What is PRRC?
PRRC is acronym of “Person Responsible for Regulatory Compliance”. EUMDR introduces new requirements for the medical devices manufacturers, which explains the roles of PRRC. according to the new regulation of EUMDR, which came into force on 26 May 2021 the medical device manufacturer should have a PRRC to keep an eye on regulatory compliance. PRRC’s plays vital roles and responsibilities in setting up the plants for manufacturing medical devices.
The PRRC’s are the authorized person who should have some specific qualification and experience .EU has published new rules and regulations for medical devices manufacturers that, these companies or organizations should have PRRC with them to look out the matter of regulations and policies PRRC is responsible for regulatory compliance Article 15(1) of MDR and IVDR has outlined some specific prerequisite for PRRC. The medical device manufacturer who wishes to sell/ supply their device in European Union they must have at least one Person Responsible for Regulatory Compliance (PRRC) at their site of disposal.AS a medical device consultant we know the importance of PRRC and CE marking certification and we help our clients in regulatory compliance process.
Who can be PRRC ?
The PRRC can be any person who has the requisite expertise in the field of medical devices and requisite expertise shall be demonstrated by the qualifications below.
- The person shall hold a Diploma or University Degree in Law, Medicine, Pharmacy, Engineering and other relevant disciplines recognized by the member state and have at least one year’s experience 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 of custom-made devices 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.
- Hire a consultant for some period of time and simultaneously train your existing employee.
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?
- 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.
Who needs to appoint PRRC?
- Manufacturers
- Importers, distributors and other people who are acting as manufacturers.
- Authorized representative.
Is that authorized representative requires PRRC?
Yes, your authorized 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
Appointment of the PRRC is similar as you appoint 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 organization 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.
What is the importance of identifying PRRC?
Identifying the PRRC for your organization is a most important requirement that applies to the European Union and is a core area of responsibility for a person or persons under the medical device regulation, or In vitro device regulation. The directive to appoint the PRRC also depends on the size of the organization. This is mandatory requirement for any CE Marking under the new EU MDR
The motivation for Identifying the PRRC positions is so that there is a qualified regulatory expert directly responsible for the manufacturing and the market surveillance and reporting systems to ensure the company is meeting the European Union requirements. Companies are not limited to one PRRC and the responsibilities can be allocated to several people, as long as the requirements concerning qualification are met and the distribution of the respective areas of responsibility are documented. If the responsibilities are divided among more than one person, ensure that all responsibilities are covered.
The Regulations have a clear desire to add an additional level of scrutiny to the supervision and control of the manufacturing of medical devices, as well as relevant post-market surveillance and vigilance activities. Thus, Identifying the PRRC role is purposefully a sole position from the European Union Authorized Representative. The importance of Identifying the PRRC role by the MDR and IVDR goes beyond the role of a safety officer. MDCG 2019-7 provides the prescriptive guidance for PRRC in terms of qualification and responsibility. The manufacturer needs to identify the person who can cover this crucial role.
The right way of Identifying the PRRC is, if he\’s responsible for the technical documentation EU Declaration of Conformity (drawn up and kept up-to-date), post-market surveillance obligations and checking the conformity of devices before they are released (according to the quality management system implemented). Each legal manufacturer must have its own PRRC. The PRRC must be close to the manufacturer, which means that if the manufacturer is located in the EU, its PRRC must also be located in the EU.
At Operon Strategist we understand the complications of regulatory compliance and to make it easy for our clients we provide support and guidance. You can contact us anytime for the regulatory support and for detailed information.
