Representation as Person Responsible for Regulatory Compliance (PRRC)

Representation as PRRC

Under EU MDR (2017/745) and IVDR (2017/746), manufacturers must appoint a Person Responsible for Regulatory Compliance (PRRC) to ensure compliance with regulatory obligations.

For companies without in-house regulatory expertise, failing to meet PRRC requirements can lead to non-conformities, certification delays, or market access restrictions. Our experienced consultants provide PRRC representation and advisory services, ensuring full compliance with EU regulations while minimising regulatory risks.

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Ensuring Compliance with PRRC Requirements

The PRRC role is mandatory for all medical device and IVD manufacturers under EU MDR/IVDR. The appointed individual must have proven regulatory expertise or experience and is responsible for overseeing quality management, technical documentation, post-market surveillance, and regulatory compliance.

Manufacturers face key challenges, such as:

  • Lack of internal PRRC expertise and meeting PRRC qualification criteria, particularly for small and medium-sized companies.
  • Understanding the PRRC’s responsibilities, including conformity assessment, vigilance reporting, and post-market surveillance (PMS).

 

Our consultants provide PRRC representation and support, ensuring that:

  • Your company meets EU MDR/IVDR PRRC requirements, avoiding regulatory penalties.
  • Technical documentation, QMS, and post-market activities comply with regulatory expectations.

Why use our support with representation as PRRC?

Appointing a qualified PRRC is essential for maintaining regulatory compliance and market access. With our expert PRRC services, your company can ensure full compliance with EU MDR/IVDR while maintaining a proactive approach to regulatory obligations. Our services include:

  • PRRC Representation for EU MDR/IVDR – Acting as your PRRC to ensure compliance with Article 15 of MDR/IVDR.
  • Release of Manufactured Product – The PRRC is responsible for release of product under the QMS
  • Maintenance of Technical Documentation – Ensuring technical documentation is up-to-date and in compliance with MDR/IVDR
  • Post-Market Surveillance (PMS) & Vigilance Compliance – Ensuring an effective PMS process is in place and that adverse event reporting is crried out in accordance with applicable regulations
Your contact person
Portrait of Nelly Fransen Arex Advisor

Nelly Fransén

www.arexadvisor.com

Arex Advisor AB

  • Sveavägen 9,
  • 111 57 Stockholm
  • Sweden

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Staffan Thunell

Founding partner

BSc Economics and BA

Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from posit­ions as Founder, Chair­man, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.