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There are plenty of new requirements to be aware of in both the EU Medical Device Regulation (EU MDR) and the EU In Vitro Diagnostic Device Regulation (EU IVDR).
However, one requirement that has caught the attention of many medical device manufacturers is the mandate to create an entirely new role within the company. This role is the Person Responsible for Regulatory Compliance (PRRC), and it’s mandated by both EU MDR and EU IVDR.
In this article I’m going to answer some of the most pressing questions regarding the PRRC, their responsibilities, and what medical device companies should expect from the new requirements.
The role of PRRC is mandated in Article 15 of both the EU MDR and EU IVDR. These regulations require all manufacturers and Authorized Representatives to have a designated employee in their company who is responsible for regulatory compliance with the applicable MDR or IVDR requirements.
That’s a pretty broad definition, so here are some clarifying points to remember about the PRRC role:
You can have more than one PRRC. The regulations state that you must have “at least one” PRRC “permanently and continuously” at your disposal. So, if the responsibility feels too big for one person to handle, you can always split it up between multiple PRRCs.
The PRRC does not replace your European Authorized Representative (EC Rep). These are two separate roles, even though they may seem similar. Companies sometimes think they can kill two birds with one stone, but the PRRC has far more responsibility than the EC Rep.
The location of the PRRC depends on where your company is based. The Medical Device Coordination Group (MDCG) has released guidance on the PRRC requirements that states,
For manufacturers located outside the EU, it must be assumed that the PRRC should also be located outside the EU. On the other hand, for manufacturers located in the EU, it must be assumed that the PRRC should also be located in the EU.
MDR and IVDR outline five major responsibilities for a PRRC:
The PRRC will check the conformity of devices in accordance with the quality management system (QMS) the company uses before the device is released.
PRRC will ensure that technical documentation and the EU documentation of conformity are generated and up-to-date.
The PRRC will make sure the company complies with post-market surveillance obligations listed in Article 10(10) of MDR and Article 10(9) of IVDR.
Additionally, the PRRC will be responsible for ensuring that the company fulfills its reporting obligations, found in Articles 87-91 of MDR and Articles 82-86 of IVDR.
Finally, the PRRC will ensure that the statement from Section 4.1 of Chapter II of Annex XV of the MDR is issued if the company is building an investigational device. For the IVDR, this statement is located in Section 4.1 of Annex XIV.
Keep in mind, if you use more than one PRRC, the distribution of these responsibilities between them needs to be put down in writing.
Given the responsibilities of the PRRC role, the person who fills it needs to have some specific qualifications.
Article 15(1) of both MDR and IVDR call for the PRRC to have either:
A diploma (or other formal qualification from a university or equivalent course of study) in law, medicine, pharmacy, engineering, or another relevant scientific subject, AND at least one year of professional regulatory or quality management experience in the medical device or in vitro diagnostic device fields.
Four years of professional regulatory or quality management experience in the medical device field or in vitro diagnostic device fields.
Also note, the same MDCG guidance mentioned earlier in this article specifies that the professional experience in regulatory affairs or quality management “should be related to the EU requirements in the field.” So, for instance, an FDA regulatory expert would not be an appropriate PRRC unless they also had the appropriate EU-related experience.
The short answer is yes—but with a major caveat. To be eligible to outsource the PRRC role, your device company must have fewer than 50 full-time employees and less than €10 million in global sales.
If you meet those criteria, you are exempt from the rule requiring your PRRC to be an employee of your company and can outsource this role to a third party firm. The point to remember here is that the regulations still stipulate that this person must be “permanently and continuously” at your disposal.
PPRC must also hold the same qualifications from the previous section. And given the importance of their responsibilities, they’ll need to be integrated into your company in such a way that allows them to perform their duties as if they were an employee.
The regulatory environment for medical devices is always evolving, and staying in compliance is an ongoing challenge for medical device manufacturers.
At Greenlight Guru, we understand the nuance and intricacies of the regulatory space because we are medical device professionals. Our eQMS platform is the only one designed by medical device professionals for medical device professionals.
Our cloud-based platform allows your company to bring safer products to market faster, while reducing risk, lowering costs, and shifting your focus from merely complying with regulations to achieving True Quality.
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Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...