What Is the New EU PRRC (Person Responsible for Regulatory Compliance) Role?
Compliance with European regulations has become progressively more complex, especially with the recent publication of the EU Medical Device Regulation (2017/745) and In Vitro Diagnostic Regulation (2017/746). With the new regulations, European regulators want to make sure companies always have a qualified regulatory expert on staff or at their disposal to ensure the company is meeting EU requirements.
You may have heard about a new role called the Person Responsible for Regulatory Compliance as defined in the new EU MDR and IVDR. Article 15 of the European MDR and IVDR mandate the appointment of this person. Many people have asked us what this new role entails and who needs to comply. We examined the nuts and bolts of this new requirement and here’s what you need to know.
Tip: We have taken the full text of the EU MDR and added a linked Table of Contents. You can download it here and you’ll find Article 15 on page 29.
The PRRC is different than an EU Authorized Representative
Let’s clarify one thing straight away. The PRRC does not replace the European Authorized Representative (EC Rep). However, the two roles are symbiotic. The 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 the PRRC in Section 3, Chapter 1, Article 15 of the EU MDR. Here’s an abbreviated list of PRRC responsibilities:
- Check conformity of devices with QMS procedures before they are released
- Make sure all Technical Documentation and Declarations of Conformity are up to date
- Ensure all postmarket surveillance and reporting obligations are met
Qualifications of the Person Responsible for Regulatory Compliance
The EU MDR and IVDR stipulate that the PRRC must have:
- Requisite expertise in the field of medical devices, and
- A university degree, diploma, or some other formal qualifications, and
- At least one year of experience in regulatory affairs or quality systems management related to medical devices, or
- If no university degree, diploma, or other qualification, must have four years of professional experience in regulatory affairs or quality systems management related to medical devices
Medical device companies don’t need a PRRC on staff if…
So what happens if you are a smaller company and you outsource all of your regulatory compliance? Article 15 offers some relief to “micro and small” enterprises exempt from having a PRRC on staff. Basically, you are exempt from having a PRRC on staff if, at the close of your most recent accounting period, you had:
- Fewer than 50 FTE global employees, and
- Under €10 million in sales/turnover (global revenue, not just EU)
You’ll notice that there is no exemption for manufacturers that are only marketing low-risk devices in Europe. All companies need a PRRC. European Commission Recommendation 2003/361/EC spells out the definition of “micro and small” companies as mentioned above. We saved you the drudgery of reading the European Commission’s 3,700-word definition of “small companies,” but we wanted to share a short excerpt that beautifully captures its poetic essence:
As regards the ceiling for the balance sheet total, in the absence of any new element, it is justified to maintain the approach whereby the turnover ceilings are subjected to a coefficient based on the statistical ratio between the two variables. The statistical trend requires a greater increase to be made to the turnover ceiling. Since the trend differs according to the size-category of the enterprise, it is also appropriate to adjust the coefficient in order to reflect the economic trend as closely as possible and not to penalise microenterprises and small enterprises as opposed to medium-sized enterprises.
Can the PRRC be outsourced? Can it be more than one person?
Yes and no. If you do not meet the micro/small company definition above, you must have a qualified employee act as your Person Responsible for Regulatory Compliance. Fortunately, the EU MDR allows you to designate “at least” one person within your company to be responsible for regulatory compliance. This allows companies to identify more than one person who may be responsible for regulatory compliance, such as by product line or by compliance needs (e.g., Technical Documentation, postmarket surveillance, or new product development). You simply need to document who these people are, explain how they are qualified and competent, and define their respective areas of responsibility.
If you do meet the definition of a micro/small company, you can outsource this role as long as the person to whom you’re outsourcing the role is qualified and “permanently and continuously” at your disposal. That could be a problem for some smaller companies depending on where their outsourced PRRC is located, such as a consultant who has to travel to the facility. In practice, if you are located outside the EU, your Authorized Representative (EC Rep) could fulfill this role for you, but again this entity would be located in Europe. It would be hard to justify that your PRRC is permanently and continuously at your disposal if your facility is located in Chicago or Singapore. It should also be noted that a PRRC is also required for the Authorized Representatives according to Article 15(6). If you have appointed a distributor as your Authorized Representative, you need to find out if they have someone on staff who meets the PRRC qualifications noted above.
If you qualify as a micro/small company and do not have someone with the regulatory expertise on staff, this means you may need to contract with an outside regulatory consultant to act as your PRRC. Remember, your outsourced PRRC needs to be qualified to handle European medical device regulatory compliance. After all, your PRRC will be considered a critical supplier and you should have appropriate agreements in place. As part of your supplier qualification process, this also includes contractors or consultants supporting your compliance efforts. If you outsource your PRRC, remember the stipulations above that this individual will be responsible for compliance with procedures, Technical Documentation, and postmarket surveillance obligations. This outsourced PRRC must be permanently available and integrated into the organization in a manner that allows you to fulfill the requirements of the EU MDR/IVDR.
When do we need to comply with European PRRC requirements?
Oriel STAT A MATRIX can help guide your transition to the EU MDR and IVDR in many ways, from EU MDR training and gap assessments to Clinical Evaluation Reports and internal audits. Let us know how we can help you!