PRRC vs Authorised Representative vs Importer: Who Does What Under EU MDR
Quick answer: Under EU MDR (2017/745), the PRRC is an internal compliance role every manufacturer must fill (Article 15); the authorised representative (AR) is an EU-established legal proxy that non-EU manufacturers must appoint (Article 11); the importer places devices from third countries on the EU market (Article 13); and the distributor makes devices available downstream (Article 14). They are not interchangeable, and a non-EU manufacturer typically needs a PRRC and an AR — and the AR needs its own PRRC too.
The four economic operator roles at a glance
Manufacturer (Article 10). Holds full responsibility: QMS, technical documentation, CE marking, post-market surveillance, vigilance. Must have a PRRC available.
Authorised representative (Article 11). Mandatory for manufacturers established outside the EU. The AR is established in the EU, holds a written mandate, verifies that the declaration of conformity and technical documentation exist, keeps documentation available for competent authorities, and is legally liable, jointly and severally with the manufacturer, for defective devices in defined circumstances. The AR's name appears on the label.
Importer (Article 13). The EU-established operator placing a third-country device on the EU market. Verifies CE marking, declaration of conformity, AR designation, labelling, and UDI assignment; adds its name to the device or accompanying documentation; keeps a register of complaints and non-conforming devices.
Distributor (Article 14). Makes devices available on the market after import. Verifies CE marking and label compliance, ensures storage/transport conditions, and forwards complaints up the chain.
Where the PRRC fits
The PRRC is not an economic operator — it is a person with verification duties inside (or contracted to) two of them:
Every manufacturer must have a PRRC available (Article 15(1)); micro and small enterprises may contract one externally (Article 15(2)).
Every authorised representative must also have a PRRC permanently and continuously at its disposal (Article 15(6)).
Importers and distributors do not need a PRRC.
The structure non-EU manufacturers get wrong
A common mistake: a US or UK manufacturer appoints an AR and assumes the AR "handles compliance." It doesn't. The AR verifies that documentation exists; the manufacturer's PRRC verifies that devices conform. A second mistake: rolling AR, importer, and PRRC into one lightly-resourced entity. The MDR permits one company to hold AR and importer roles, but each role's obligations must be independently discharged and evidenced — and conflicts of interest surface fast in audits.
The clean structure for a non-EU SME is usually: an AR with genuine document-holding capability, an importer (possibly your EU distributor), and a contracted external PRRC with real access to your technical file and release process.
Side-by-side summary
PRRC — required for all manufacturers and authorised representatives; a person, not an EU-established entity; verifies conformity, technical documentation, PMS, and vigilance.
Authorised representative — required for non-EU manufacturers; established in the EU; needs its own PRRC; legal proxy, document holder, joint and several liability.
Importer — required for third-country devices; established in the EU; no PRRC needed; verifies compliance before placing devices on the market.
Distributor — downstream supply; established in the EU; no PRRC needed; verifies CE marking, storage and transport conditions, forwards complaints.
Frequently asked questions
Can our AR act as our PRRC? No — the AR needs its own PRRC (Article 15(6)), and the manufacturer needs one too. One person holding both creates a conflict: the AR's PRRC is part of the check on the manufacturer.
We're an EU manufacturer. Do we need an AR? No. ARs are only for manufacturers established outside the EU. You still need a PRRC.
Can one company be both importer and AR? Yes, if it discharges both sets of obligations separately. Document each role's activities independently.
Who do competent authorities contact first? For non-EU manufacturers, the AR — that is its function. Vigilance obligations, however, remain the manufacturer's, verified by the PRRC.
About QLE Group
QLE Group is a Brussels-based regulatory practice providing external PRRC mandates, EU regulatory strategy, and outsourced RA/QA infrastructure under EU MDR and ISO 13485:2016. Mandates are held personally by Radoslav Milkov (qualified PRRC, ISO 13485 / 21 CFR 820 Lead Auditor, LL.M. EU Law, European Commission external expert) and are PI-insured. Pricing is complexity-indexed and published at qle.be.
Structuring EU market entry? Book a scoping call or email info@qle.be.
