EU Authorized Representative & PRRC services.

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.

Appoint FirsTeckBio in the EU

Tell us where you are based and your device class. We will confirm whether you need an EC-REP, a PRRC, or both, and how we can serve.