PRRC - Regulatory Affairs - QbD Group (2)

Person Responsible for Regulatory Compliance (PRRC)

Are you looking for a person responsible for regulatory compliance (PRRC) for your medical devices and/or IVDs?

The QbD Group provides PRRC services to manufacturers of both medical devices (MD) and in vitro diagnostics (IVDs) with fewer than 50 employees who do not have an internally qualified RAQS (Regulatory Affairs and Quality Systems) position.

For IVD manufacturers located outside the EEA, we also provide support through the EU Authorized Representative’s PRRC service.

What is a PRRC?

KEY TO PLACING YOUR DEVICE ON THE EUROPEAN MARKET

To sell products in the EU market, manufacturers of medical devices and/or IVDs must officially designate a PRRC (Person Responsible for Regulatory Compliance). This role is a mandatory requirement under the EU MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation).

Without an officially designated PRRC, companies cannot market their products in the EU.

Small and micro companies (fewer than 50 employees and annual turnover and/or balance sheet <€10M) often struggle to hire qualified RAQS resources due to limited availability and high costs. Outsourcing this service to our QbD experts provides an efficient solution.

Responsibilities of a PRRC

The PRRC must:

Ensure compliance with EU regulations.
Review the Quality Management System (QMS) and technical documentation before products reach the market.
Be notified of audits, QMS/product changes, complaints, recalls, or field safety actions.
Be permanently and continuously available to the company.

Additional Responsibility for IVD Manufacturers

For IVD manufacturers, especially those outside the EEA, the PRRC must also ensure that the EU Authorized Representative fulfills its obligations as specified in Article 11(3) of the regulations. This includes overseeing the agreed tasks within the mandate between the manufacturer and the Authorized Representative.

How can we support you?

We provide tailored PRRC services based on your needs:

For medical devices:

Act as your PRRC for small or micro enterprises.
Consult on regulatory requirements for PRRC designation and tasks.
Assist in writing or reviewing procedures related to PRRC responsibilities.

For IVDs:

Act as your PRRC for small or micro enterprises.
Act as the PRRC for the EU Authorized Representative, ensuring their obligations under the regulatory mandate are fulfilled.
Consult on regulatory requirements for PRRC designation and tasks.
Assist in writing or reviewing procedures related to PRRC responsibilities.

PRRC - Regulatory Affairs - QbD Group (1)

Why partner with QbD Group?

To ensure easy access to the European market, it is important to choose an experienced person responsible for regulatory compliance (with at least four years of professional experience in regulatory affairs or in quality management systems related to medical devices) who can guide you through the process.

QbD Group’s experts can act as your outsourced PRRC, helping your company comply with EU regulations for medical device and IVD manufacturers.

With over 20 years of industry experience, we can guarantee you the benefit of an outsourced center of excellence for all quality & regulatory matters, in a cost-effective manner.

Finally, the process for designating a QbD Group PRRC is well structured and is based on the intensive involvement of the QbD Group designated person for the PRRC service in the company’s processes.