The Role of a PRRC (Person Responsible for Regulatory Compliance) in the EU MDR
The New EU MDR that will go into effect in May 2020 requires medical device companies to appoint a Person Responsible for Regulatory Compliance (PRRC). The PRRC does not replace the requirement for a European Authorized Representative (EC Rep). The role and requirement for an EC Rep was defined in the MDD and that requirement continues.
The role of the PRRC
The role of the PRRC is defined in Article 15 of the EU MDR (2017/745). MDR requires medical device manufacturers to appoint a designated employee with regulatory expertise to ensure compliance with the EU MDR. The PRRC is responsible for ensuring that:
- 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
- The technical documentation and the EU declaration of conformity are drawn up and kept up to date
- The post-market surveillance obligations are complied with in accordance with the requirement of the MDR
- Reporting obligations are fulfilled
The EU MDR, as well as the new IVDR, define the requirements of the PRRC. Article 15 of the MDR outlines these requirements as:
- A diploma, certificate or other evidence of formal qualification, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and
- At least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices; or
- Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Does every medical device manufacturer require a PRRC?
The mandate to appoint a PRRC depends on the size of your organization. The MDR provides an exception for small manufacturers. Medical device manufacturers with fewer than 50 full-time employees (globally) and under 10 million Euros in global sales revenue (not just EU) are not required to have a PRRC within the company. However, these small manufacturers can outsource the role but are still required to “have such person permanently and continuously at their disposal.” It is also important to note that the PRRC requirement even encompasses low-risk devices.
In larger organizations the regulations allow for more than one person to be designated for this role. This enables larger companies to have an entire team functioning as their PRRC.
As everyone involved in medical device regulatory compliance is aware, the demands of the new EU MDR are far more complex than the current MDD. As a Notified Body for the MDD and as an applicant to MDR approval, ECM’s recommendation for medical device manufacturers is to take a two-pronged regulatory strategy.
First, if you have products ready to market that have not yet received a CE marking under the MDD, it’s time to contact a Notified Body before time slots runs out. ECM has a limited number of openings and is still accepting applications for CE marking under MDD.
Second, if your product will not be ready prior to the transitional period, start the conversation with a Notified Body to better understand timelines, approvals and budgets of the new MDR requirements.