MedTech

The PRRC, or Person Responsible for Regulatory Compliance, is a new role introduced by the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). The PRRC is responsible for ensuring that a medical device manufacturer complies with all applicable EU regulations. This includes ensuring that the manufacturer’s quality management system (QMS) is compliant, that the devices are designed and manufactured safely, and that they are properly marketed and post-market surveillance.

The PRRC must have the following qualifications:

• A university degree or equivalent in a relevant field, such as, engineering, or law.
• At least 3 years of experience in regulatory affairs for medical devices.
• Knowledge of the EU MDR and IVDR.
• The ability to communicate effectively in English.
• The PRRC must be permanently and continuously available to the manufacturer. This means that they must be able to respond to inquiries from notified bodies, competent authorities, and other stakeholders at any time.

The PRRC’s responsibilities include:

• Overseeing the manufacturer’s QMS.
• Ensuring that the manufacturer’s devices comply with all applicable EU regulations.
• Preparing and submitting regulatory documentation, such as the Declaration of Conformity and the Technical Documentation.
• Responding to inquiries from notified bodies, competent authorities, and other stakeholders.
• Participating in audits and inspections.
• Reporting on regulatory compliance to the manufacturer’s management.

The PRRC can be an employee of the manufacturer or a third-party consultant. If the PRRC is a third-party consultant, the manufacturer must enter into a contract with the consultant that specifies the consultant’s responsibilities and liabilities.

The PRRC is an important new role under the EU MDR and IVDR. By ensuring that manufacturers comply with all applicable regulations, the PRRC helps to protect patients and ensure the safety of medical devices on the EU market.

If you are a medical device manufacturer, you need to ensure that you have a qualified PRRC in place. If you do not have the in-house resources to provide this function, you can outsource the PRRC service to a qualified consultancy firm.

At Asphalion we can help you with your PRRC needs. We have a team of experienced regulatory experts who can provide you with the support you need to comply with the EU MDR and IVDR. We can help you with all aspects of the PRRC process, from qualification and appointment to day-to-day support. We can also help you with other regulatory affairs matters, such as product registration, documentation preparation, and audit support.