欧盟临床研究的法律代表
legal representative是什么？
随着医疗器械出海以及全球化的趋势下，许多中国制造的高端医疗器械、高风险医疗器械开始进军欧洲，在MDR与IVDR法规逐渐由过渡期走向强制实施，医疗器械申报CE的合规性要求日趋严格。在临床评价模块，IIb和/或III类的高风险医疗器械，较多的中国制造商已经开始布局在欧洲开展临床研究，一来满足MDR的合规性要求，二来在产品获得CE认证后，无阻碍的进入特殊成员国市场（如德国）。
01
为什么需要欧盟法规代表legal representative？
根据MDR: Regulation (EU) 2017/745，CHAPTER VI，ARTICLE 62的要求，当申办方在欧盟开展临床研究，申办方如果不是欧盟公司，应当授权一名法规代表（也可以称为：合规代表、法定代理人、法律代表，legal representative），法规代表作为申办方在当地的通信接收人，且应当确保申办方在欧洲开展临床研究时符合MDR法规要求。
Where the sponsor of a clinical investigation is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its legal representative. Such legal representative shall be responsible for ensuring compliance with the sponsor's obligations pursuant to this Regulation, and shall be the addressee for all communications with the sponsor provided for in this Regulation. Any communication with that legal representative shall be deemed to be a communication with the sponsor.
02
欧盟法规代表legal representative的职责有哪些？
正如MDR 2017/745的Article 62所述，法规代表legal representative的主要职责是：
--确保临床研究符合MDR法规要求；
--作为在欧盟当地与监管沟通渠道，如发生安全性事件的沟通；
--当发现任何不符合法规的情形时通知申办；
--与申办进行合同约定，被授权的其他事项。
在MDCG 2021-06 Rev.1 中，对申办、法规代表的职责进行了描述：
In order to enable the legal representative to ensure compliance with the sponsor’s obligations under the MDR it is recommended that a contract between the parties obliges
- the sponsor to provide the legal representative with all required information and
- the legal representative to immediately notify the sponsor in case (s)he becomes aware of any noncompliance with the Regulation
03
欧盟法规代表legal representative如何开展工作？
同样在MDCG 2021-06 Rev.1 给出了如何开展工作的建议，比如对技术文件的符合性审查、临床研究文件的符合性审查、过程中可以开展临床研究的稽查、对临床研究的供应商的稽查等活动。
The legal representative is responsible for ensuring compliance with the sponsor’s obligations pursuant to the MDR. The MDR does not specify how a legal representative fulfils the legal obligations.
The legal representative may perform audits of the sponsor and its subcontractor(s), or check compliance by other means, according to prior agreement.
The legal representative would need permanent and integral availability and access to the technical documentation of the investigated device and clinical investigation documentation, in order to be able to ensure that this information has been drawn up and complies with the MDR.
For the legal representative it would be necessary to be aware of specific aspects of the clinical investigation, i.e. not only to check the availability of procedures on a general level., in order to be able to ensure that the clinical investigation is compliant with the MDR in practice.
It is necessary that the legal representative verifies, in parallel and/or in addition to the sponsor, all relevant documentation and keeps records of the verification activities performed. This verification is included in the legal representative’s responsibility for ensuring compliance with the sponsor's obligations pursuant to the MDR
鉴于欧洲的联盟属性，在欧洲开展临床研究，除了兼顾欧盟的MDR法规、MDCG指导文件之外，还需要兼顾成员国属地的法规。另外欧盟的电子化管理系统（UDAMED）还没有完全应用和公开，仍会存在较多的信息偏差与灰区。在欧洲开展医疗器械临床试验，选择一个丰富经验的法规代表legal representative能够规避较多的风险。
04
关于我们
Care-real科睿医疗为医疗器械制造商提供：
---中国 & 海外临床试验与临床评价；
---多国准入合规服务。
德国科睿医疗公司Crealkraft GmbH，Qikraft UG注册在德国杜塞尔多夫，具有唯一识别号SRN，公司团队具备丰富的法规经验、临床研究经验，对于“欧盟法规代表legal representative”服务，我们可以提供：
多维度审核CIP、IB、ICF的合规性，我们具备完善的临床研究的文件评估体系，审核重要文件的MDR符合性，以及审核成员国（尤其是德国、荷兰）的符合性；
临床研究过程的系统稽查，我们具有经验丰富的Auditor，在临床研究过程中
对临床研究进行稽查，确保临床研究过程的持续符合MDR、GCP、EC要求；
安全性事件的驻地处理；
作为申办方代表，与监管、伦理进行交流与沟通。
项目经验
喜讯|科睿医疗助力合作伙伴成功取得NMPA第三类医疗器械注册证！
喜讯！科睿医疗合作中心首个临床试验项目--动态心电记录仪顺利获取注册证
喜讯|科睿医疗CareMed 助力 觅光AMIRO 连获2证！
联系我们
|
|
|
|
END
