EU Representation & PRRC

EU Authorized Representative (EC-REP)

The mandatory EU-based point of contact for non-EU manufacturers under IVDR Article 11.

• Designated EU presence: We act as your registered EU Authorized Representative, named on labelling and in EUDAMED.
• Authority interface: Reception of vigilance and competent-authority communications across the EU on your behalf.
• Technical-file verification: We verify that technical documentation and the EU declaration of conformity are in place, as the regulation requires.

PRRC (Article 15)

The qualified person every IVD manufacturer must have available — outsourced for small and micro companies.

• Outsourced PRRC: An outsourced Person Responsible for Regulatory Compliance for manufacturers where in-house qualified resources are scarce or costly.
• Compliance oversight: Oversight of conformity, technical documentation, post-market surveillance and vigilance obligations.
• Qualified personnel: Staffed by personnel meeting the IVDR experience and qualification requirements.

EU, UK & Switzerland

Placing an IVD across European markets means more than one representative role — each jurisdiction has its own.

• EC-REP (European Union): EU Authorized Representative under IVDR Article 11 — our core service, based in Italy.
• UKRP (United Kingdom): UK Responsible Person coordination for the UKCA / Great Britain market, via established partners.
• CH-REP (Switzerland): Swiss Authorized Representative coordination for the Swiss market, via established partners.

Do you need a representative?

A quick way to self-assess your obligations.

• Manufacturer outside the EU: You must appoint an EU Authorized Representative before placing devices on the EU market.
• Small or micro manufacturer: You likely benefit from an outsourced PRRC rather than hiring a full-time qualified person.
• Representation is infrastructure: For non-EU manufacturers, representation is not just an address — it is part of the regulatory and documentation infrastructure needed to operate in Europe.

Discuss your European representation

Tell us where the manufacturer is based and which products and markets are involved.