Person Responsible for Regulatory Compliance (PRRC) Services

ARTICLE 15 REGULATORY OVERSIGHT

The MDR and IVDR require manufacturers and authorised representatives to have qualified regulatory-compliance expertise available. MEDAGENT provides PRRC support that connects product release, technical documentation, post-market surveillance and vigilance obligations to one clearly defined regulatory role.

What is a PRRC?

The Person Responsible for Regulatory Compliance is the qualified person defined in Article 15 of the MDR and IVDR. The role helps ensure that device conformity is checked before release, technical documentation and declarations remain up to date, post-market surveillance is performed and required reporting obligations are fulfilled.

Manufacturers generally need the PRRC within their organisation. Micro and small enterprises are not required to employ the person internally, but must have qualified support permanently and continuously at their disposal. Authorised representatives must also have a qualified PRRC permanently and continuously available.

What MEDAGENT supports

  • Define the PRRC scope, responsibilities and written interfaces with your team.
  • Provide qualified oversight appropriate to the agreed MDR or IVDR role.
  • Review the connection between product release and the quality management system.
  • Support technical-documentation and Declaration of Conformity controls.
  • Monitor post-market surveillance and vigilance responsibilities.
  • Advise on regulatory changes, training needs and documentation gaps.
Discuss your PRRC requirement
How the Process works

4 Easy Steps to your successful launch in Brazil!

1. Enquire About Our Service

Let us know what services you’re interested in.
Enquire about specific services with us and get connected with one of our experts.

2. Getting Connected

We’ll follow up on your enquiry via your preferred contact method.
You’ll receive a tailored quote, service overview, and global launch support plan.

3. Send Us Required Documents

Complete the Checklist & Submit Documents.
We take care of the administrative processing and submit the necessary documents.

4. Finalization & Launch

Successful Approval & Ongoing Support.
After approval, we provide ongoing regulatory updates and support tailored to your requirements. We’re also available to assist with any additional needs as they arise.
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Experienced, Versatile Regulatory Support

MEDAGENT brings more than 25 years of medical-device regulatory and quality experience to its PRRC service. The model is designed for both growing companies that need continuous external expertise and established organisations that want stronger oversight or additional capacity.

The service should be tailored to the organisation and documented clearly. A PRRC is an active compliance role, not a nominal appointment.

Frequently asked questions

What qualifications must a PRRC have?

Article 15 sets qualification and experience routes, including a relevant degree plus regulatory or quality experience, or a defined period of professional experience. The exact evidence should be assessed for the individual and device field.

Can a PRRC be outsourced?

Micro and small manufacturers may have an external PRRC permanently and continuously at their disposal. Other manufacturers generally need the role within their organisation. Authorised representatives have their own Article 15 obligation.

Is a PRRC the same as an EU Authorised Representative?

No. The authorised representative is an EU economic operator acting under a mandate for a non-EU manufacturer. The PRRC is the qualified regulatory-compliance role required by Article 15.

Can one person cover every responsibility?

Responsibilities can be shared, but the respective areas must be stipulated in writing. The arrangement must provide appropriate expertise and real availability.

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Stay Updated on Regulatory Changes

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MEDAGENT helps medical device manufacturers navigate regulatory requirements, quality management and compliant market entry across international markets.

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Griesweg 47
78570 Mühlheim
Germany

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