MDR法规原文中英对照

Article 8  Use  of  harmonised standards

1. Devices that are in conformity with the relevant harmonised stan­ dards, or the relevant parts of those standards, the references of which have been published in the Official Journal of  the  European  Union, shall be presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof.

The first subparagraph shall also apply to system or  process  requirements to be fulfilled in accordance with this Regulation by economic operators or sponsors, including those relating to quality management systems, risk management, post-market surveillance systems, clinical investigations, clinical evaluation or  post-market clinical follow-up (‘PMCF’).

References in this Regulation to harmonised standards shall be understood as meaning harmonised standards the references of which have been published in the Official Journal of the European Union.

2. References in this Regulation to harmonised standards shall also include the monographs of the European Pharmacopoeia adopted in accordance with the Convention on the Elaboration of a European Phar­ macopoeia, in particular on surgical sutures and on interaction between medicinal products and materials used in devices containing such medicinal products, provided  that  references  to  those  monographs have been published in the Official Journal of the European Union.

Article 9  Common specifications

1. Without prejudice to Article 1(2) and 17(5) and the deadline laid down in those provisions, where no harmonised standards  exist  or  where relevant harmonised standards are not  sufficient, or  where  there is a need to address public health concerns, the Commission,  after  having consulted the MDCG, may, by means of implementing acts,  adopt common specifications (CS) in respect of the general safety and performance requirements set out in Annex I, the technical documen­ tation set out in Annexes II and III, the clinical evaluation and post- market clinical follow-up set out in Annex XIV or the requirements regarding clinical investigation set out in Annex XV. Those implemen­ ting acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).

2. Devices that are in conformity with the CS referred  to  in  paragraph 1 shall be presumed to be in  conformity  with  the requirements of this Regulation covered by those CS or  the  relevant parts of those CS.

3. Manufacturers shall comply with the CS referred to in paragraph 1 unless they can duly justify that they have adopted solutions that ensure   a level of safety and performance that is at least equivalent thereto.

4. Notwithstanding paragraph 3, manufacturers of products listed in Annex XVI shall comply with the relevant CS for those products.

1，符合相关协调标准或标准相关部分的设备，其参考文献已在《欧盟官方公报》上发布，应假定符合本标准的要求这些标准或其部分涵盖的法规。

第一小节还应适用于经济经营者或发起人根据本法规要满足的系统或过程要求，包括与质量管理体系，风险管理，上市后监督系统，临床研究，临床评估或后期检验有关的要求。市场临床随访（'PMCF'）。

本法规中对协调标准的引用应理解为含义统一的标准，其引用已在《欧盟官方杂志》上发布。

2本法规中对协调标准的引用还应包括根据《阐述欧洲法医学》所制定的《欧洲药典》的专着，特别是关于外科缝合线以及药物产品与用于装有该药的器械的材料之间的相互作用的专着此类药物，前提是已在欧盟官方杂志上发布了对这些专着的引用。

1.在不损害第1条第2款和第17条第5款以及这些规定中规定的期限的前提下，不存在统一标准或相关统一标准不足或需要解决公共卫生问题时，委员会在征询了MDCG的意见后，可以通过实施法案，就附件I所规定的一般安全和性能要求，附件II和III所规定的技术文件采用通用规范（CS），附录XIV中规定的临床评估和上市后临床随访或附录XV中规定的有关临床研究的要求。这些实施行为应按照第114条第3款规定的审查程序采取。

2与第1款所述的CS相符的设备应被推定为与这些CS或CS的相关部分所涵盖的本法规的要求相符。

3.制造商应遵守第1款中提到的CS，除非他们有充分理由证明他们已采用确保安全和性能至少与之等效的解决方案。

4，尽管有第3款的规定，附件XVI中所列产品的制造商应遵守有关产品的相关CS。