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透明（PRRC）。
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Contact Us WhatsApp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要求一个拥有医疗设备领域必要专业知识的人，该专业知识被定义为任何两者都证明的资格：
授予大学学位或研究课程的文凭，证书或其他正式资格证据一年的监管事务或与医疗设备有关的质量管理系统的专业经验或者，在监管事务或与医疗设备有关的质量管理系统方面有四年的专业经验。
虽然可以通过文凭或证书轻松记录正式资格，但也必须证明医疗设备监管事务或质量管理系统的专业经验（指欧盟获得的经验）。基于专业经验的资格必须通过文件，例如工作合同，组织图表，培训证据或内部记录（例如文件发布）来证实。
PRRC资格
这EU MDR, as well as the new IVDR, define the requirements of thePerson Responsible for Regulatory Compliance。MDR的第15条概述了这些要求：
- 法律，医学，药房，工程或其他相关科学纪律的文凭，证书或其他正式资格证据
- 至少有一年的专业经验在监管事务或与医疗设备有关的质量管理系统中；或者
- Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
角色person responsible for regulatory compliance (PRRC)
角色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
- 制定了技术文档和欧盟的合格声明，并保持最新状态
- 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全球销售收入（不仅仅是欧盟）不超过1000万欧元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需求甚至包括低风险设备。
What are the responsibilities ofPerson Responsible for Regulatory Compliance角色？
- Checking that the device conforms to the manufacturers QMS prior to release
- 验证技术文档和欧盟的合格声明得到了适当的实施和维护
- 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
- 在调查设备的情况下，发出了附件XV第二章第4.1节中提到的声明。
Who should employ a Person Responsible for Regulatory Compliance?
微型公司和小型公司应具有永久且连续地访问此人的服务。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行为者的类型和规模和角色。由于负责监管合规性的人，MDR和IVDR引入了一个角色，其责任和重要性远远超出了安全官员的责任。