PRRC List: The Reality

Why There Is No Official PRRC List

PRRC is a role—not a licensed or certified profession. Manufacturers designate someone (internal or external) who meets the qualification criteria. However:

• No EU authority maintains a registry of PRRCs or PRRC service providers
• There is no accreditation or certification program for PRRCs
• Qualification is based on education/experience—not a license

What the PRRC Role Entails in Practice

Under EU MDR Article 15 and IVDR Article 15, the PRRC is responsible for ensuring that the manufacturer (or authorised representative) complies with the regulation. In practice this typically includes:

• Conformity: Checking that devices conform to the applicable requirements before release
• Technical documentation: Ensuring technical documentation and the EU declaration of conformity are drawn up and kept up to date
• Post-market surveillance: Ensuring post-market surveillance obligations are complied with
• Vigilance: Ensuring reporting obligations (e.g. serious incidents, FSCA) are fulfilled

The PRRC must have the required qualifications: a university degree or equivalent in a relevant discipline, or sufficient professional experience in regulatory affairs or quality management. Micro and small enterprises can have an external PRRC permanently and continuously at their disposal.

When to Use PRRC-as-a-Service

Many manufacturers and EU Authorized Representatives use an external PRRC when they do not have a qualified person in-house. Common situations:

• Micro or small enterprises (SMEs): The regulation explicitly allows SMEs to have a PRRC permanently and continuously at their disposal—i.e. an external person who is available when needed
• Startups and small portfolios: Hiring a full-time regulatory expert may not be justified; a part-time or retainer PRRC service can cover the role
• IVDR-only or MDR-only focus: Some providers specialise in one regulation; others cover both—choose according to your portfolio
• Authorized Representatives: EU ARs must also have a PRRC; many ARs offer or partner with PRRC-as-a-service to fulfil this

How to Compare and Choose a Provider

Because there is no official list, due diligence is on you. When comparing PRRC-as-a-service providers, consider:

• Qualifications: Confirm the person(s) meet the MDR/IVDR Article 15 requirements (degree or equivalent, or sufficient experience in regulatory/quality)
• Coverage: MDR only, IVDR only, or both—match to your device types
• Scope: Conformity checks only, or also support with technical documentation, PMS, vigilance
• Availability: Response times and how "permanently and continuously at disposal" is contractually defined for SMEs
• Contract: Clear mandate, confidentiality, liability, and duration

Request quotes from several providers and compare coverage, experience, and pricing. Cruxi's directory helps you discover and compare vetted providers in one place.

Cruxi Vetted PRRC-as-a-Service Providers

Cruxi maintains a directory of verified PRRC-as-a-service providers. Important: These providers are not "official" or "approved" by any authority—they are verified service providers. Always do your own due diligence and confirm qualifications and scope before appointing a PRRC.

FAQ

Is there an official PRRC list?

No. There is no official PRRC list or registry. The PRRC is a designated role under EU MDR Article 15 and IVDR Article 15. Manufacturers must designate a person who meets the qualification requirements. There is no certification body or public list of PRRCs or PRRC service providers.

What qualifications must a PRRC have?

Under MDR/IVDR Article 15, the PRRC must have a university degree or equivalent in law, medicine, pharmacy, engineering, or another relevant scientific discipline, plus at least one year of professional experience in regulatory affairs or quality management; or at least four years of professional experience in regulatory affairs or quality management. Confirm with your provider that the designated person meets these criteria.

Can one PRRC serve multiple manufacturers?

Yes. The same person can be designated as PRRC for more than one manufacturer or authorised representative, provided they can fulfil the role "permanently and continuously" for each. Many PRRC-as-a-service providers act for multiple clients. The key is that the person is at the organisation's disposal when needed and can carry out the Article 15 responsibilities.

Does the UK require a PRRC?

UK MDR 2002 (as amended) and UK IVDR include a similar "person responsible for regulatory compliance" role. If you place devices on both the EU and UK markets, you need to meet the requirements in each jurisdiction. Some providers offer both EU and UK PRRC support; confirm scope when requesting quotes.

Where can I find PRRC-as-a-service providers?

Cruxi maintains a directory of verified PRRC-as-a-service providers. You can compare providers and request quotes—this is not an official list but a curated directory for comparison. Always verify qualifications and scope before appointing a PRRC.