Nov 27, 2018
What is the EU Person Responsible for Regulatory Compliance (PRRC) role in the EU MDR?
Compliance with European regulations has become progressively more complex, especially with the introduction of the EU Medical Device Regulation (2017/745) and In Vitro Diagnostic Regulation (2017/746). European regulators want to make sure companies always have a qualified regulatory expert at their disposal to ensure the company is meeting EU requirements.
Thus, the role of Person Responsible for Regulatory Compliance (PRRC) was created. Article 15 of the European MDR and IVDR mandate the appointment of this person and this June 2019 EU PRRC guidance document provides more clarity on the requirements. Many people have asked us what this new role entails and who needs to comply. We examined the nuts and bolts of this 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 EU PRRC is a separate role from your 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. As you know, your 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
According to the PRRC guidance document, the PRRC must have:
- Requisite expertise in the field of medical devices, and
- University degree, diploma, or some other formal qualifications, and
- At least one year of experience in European regulatory affairs or quality systems management related to medical devices,
OR…if no university degree, diploma, or other qualification, they must have four years of professional experience in European regulatory affairs or quality systems management related to medical devices
The key word to note above is experience in European regulatory affairs and QMS requirements. Having 10 years of FDA experience but little or no European RA/QA experience won’t cut it.
Can the PRRC be outsourced? Can it be more than one person?
If you do not meet the micro/small company definition below, 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 but they must reside in Europe according to Paragraph 6 of the PRRC guidance.
If you do not have an EU employee on staff in this role, you must have a “permanent and continuous” contract (essentially someone on retainer) in place with someone who meets the requirements set forth above and who resides in the EU. That means, for example, if you are a US company and work primarily with a US-based consultant who helps you with regulatory compliance, that person cannot be your PRRC regardless of how much European regulatory experience they possess. The same is true if you have an experienced regulatory team in the US but no regulatory team in Europe.
You are not limited to one PRRC. Larger entities may have more than one person in this role with defined responsibilities segmented by product lines or 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. Remember each PRRC must be located in the EU, and each legal manufacturer under the parent company must have its own PRRC!
Small medical device companies don’t need a PRRC on staff if…
All companies need a PRRC. There is no exemption for small manufacturers or those only marketing low-risk devices in Europe. However, the EU recognizes that many small manufacturers cannot afford (and do not need) someone on staff in that role so they outsource their regulatory compliance to an outside expert.
Article 15 offers some relief to “micro and small” enterprises. Basically, you are exempt from having a PRRC on staff as an employee 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)
Remember, if you outsource the PRRC, that person 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. Your outsourced PRRC must be permanently available to you and integrated into the organization in a manner that allows you to fulfill the requirements of the EU MDR/IVDR.
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 confirm that they have someone on staff who meets the PRRC qualifications noted above.
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 an excerpt that so 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.
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!