CONSULTANCY /

PRRC (Person Responsible for Regulatory Compliance)

Sleep easy knowing compliance is taken care of
Your regulatory obligations are complex. we ensure they’re handled. Appointing a qualified PRRC through us protects your business, keeps regulators satisfied, and frees your team to focus on growth — without micromanaging compliance.

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PRRC responsibilities can be complex

The PRRC role adds to ever increasing regulatory requirements

Our team have the specific qualifications and professional experience for the PRRC role
Our team ensure your regulatory deadlines are not missed

We safeguard your business. We act with authority, accountability, and experience.

Why we’re trusted

PRRC support should do more than meet a requirement.
We actively protect your business and support growth.

1. Accountability

We take responsibility for regulatory compliance.

2. Expertise

We've guided manufacturers to smooth regulatory outcomes.

3. Effectiveness

Compliance handled correctly the first time means fewer delays, smoother audits, and peace of mind.

4. Integration

We work with your team and systems to ensure compliance fits into your business, not the other way around.

Our PRRC service provides clear accountability, fast regulatory responses, continuous support, and reduced risk- giving you confidence and peace of mind in EU and UK markets.

Our onboarding process is quick & simple

Clear, structured, and regulator-ready.
1

Initial Consultation

We assess your devices and regulatory requirements.
2

Documentation Review

We review required regulatory documents to ensure compliance and accessibility.
3

Formal Appointment

You appoint CompliantMD as your PRRC.
4

Ongoing Support

We integrate into your compliance processes, handling reporting, vigilance, and audits.
Need us to sign an NDA? Feel free to download our template.

Who this service is for

Medical device and IVD manufacturers
Quality and regulatory teams with limited resources
Start-ups requiring regulatory expertise

Frequently Asked Questions

If you manufacture and sell into the EU you must have a PRRC.
If you are based in the EU then this PRRC should reside in the EU also.
If you are based outside the EU, then your PRRC should reside outside the EU.
CompliantMD can provide PRRC services either inside or outside the EU.

We will require access to all of your technical and quality documentation.

The PRRC is responsible for ensuring compliance with the EU Medical Device Regulation on your behalf.

Yes, start-ups in particular are stretched as staff take on multiple roles and strive to expand according to their business plan. CompliantMD can make this process easier by providing professional, ready made expertise for a growing business.

Yes. We can support all of your medical devices and IVDs.

Yes, we can help you with consultancy on device documentation, training of staff or internal auditing.

Book a PRRC consultation today

Let's make your regulatory compliance straightforward, reliable, and stress-free.