EU MDR Art. 15 / IVDR Art. 15

PRRC Services Person Responsible for Regulatory Compliance

Under the EU MDR (2017/745) and IVDR (2017/746), manufacturers and authorized representatives must designate a Person Responsible for Regulatory Compliance (PRRC) to ensure all regulatory obligations are fulfilled.

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Program: PRRC
Authority: EU MDR Art. 15 / IVDR Art. 15
Market: European Union
Delivery: End-to-end RA support

What it is

What is a PRRC?

The PRRC is a mandatory role introduced by Article 15 of the MDR and IVDR. The individual must hold specific qualifications and is responsible for ensuring the manufacturer complies with the regulations, especially:

Conformity of devices before release
Technical documentation and EU declaration of conformity
Post-market surveillance obligations
Vigilance reporting
Investigational device statements for clinical investigations

Why it matters

Why a qualified PRRC matters

Clear internal accountability and oversight
Lower risk of non-compliance and regulatory penalties
A demonstrably strong quality and regulatory culture
Effective communication with Notified Bodies and Competent Authorities

How we help

Our PRRC services

Acting as your official PRRC (outsourced model for micro and small enterprises)
Supporting internal PRRCs with compliance frameworks
Document review and sign-off assistance
Monitoring post-market and vigilance systems
Regulatory training for internal teams

Qualified experts

Specialists with strong MDR and IVDR experience.

Trusted & confidential

Secure handling of all regulatory data.

Integrated approach

Smooth coordination with your team and EU representatives.

Flexible options

Full-time support or an outsourced PRRC model.

The regulatory journey

From regulatory strategy to PRRC approval

01Framework identificationWe confirm the regulatory pathway that applies to your product and target market — MDSAP, MDR, FDA, TGA or MHRA.
02Regulatory strategyDevice classification, pathway selection and a realistic timeline to support launch planning.
03Technical documentationRisk management, clinical/performance evidence, labeling and QMS records built to each authority’s expectations.
04Submission and liaisonWe prepare and submit the application, manage questions from the authority or Notified Body, and track progress.
05Approval and market accessClearance, CE or UKCA marking, ARTG inclusion or registration, enabling your product to be placed on the market.
06Post-market complianceOngoing surveillance, vigilance, periodic updates and renewals to maintain compliance.

FAQ

PRRC frequently asked questions

01Who must have a PRRC?

Medical device manufacturers and authorized representatives under MDR and IVDR must have at least one PRRC available.

02What qualifications must a PRRC have?

A diploma in law, medicine, pharmacy, engineering or another relevant scientific discipline plus at least one year of regulatory or QMS experience with medical devices — or four years of such experience without a degree.

03Can we outsource the PRRC role?

Yes. Micro and small enterprises may have a PRRC permanently and continuously at their disposal rather than in-house — for example, through Lisora.

04Can one PRRC cover both MDR and IVDR?

Yes, provided the person is qualified under both regulations and responsibilities are clearly defined.

05What if we don’t have a PRRC?

It is a serious non-compliance under MDR/IVDR that Notified Bodies will raise and can lead to penalties or withdrawal of products from the EU market.

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