MDR法规原文中英对照

Article 3  Amendment of certain definitions

The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to amend the definition of nanomaterial set out in point (18) and the related definitions in points (19), (20) and (21) of Article 2 in the light of technical and scientific progress and taking into account definitions agreed at Union and international level.

Article 4  Regulatory  status  of products

1. Without prejudice to Article 2(2) of Directive 2001/83/EC, upon a duly substantiated request of a Member State, the Commission shall,  after consulting the Medical Device Coordination Group established under Article 103 of this Regulation (‘MDCG’), by means of implemen­ ting acts, determine whether or not a specific product, or category or group of products, falls within the definitions of ‘medical device’ or ‘accessory for a medical device’. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3) of this Regulation.

2. The Commission may also, on its own initiative, after consulting  the MDCG, decide, by means of implementing acts, on the issues  referred to in paragraph 1 of this Article.  Those  implementing  acts  shall be adopted in accordance  with  the  examination  procedure  referred to in Article 114(3).

3. The Commission shall ensure that Member  States share expertise  in the fields of medical devices, in vitro diagnostic medical devices, medicinal products, human tissues and cells, cosmetics, biocides, food and, if necessary, other products, in order to determine the appropriate regulatory status of a product, or category or group of products.

4. When deliberating on the possible regulatory status as a device of products involving medicinal products, human tissues and cells, biocides or food products, the Commission shall ensure an appropriate level of consultation of the European Medicines Agency (EMA), the European Chemicals  Agency  (ECHA)  and  the  European  Food   Safety Authority (EFSA), as relevant.

委员会有权根据第115条采取授权行动，以修改第（18）点中规定的纳米材料的定义以及第2条第（19），（20）和（21）点中的相关定义。结合技术和科学进步，并考虑到联盟和国际层面商定的定义。

1，在不影响第2001/83 / EC号指令第2（2）条的情况下，应成员国的充分证实的要求，委员会应在根据本法规第103条设立的医疗器械协调小组（``MDCG'' ），通过实施行动，确定特定产品或产品类别或产品组是否属于“医疗设备”或“医疗设备附件”的定义。实施细则应当依照本条例第114条第3款规定的审查程序采取。

2，委员会也可以在征询《千年发展目标》之后，主动采取行动，对本条第一款所述问题作出决定。那些实施行为应按照第114条第3款规定的审查程序通过。

3.委员会应确保成员国分享医疗器械，体外诊断医疗器械，药品，人体组织和细胞，化妆品，杀菌剂，食品以及必要时其他产品领域的专业知识，以便确定产品或产品类别或产品组的适当监管状态。

4，在审议作为涉及药品，人体组织和细胞，杀生物剂或食品的产品的装置可能的监管地位时，委员会应确保与欧洲药品管理局（EMA），欧洲化学品管理局进行适当程度的磋商（ECHA）和欧洲食品安全局（EFSA）相关。