中英文对照欧洲医疗器械法规资料MDR2017_745 Part 1
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• 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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二、Scope范围
• 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. 本法规规定了有 关欧盟境内供人类使用的医疗器械极其附件的市 场投放、市场提供或投入使用方面的规则。本法 规也适用于在欧盟进行的有关该医疗器械及其附 件临床研究。
EU MDR 2017/745医疗器械法规
2017.09.15
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1
主要内容
1. 法规立法和执行； 2. 适用范围； 3. 过渡期安排； 4. 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
ຫໍສະໝຸດ Baidu
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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。
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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。
• (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）；
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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。
• 3. By way of derogation from paragraph 2（略）
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二、Scope范围
• 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. 本法规规定了有 关欧盟境内供人类使用的医疗器械极其附件的市 场投放、市场提供或投入使用方面的规则。本法 规也适用于在欧盟进行的有关该医疗器械及其附 件临床研究。
EU MDR 2017/745医疗器械法规
2017.09.15
Sterimd
1
主要内容
1. 法规立法和执行； 2. 适用范围； 3. 过渡期安排； 4. 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
ຫໍສະໝຸດ Baidu
Sterimd
6
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。
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5
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。
• (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）；
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3
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。