PRRC的角色（负责法规遵从的人）

Who can be PRRC and what are their Roles and responsibilities?

The PRRC can be any person who has therequisite expertise in the field of medical devicesand requisite expertise shall be demonstrated by the below qualifications. To perform a role of PRRC one should fulfil following criteria：

• 该人应持有the Diploma or University Degree在法律，医学，药房，工程和其他相关纪律被成员国认可，并拥有至少一年医疗器械质量管理体验。 

要么

• 与医疗设备有关的监管事务或质量管理系统的四年专业经验。

如果您是制造商定制设备without prejudice to national provisions regarding professional qualifications, manufacturer may demonstrate the requisite expertise by having at least two years of professional experience within a relevant field of manufacturing.

If a manufacturer does not have a person who can meet the above prerequisites, then they can

• Hire a new employee who will fulfil this role.

• 聘请顾问一段时间，同时培训现有的员工。

The small manufacturers fewer employees (less than 50) can outsource the experts as PRRC with fulfilling all criteria, which means the micro/small enterprises who don’t have a person within their organization then the responsibility can be taken care by a consultant who is “permanently “or continuously” available for the site. Manufacturers can have more than one PRRC if they meet the above stated prerequisites, they need to define their roles and responsibilities.

What are the Roles of PRRC and Responsibilities of PRRC? 

• 根据设备被释放之前，根据该设备的质量管理系统适当地检查设备的符合性。

• 保持技术文件和EC符合性的符合性宣告。

• 导致产品的内部流程的合规性和有效性，

• Continuously monitor the Post market activities of medical devices,

• Reporting analysis of serious incidents, field safety corrective actions (FSCA), analysis of vigilance and trend reporting,

• 在任何严重的不利行动观察或发生的情况下，PRRC应通知授权代表，进口商，经销商和通知机构，

• 在任何更改或更新技术文件的情况下向当局通知，

• 国际标准和适用性遵守外部流程的适用性，包括潜在的采购和制造，

• 质量管理系统的维护和检查效果及其对设备制造商性能的影响，

• PRRC将确保促进整个组织的客户要求，

• Keep in touch with authorized representative, importer, distributor, notified body and conformity assessment,

• On EUDAMED the PRRC be act as local actor Administration (LAA) on behalf of the manufacturer,

• Manage all the EUDAMED related activities.

该授权代表需要PRRC吗？ 

Yes, your authorised representative must have a PRRC permanently and continuously at their disposal. The PRRC shall possess the appropriate qualification and experience as discussed in point no. 01.

任命PRRC.

你任命任命PRRC是类似的your management representative. You have to create and sign the agreement with the PRRC, with the following information 

• Purpose

• Scope

• 资格要求 

• Roles of PRRC and responsibilities of PRRC 

• 任何其他角色和责任

• Date and signature of the PRRC and Company Head. 

制造商需要确保在制造商的组织内不得遭受妥善履行他或她的职责，无论他们是否是本组织的雇员，都应遭受任何劣势。制造商应注意，只有合格的代表只能履行PRRC的作用。