Person Responsible for Regulatory Compliance

Fulfil your EU MDR and IVDR obligations with confidence. ReguLogix provides external PRRC services for eligible smaller manufacturers and expert standby support for in-house PRRCs at larger organisations

Our PRRC Services

Supporting Compliance at Every Organisational Level

External PRRC for Smaller Manufacturers

For eligible organisations with fewer than 50 FTEs and less than €10M in global sales, ReguLogix can fulfil the full PRRC role externally — ensuring your EU MDR/IVDR obligations are met without the need for an in-house hire

Standby PRRC Support

For larger organisations with an in-house PRRC, ReguLogix provides expert advisory support — offering a second opinion on complex regulatory questions, enhancing decision-making, and demonstrating the required competence of your PRRC function

Regulatory Compliance Assurance

Ongoing oversight of EU MDR/IVDR conformity obligations — ensuring that your quality management system, technical documentation, and post-market activities all satisfy the PRRC's statutory responsibilities

EU MDR & IVDR Requirement

Understanding the PRRC Obligation

Under EU Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746, all manufacturers placing devices on the EU market must ensure they have at least one Person Responsible for Regulatory Compliance (PRRC) who possesses specific qualifications, experience, and responsibilities.

The PRRC must ensure that:

  • The conformity of devices is appropriately checked before release
  • Technical documentation and declarations of conformity are drawn up and kept up-to-date
  • Post-market surveillance obligations are fulfilled
  • Reporting obligations are met, including serious incidents and FSCA
  • Registration obligations are fulfilled for all devices
  • Any statement made in connection with the PRRC's role is accurate and non-misleading
Eligibility for external PRRC: To outsource the PRRC role, your device company must have fewer than 50 full-time employees and less than €10 million in global annual sales under Articles 15(6) of EU MDR/IVDR.
EU MDR & IVDR
Article 15 PRRC
obligations fulfilled
SME Focused Services
Tailored for smaller organisations
Expert Second Opinion
Standby support for in-house PRRCs
Post-Market Oversight
PMS, FSCA & reporting obligations

Get in Touch with Us

Discover the flexible ways you can engage with our services based on your company's specific requirements. 
We offer the following options, which can be customised to align perfectly with your business needs:

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