这Person Responsible for Regulatory Complianceis one of the new requirement of the EU MDR European Medical Device Regulation and In-Vitro Diagnostic Regulation 2017/745 and 2017/746. As the European Union’s (EU) Medical Device Regulation (MDR) and In-Vitro Diagnostic Medical Device Regulation (IVDR) continue to evolve, one requirement is getting a lot of attention – the person responsible for regulatory compliance (PRRC.）。
This individual (or individuals) is one of the newly introduced requirements of the MDR/IVDR and their presence is to ensure that companies have a qualified regulatory expert at their disposal. If a company consists of more than one legal manufacturer, each legal manufacturer must appoint its ownPRRC.。Both the MDR and the IVDR require a“person responsible for regulatory compliance“（PRRC）。
- 作为CE Mark顾问对于医疗设备，我们将帮助您提供具有所有产品详细信息的定义技术文件的过程。
- 我们将帮助您满足欧洲提交标准，该标准说明所提供的产品符合欧洲安全的确切要求。
这Person Responsible for Regulatory Compliancedoes not replace the European Authorized Representative (EC Rep). However, the two roles are symbiotic. As you know, your EC Rep must be located in Europe and meet requisite qualifications that are well defined in the MDD/IVDD and MDR/IVDR. The EC Rep’s name and address must appear on labeling. However, the EC Rep does not have nearly as many responsibilities as those assigned to thePerson Responsible for Regulatory Compliance.
Who can be a PRRC?
MDR和IVDR呼吁拥有医疗器械领域所必需的专业知识，该人被定义为所证明的资格：
完成大学学位或一项学习课程的文凭，证书或其他正式资格证据，该课程被有关会员国，法律，医学，药房，工程或其他相关科学学科，以及至少一年的监管事务的专业经验或与医疗设备相关的质量管理系统或者，4年的监管事务或与医疗设备相关的质量管理系统专业经验。
虽然通过文凭或证书轻易记录正式资格，但也必须展示医疗器械监管事务或质量管理系统的专业经验（参考欧盟中获得的经验）。基于专业经验的资格必须与工作合同，组织结构图，培训证据或内部记录等文档进行证实，如文件发布。
PRRC资格
欧盟MDR以及新IVDR定义再保险quirements of thePerson Responsible for Regulatory Compliance。MDR第15条概述了以下要求：
- 正式资格，法律，医学，药房，工程或其他相关科学学科的文凭，证书或其他证据，
- 至少有一年的监管事务或与医疗器械有关的质量管理系统的专业经验;要么
- Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
的作用person responsible for regulatory compliance (PRRC)
的作用Person Responsible for Regulatory Complianceis defined in Article 15 of the EU MDR (2017/745). MDR requires medical device manufacturers to appoint a designated employee with regulatory expertise to ensure compliance with the EU MDR. The PRRC is responsible for ensuring that:
- 这conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released
- 技术文件和欧盟符合委员会的宣布被绘制并保持最新
- 这post-market surveillance obligations are complied with in accordance with the requirement of the MDR
- 履行报告义务
Does every medical device manufacturer require a PRRC?
这mandate to appoint aPerson Responsible for Regulatory Compliancedepends on the size of your organization. The MDR provides an exception for small manufacturers. Medical device manufacturers with fewer than 50 full-time employees (globally)and在全球销售收入（不仅仅是欧盟）的1000万欧元下不需要有一个Person Responsible for Regulatory Compliancewithin the company. However, these small manufacturers can outsource the role but are still required to “have such person permanently and continuously at their disposal.” It is also important to note that thePerson Responsible for Regulatory Compliance要求甚至包含低风险设备。
What are the responsibilities ofPerson Responsible for Regulatory Compliance角色还
- Checking that the device conforms to the manufacturers QMS prior to release
- 验证技术文件和欧盟符合委员会的妥善实施和维护
- Managing and ensuring that post-market surveillance obligations are complied with; including post market surveillance plan, post-market report and periodic safety update report as applicable
- Ensuring that the reporting obligations are fulfilled for serious incidents, field safety corrective actions and trend reporting
- 第4.1条第4.1条所提到的附件XV第4.1章发行于调查装置的情况下发布。
Who should employ a Person Responsible for Regulatory Compliance?
微型和小型公司应该永久和持续进入此类人的服务。该服务可以外包。较大的公司应该在其组织中拥有这样的人。
负责监管合规性的人的要求取决于经济活动者的类型和规模和作用。与负责监管合规的人员，MDR和IVDR介绍了责任和重要性远远超出了安全官的作用。