Roles of PRRC (Person Responsible for Regulatory Compliance)

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:

• The person shall holdthe Diploma or University Degreein Law, Medicine, Pharmacy, Engineering and other relevant discipline recognised by the member state and have atleast a one-yearexperience in Quality Management of medical devices. 

Or

• Four years of professional experience in regulatory affairs or Quality Management systems relating to Medical Devices.

If you are the manufacturer ofcustom-made deviceswithout 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.

• Hire a consultant for some period of time and simultaneously train your existing employee.

小(小于制造商的员工数量也减少了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? 

• The 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.

• Keeping technical file and EC Declaration of conformity up to date.

• The compliance and effectiveness of internal process leading to product,

• 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,

• PRRC shall inform the authorized representative, importer, distributor and notified body in case of any serious adverse action observe or occur,

• Notification to authorities in the case of any change or update of technical documents,

• Applicability of international standard and applicability compliance of external processes, including potentially sourcing and manufacturing,

• Maintenance and check effectiveness of the quality management system and its effect on the performance of the devices manufacturer,

• The PRRC will ensure the promotion of customer requirements throughout the organization,

• 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.

Is that authorised representative requires PRRC? 

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.

Appointment of 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

• Qualification requirement 

• Roles of PRRC and responsibilities of PRRC 

• Any additional Roles and responsibilities

• Date and signature of the PRRC and Company Head. 

The manufacturer needs to ensure that PRRC shall suffer no disadvantage within the manufacturer’s organisation in relation to the proper fulfilment of his or her duties, regardless of whether or not they are employees of the organization. The manufacturer should note that only qualified representative can perform the role of PRRC.