Regulatory Representation

Appoint SMEDTEC as Your UK or EU Authorised Representative

Non-UK and non-EU manufacturers must appoint a UK Responsible Person and/or EU Authorised Representative. SMEDTEC provides both — with active oversight, not just a name on a document.

UKRP (UK Responsible Person)

For non-UK manufacturers selling in Great Britain

  • ·Required under UK MDR 2002 and MHRA regulations post-Brexit
  • ·We register on your behalf with the MHRA
  • ·Active obligations management — not just a letterbox service
  • ·Annual service with renewal included
  • ·Direct point of contact for MHRA communications

EU AR (EU Authorised Representative)

For non-EU manufacturers under EU MDR / IVDR

  • ·Required under EU MDR 2017/745 and IVDR 2017/746
  • ·EUDAMED registration and ongoing management
  • ·Competent authority liaison included
  • ·Post-market obligation monitoring
  • ·Annual review and proactive compliance updates
Why Us

Active oversight. Not a letterbox.

Regulatory experts, not a filing service

Our representatives are practising regulatory professionals who understand your obligations and anticipate changes before they affect you.

Direct access, always

You'll deal with the same person, not a call centre. We're embedded in your compliance, not processing you at arm's length.

Proactive, not reactive

We monitor regulatory updates relevant to your device and market, flagging issues before they become problems.

Get Started

Tell us about your device