非活性或活性动物来源的组织或细胞或其衍生产 品制造而成的器械。 • (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 nonviable or are rendered non-viable; 第2004/23/EC号指令所涵盖的人源 移植器官、组织或细胞或其衍生产品，或含有或由其组成的产品；但 器械适用于使用活性或非活性人源组织或细胞的衍生产品制造而成的 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;除了（d）、（f） 和（g）点中述及的那些含有或包括活性生物物质或活菌体（包括活 体微生物、细菌、真菌或病毒）以实现或支持产品预期用途的产品； • (i) food covered by Regulation (EC) No 178/2002.第178/2002号（EU） 法规所涵盖的食品。
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Entry into force and date of application 生效和应用日期
• 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 本法 规应在《欧盟官方公报》上公布后第20天生 效。 • 2. It shall apply from 26 May 2020. 自2020年5 月26日起适用。 • 3. By way of derogation from paragraph 2（略）
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三、Transitional provisions过渡期
1. From 26 May 2020, any publication of a notification in respect of a notified body in accordance with Directives 90/385/EEC and 93/42/EEC shall become void. 自2020年5月26日起，公告机构根据第90/385/EEC和 93/42/EEC号指令发布的任何通知将失效。 2. Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC prior to 25 May 2017 shall remain valid until the end of the period indicated on the certificate, except for certificates issued in accordance with Annex 4 to Directive 90/385/EEC or Annex IV to Directive 93/42/EEC which shall become void at the latest on 27 May 2022.在2017年5 月25日前根据第90/385/EEC和93/42/EEC号指令由公告机构发行的证书应 保持有效，直至证书所示的期限结束，除了根据第90/385/EEC号指令附 录4或第93/42/EEC号指令附录IV颁发的证书（其应于2022年5月7日自动 失效）。 Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 shall remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its issuance. They shall however become void at the latest on 27 May 2024.自2017年5月25日起根据第90/385/EEC和93/42/EEC号指令由公告 机构发行的证书应保持有效，直至证书所示的期限结束，从其交付日期 起有效期不得超过五年。但其应于2024年5月27日失效。
EU MDR 2017/745医疗器械法规
2017.09.15
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1
主要内容
1. 2. 3. 4. 法规立法和执行； 适用范围； 过渡期安排； 法规结构。
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一、REGULATION (EU) 2017/745法规
1. REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. 欧洲议会和理事会于2017年4月5日 签发的关于医疗器械第2017/745号法规，修订 了第2001/83/EC号指令，第178/2002号（EU） 法规和第1223/2009号（EU）法规，并废除了 理事会第90/385/EEC号和第93/42/EEC号指令
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This Regulation does not apply to
• (a) in vitro diagnostic medical devices covered by Regulation (EU) 2017/746;欧盟第2017/746号法规所涵盖的体外诊断医疗器械 • (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;如第2001/83/EC号指令第1条 第2点中所定义的医疗产品。在确定产品是否属于第2001/83/EC号指 令或本法规的范围时，应特别考虑产品的主要作用模式。 • (c) advanced therapy medicinal products covered by Regulation (EC) No 1394/2007;欧洲委员会第1394/2007号法规所涵盖的前沿疗法医药产品； • (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;人类血液或血液制品、人源的血浆或血细胞， 或者在投放市场或投入使用时，包含此类血液制品、血浆或细胞的器 械，但本条第8段所述的器械除外（8. 包含物）； • (e) cosmetic products covered by Regulation (EC) No 1223/2009;欧洲委 员会第1223/2009号法规所涵盖的美容产品；
Devices with a non-medical intended purpose非医疗目的的器械
• Devices with both a medical and a nonmedical 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.具有医疗和非医 疗预期目的器械应逐渐的满足适用于具有 预期医疗目的器械要求和适用于无预期医 疗目的器械的那些要求。
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• (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;动物源 的移植器官、组织或细胞或其衍生产品，或含有或由其组成的产品； 但本法规适用于使用非活性或活性动物来源的组织或细胞或其衍生产 品制造而成的器械。 • (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 nonviable or are rendered non-viable; 第2004/23/EC号指令所涵盖的人源 移植器官、组织或细胞或其衍生产品，或含有或由其组成的产品；但 器械适用于使用活性或非活性人源组织或细胞的衍生产品制造而成的 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;除了（d）、（f） 和（g）点中述及的那些含有或包括活性生物物质或活菌体（包括活 体微生物、细菌、真菌或病毒）以实现或支持产品预期用途的产品； • (i) food covered by Regulation (EC) No 178/2002.第178/2002号（EU） 法规所涵盖的食品。
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Entry into force and date of application 生效和应用日期
• 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 本法 规应在《欧盟官方公报》上公布后第20天生 效。 • 2. It shall apply from 26 May 2020. 自2020年5 月26日起适用。 • 3. By way of derogation from paragraph 2（略）
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三、Transitional provisions过渡期
1. From 26 May 2020, any publication of a notification in respect of a notified body in accordance with Directives 90/385/EEC and 93/42/EEC shall become void. 自2020年5月26日起，公告机构根据第90/385/EEC和 93/42/EEC号指令发布的任何通知将失效。 2. Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC prior to 25 May 2017 shall remain valid until the end of the period indicated on the certificate, except for certificates issued in accordance with Annex 4 to Directive 90/385/EEC or Annex IV to Directive 93/42/EEC which shall become void at the latest on 27 May 2022.在2017年5 月25日前根据第90/385/EEC和93/42/EEC号指令由公告机构发行的证书应 保持有效，直至证书所示的期限结束，除了根据第90/385/EEC号指令附 录4或第93/42/EEC号指令附录IV颁发的证书（其应于2022年5月7日自动 失效）。 Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 shall remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its issuance. They shall however become void at the latest on 27 May 2024.自2017年5月25日起根据第90/385/EEC和93/42/EEC号指令由公告 机构发行的证书应保持有效，直至证书所示的期限结束，从其交付日期 起有效期不得超过五年。但其应于2024年5月27日失效。
EU MDR 2017/745医疗器械法规
2017.09.15
Sterimd
1
主要内容
1. 2. 3. 4. 法规立法和执行； 适用范围； 过渡期安排； 法规结构。
Sterimd
2
一、REGULATION (EU) 2017/745法规
1. REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. 欧洲议会和理事会于2017年4月5日 签发的关于医疗器械第2017/745号法规，修订 了第2001/83/EC号指令，第178/2002号（EU） 法规和第1223/2009号（EU）法规，并废除了 理事会第90/385/EEC号和第93/42/EEC号指令
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This Regulation does not apply to
• (a) in vitro diagnostic medical devices covered by Regulation (EU) 2017/746;欧盟第2017/746号法规所涵盖的体外诊断医疗器械 • (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;如第2001/83/EC号指令第1条 第2点中所定义的医疗产品。在确定产品是否属于第2001/83/EC号指 令或本法规的范围时，应特别考虑产品的主要作用模式。 • (c) advanced therapy medicinal products covered by Regulation (EC) No 1394/2007;欧洲委员会第1394/2007号法规所涵盖的前沿疗法医药产品； • (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;人类血液或血液制品、人源的血浆或血细胞， 或者在投放市场或投入使用时，包含此类血液制品、血浆或细胞的器 械，但本条第8段所述的器械除外（8. 包含物）； • (e) cosmetic products covered by Regulation (EC) No 1223/2009;欧洲委 员会第1223/2009号法规所涵盖的美容产品；
