PRRC vs EC REP

PRRC – Person Responsible for Regulatory Compliance

The acronym PRRC comes from the English term Person Responsible for Regulatory Compliance. Person Responsible for Regulatory ComplianceThis individual is responsible for ensuring regulatory compliance of medical devices, including:

— Ensuring that devices meet regulatory requirements before being placed on the market;

— Keeping technical documentation up to date;

— Overseeing post-market surveillance activities;

— Confirming that all reporting and notification obligations are fulfilled.

Manufacturers with more than 50 employees or annual revenue exceeding €10 million must appoint an internal PRRC. Smaller manufacturers may outsource this role, for example, through a specialised consultancy.

EC REP – Authorised European Representative

The EC REP (or European Authorised Representative) is mandatory only when the manufacturer is located outside the European Union. In this case, a European representative must be appointed to act as the official intermediary between the manufacturer and the competent authorities. This economic operator:

— Must be clearly indicated on product labelling (including the mandatory symbol);

— Holds a copy of the device’s technical documentation;

— Communicates with authorities on behalf of the manufacturer;

— Participates in corrective and surveillance actions when required.

Choosing an EC REP requires careful consideration, as the representative’s competence and reliability can significantly impact regulatory compliance effectiveness and risk mitigation, including potential corrective measures, product recalls, or penalties.

Regulatory Significance

In an increasingly regulated market, appointing a competent EC REP and PRRC is not merely a legal requirement—it is also a way to ensure safety, traceability, and ongoing compliance. 

These professionals and entities serve as the vital link between the manufacturer and the European regulatory system, playing a crucial role in preventing sanctions, recalls, or market suspensions.

Thus, both the PRRC and EC REP perform structural functions in meeting the requirements set out by EU medical device legislation. 

Their timely and effective integration into a company’s regulatory strategy is essential to securing sustainable access to the EU market and maintaining compliance throughout the entire device lifecycle