TSQ & E New Service Addition: EU PRRC (Person Responsible for Regulatory Compliance) Role
With the new regulations i.e. EU MDR (2017/745), and In Vitro Diagnostic Regulation (2017/746), the requirements have become more stringent. The European regulators now want to ascertain that companies have a qualified and competent Regulatory Expert to manage the compliance of EU regulations. Therefore, a new role has been introduced known as the Person Responsible for Regulatory Compliance (PRRC). Article 15 of the European MDR and IVDR direct the appointment of such person. The PRRC guiding document released in June 2019 offers more transparency on the requirements. As numerous people have requested us what this new position involves and who must comply what. TS Q & E analyzed the nuts and bolts of this obligation.
The EU PRRC is a separate role from EU Authorized Representative (E.A.R.)
Let’s simplify one thing instantly. The PRRC does not substitute the European Authorized Representative (E.A.R.). But, the two roles are interdependent and require synergy. E.A.R must be available in Europe and comply with qualifications requisite that are well described in both the MDD/IVDD and MDR/IVDR. The E.A.R. name and address must reflect on labeling. But, the E.A.R. does not have approximately as many duties as those allocated to the PRRC in EU MDR Section 3, Chapter 1, and Article 15. Here’s a list of PRRC duties:
- Confirm conformity of devices with established QMS procedures beforehand when they are released in the supply chain.
- Ensure all Technical documents and Declarations of Conformity are updated.
- Make sure all post market surveillance and reporting responsibilities are fulfilled.
- Qualifications of the Person
Responsible for Regulatory Compliance. According to the guiding document on
PRRC , the PRRC must have:
- Necessary proficiency in the field of medical devices
- University diploma, degree, or some other formal qualifications
As a minimum of experience of an year in European regulatory affairs or quality systems management concerned with medical devices
- If no university diploma, degree, or other acceptable qualification available, then they must have experience of four years in professional capacity in the sphere of quality systems management or European regulatory affairs or concerned with medical devices
PRRC Service Outsourcing
There is a facility within MDR that permits micro and small enterprises to contract out the PRRC role and also they can have a suitably qualified person constantly at their service instead of having that individual within their organization. If one does not complies with definition of the micro and small company, then such companies must have a qualified employee act as their Person Responsible for Regulatory Compliance (PRRC).
Multiple or Single PRRC
Luckily, the EU MDR permits organizations to appoint “at least” one personnel within the organization to be in charge for regulatory compliance but they must be located in in Europe as stated by Paragraph 6 of the PRRC guidance. However, organizations where seem necessary for themselves can appoint multiple person, but each should qualify the eligibility criterion.
Some Myths about the new Requirement
There are some myths related to the role of the PRRC, lets discuss those:
Myth 1: PRRC should be Internally Managed
For small and medium companies; it is a myth to have it managed internally. There is no issue if you don’t have it internally, but you must have a “permanent and continuous” agreement (basically someone as a retainer). That person should comply the requirements described above and who lives in the EU. So for instance if you are an Asian company and work mainly with an Asian consultant who empowers and supports you with regulatory compliance, that individual cannot be the PRRC irrespective of how much European regulatory experience they have. The same is applicable if you have a qualified regulatory team in the Asia but no regulatory presence in Europe.
Myth 2: Only one PRRC for a Company
The companies are not just limited to only one PRRC. If the organization is a larger corporate body, they may have more than one individual in this role with distinct responsibilities bifurcated by product lines or the requirements of compliance (for instance post market surveillance, technical Documentation, or new product development). Organizations just need to articulate (in written) who these individuals are, describe how they are experienced and capable, and outline their individual roles and responsibility. Please note that each PRRC must be situated in the EU, and every legal manufacturer within the mother company must have their own PRRC. Group of companies cannot have one PRRC representing them all.
Myth 3: Small medical device businesses too need a PRRC on their Payroll
All organizations selling device in EU require a PRRC. There is no exception for small manufacturers or sellers of low-risk devices in Europe. But, the EU distinguishes that many small manufacturers cannot have enough money (and do not want) somebody on their own payroll in that role so they can subcontract their PRRC to an outside consultant like TS Q & E.
Article 15 provides definite assistance to “micro and small” enterprises. Essentially, small organizations are released from having a PRRC on their own payroll or as an employee of their own, but one will fall under this category, when you have:
- Smaller number than 50 FTE (Full-time) global employees
- Global Revenue needs to be under €10 million in sales/turnover
Myth 4: PRRC is not required for Authorized Representatives
It should also be remembered that a PRRC is also needed for the Authorized Representatives as per Article 15(6). If you have selected a distributor as company’s Authorized Representative, you must reconfirm that they have somebody on their payroll who comply the PRRC qualifications stated above.
Outsourcing your PRRC to an Expert like TS Q & E!
Remember, if you are small or medium enterprise and you are looking to contract out the PRRC, that person must be qualified enough to manage European medical device directives and regulatory compliance. Finally, your PRRC will be reflected as a serious supplier and you should have suitable contracts prepared. As part of your organization’s supplier qualification process in the Quality Management System, it also incorporates such contractors and experts facilitating organization’s compliance determinations. If your organization outsource the role PRRC, think of the conditions above that this person will be in charge for compliance with your Technical Documentation, QMS procedures, and post market surveillance obligations etc. The subcontracted PRRC must be available as per the needs and incorporated into the company in a way that allows your organization to comply the requirements of the EU MDR/IVDR.
TS Q & E comprehensively know about the role of the PRRC as per the new MDR and IVDR. TS Q & E has a pool of professionals who qualify with the given criterion, as the company is located in Europe with its core function for EU medical devices regulatory compliance, TS Q & E know how to handle this role and which of its collaborators and professionals are at best serving this responsibility. Please let us know your needs today.
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