The MDCG 2019-07 Rev.1 guidance, published in December 2023, provides an important clarification on the relationship between the roles of EC REP authorised representative and PRRC. Its position is unambiguous: a single entity cannot perform both functions simultaneously for the same manufacturer.
Yet this arrangement is common. EC REP service providers offer the PRRC plus EC REP bundle within a single contract. Non-EU manufacturers believe they are optimising their organisation by centralising both functions with the same provider. The MDCG 2019-07 Rev.1 guidance points out that this arrangement is problematic.
The MDCG’s reasoning
The PRRC (Article 15 MDR) is responsible for ensuring that the manufacturer’s regulatory obligations are actually met. The PRRC works under the manufacturer’s authority, embedded within its organisation or bound to it by contract.
The EC REP (Article 11 MDR) is an economic operator distinct from the manufacturer, designated to represent the latter before the European authorities. It assumes its own obligations, separately from the manufacturer.
If a single entity is both PRRC and EC REP, it ends up in a structurally contradictory position: it must both implement the manufacturer’s obligations (PRRC role) and independently ensure that they are met (EC REP role). This conflict of interest makes it impossible to perform each role independently and effectively.
The exact wording to keep in mind
The non-compliance does not stem directly from an MDR article that would explicitly prohibit combining the roles. It stems from the interpretation of Article 15 MDR within the framework of MDCG 2019-07 Rev.1. The correct wording is therefore: “arrangement at risk according to MDCG 2019-07” or “non-compliance with MDCG 2019-07 within the framework of the interpretation of Article 15 MDR”.
Writing “non-compliance with Article 15(6) MDR” would be legally inaccurate — Article 15(6) does not concern this prohibition.
What it means for the non-EU manufacturers concerned
A non-EU manufacturer that has organised its regulatory setup by entrusting the EC REP and PRRC roles to the same entity must change this organisation. Two options are available.
Designate a PRRC internal to the manufacturer (within its team), who remains distinct from the external EC REP.
Use two separate providers: one for the EC REP role, the other for the PRRC role.
This change must be documented and traceable. Notified bodies and competent authorities may verify the manufacturer’s regulatory organisation during an audit or an inspection.
Regulatory source: MDCG 2019-07 Rev.1 — health.ec.europa.eu