Establish your regulatory representation in Great Britain

For overseas manufacturers requiring a UK Responsible Person, we help assess and establish an appropriate representation arrangement, subject to due diligence and a written mandate.

Our support can include:

Reviewing manufacturer and device information before an appointment.

Defining the UKRP mandate, responsibilities and communication arrangements.

Coordinating the information required for MHRA device registration.

Reviewing the availability of relevant conformity and technical documentation.

Establishing processes for regulatory enquiries and escalation of post-market matters.

Planning updates when device or manufacturer information changes.

What you can expect: An onboarding checklist, an agreed responsibility framework and a registration and communication plan.

The manufacturer retains its applicable obligations. Great Britain and Northern Ireland have different regulatory arrangements, which must be assessed separately.