Who must have a PRRC?

Under EU MDR/IVDR Article 15, manufacturers and authorised representatives must have a PRRC with the required qualifications.

Do importers or distributors need a PRRC?

Importers and distributors are not required to appoint a PRRC, unless they also act as manufacturer or authorised representative.

Do I Need a PRRC (EU MDR/IVDR)?

Q: Can micro and small enterprises outsource the PRRC?

Yes. Micro and small enterprises can have a PRRC permanently and continuously at their disposal rather than within the organisation.

Q: What if I'm both manufacturer and EU AR?

You need at least one PRRC who can cover the responsibilities for both roles, or separate PRRCs if your structure requires it. The PRRC obligations under Article 15 must be fulfilled for all devices you are responsible for.

Use the quick eligibility tool below, then review the criteria and responsibilities. If you need a PRRC, Cruxi can match you with vetted PRRC providers.

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Under EU MDR and IVDR, manufacturers and EU Authorized Representatives must designate a Person Responsible for Regulatory Compliance (PRRC). Non-compliance can lead to enforcement and market access issues. Many companies—especially micro and small enterprises—use an external PRRC-as-a-service when they don't have a qualified person in-house.

On this page

Eligibility tool Core criteria PRRC responsibilities FAQ

Quick Eligibility Tool

Answer four questions for a directional view. This is not legal advice — use it to decide whether to consult a PRRC provider.

Are you a manufacturer placing medical devices or IVDs on the EU/EEA market? (Not sure? See the helper below.) Are you an EU Authorized Representative for a non‑EU manufacturer? (Not sure? See the helper below.) Are you only an importer/distributor (not a manufacturer or authorized representative)? Are you a micro or small enterprise under the EU definition? (Not sure? See the helper below.)

Core Criteria (EU MDR + IVDR Article 15)

Manufacturers and authorized representatives must have a PRRC with the required qualifications. Micro and small enterprises can use an external PRRC who is permanently and continuously at their disposal.^[1]^[2]

Not sure if you’re a manufacturer or authorized representative?

Use this helper to clarify your regulatory role.

Not sure if you qualify as micro/small enterprise?

Micro and small enterprises can have an external PRRC. If you’re unsure, confirm against the EU SME definition with finance or legal.

What the PRRC is responsible for

Under EU MDR Article 15 and IVDR Article 15, the PRRC is responsible for ensuring that the applicable regulatory obligations are met. In practice this includes:^[1]^[2]

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

The PRRC must have the required qualifications (university degree or equivalent in a relevant field, 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.

PRRC vs EU AR vs CH‑REP (Quick Comparison)

PRRC: A qualified person responsible for regulatory compliance inside the manufacturer or AR organization (MDR/IVDR Article 15).

EU Authorized Representative (EU AR): A legal entity in the EU/EEA appointed by non‑EU manufacturers to represent them under MDR/IVDR Article 11.

Swiss Authorized Representative (CH‑REP): A legal entity in Switzerland appointed by non‑Swiss manufacturers to access the Swiss market under MedDO/IvDO.

FAQ

Can the PRRC be external?

Yes, micro and small enterprises can use an external PRRC, but the person must be permanently and continuously at the organization’s disposal.^[1]^[2]

Do authorized representatives need a PRRC?

Yes. Authorized representatives must have a PRRC with the required qualifications.^[1]^[2]

Do importers/distributors need a PRRC?

Not unless they also act as manufacturer or authorized representative.

When do I need to appoint a PRRC?

You must have a PRRC designated before you place devices on the EU/EEA market (and before an EU Authorized Representative can act for you, if applicable). If you are already on the market without a designated PRRC, you are non-compliant and should appoint one as soon as possible.

What if I'm both manufacturer and EU AR?

If your organisation is the manufacturer and also acts as EU Authorized Representative for other (non-EU) manufacturers, you need at least one PRRC who can cover the responsibilities for both roles—or separate PRRCs if your structure requires it. The key is that the PRRC obligations under Article 15 are fulfilled for all devices you are responsible for.

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References

^[1] EU MDR Article 15 — PRRC requirements for medical devices.

^[2] EU IVDR Article 15 — PRRC requirements for IVDs.

EU MDR Article 15 · EU IVDR Article 15

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