Since 1 January 2021, manufacturers based outside the United Kingdom must appoint a UK Responsible Person to place devices on the Great Britain market and to register with the MHRA.
Amstermed’s UK Responsible Person service is delivered from Belfast, providing dual-market visibility across Northern Ireland (where EU MDR continues to apply) and Great Britain (governed by the UK MDR 2002).
We manage MHRA registration, device listing, incident reporting and post-market obligations for the full range of general medical devices, active implantable devices, and in-vitro diagnostics.
Manufacturers based outside the United Kingdom.
Manufacturers using an EU Authorised Representative who require a separate UK entity.
Manufacturers preparing for the future UK regulatory framework (post-transition arrangements).
Distributors converting into virtual manufacturers under own-brand labelling.
Registering the manufacturer and devices with the MHRA and maintaining the UK device register.
Ensuring the Declaration of Conformity and technical documentation are drawn up and, where required, held for inspection.
Submission of Manufacturer Incident Reports and Field Safety Notices to the MHRA within statutory timelines.
Acting as the point of contact for the MHRA in relation to registered devices, complaints and enforcement.
Providing device samples or granting access to samples on request of the competent authority.
Coordinating dual placement under CE / UKCA / UKNI marking regimes as the framework evolves.
Registered address in Belfast providing physical UK presence for MHRA correspondence and inspection.
Consolidated view of Northern Ireland (EU MDR) and Great Britain (UK MDR) obligations.
Named regulatory specialist assigned to your manufacturer account through registration and post-market life.
Preparation and monitoring aligned with the MHRA’s future regulations roadmap.
General medical devices
Active implantable medical devices
In-vitro diagnostic medical devices
Software as a Medical Device
Custom-made devices
Reusable surgical instruments
Dental devices
Ophthalmic devices
Ten years after the last device covered by the Declaration of Conformity has been placed on the market. For implantable devices, the period is fifteen years.
Amstermed applies the same standard process to every representation and consulting engagement, adapted to the requirements of the specific jurisdiction.
The process is designed to make regulatory obligations legible, auditable, and durable. Each stage produces documentation that becomes part of the permanent mandate record.
Written inquiry received via encrypted email or Threema. Scope and jurisdictions are outlined. A mutual non-disclosure agreement is executed.
Existing regulatory documentation is reviewed: Declaration of Conformity, certificates, quality management evidence, labelling, and technical file summary.
Amstermed regulatory reviewers assess device classification, applicable regulation, and any gaps against the requirements of the target jurisdiction.
A written mandate is drafted defining scope, term, retention obligations, termination and successor provisions, in accordance with the applicable regulation.
The mandate is executed by both parties. Amstermed formally accepts the appointment and coordinates the manufacturer's regulatory particulars.
Notification is made to the competent authority: EUDAMED, MHRA DORS, Swissmedic, TGA ARTG, or FDA registration and listing as applicable.
From inquiry to registration, a straightforward mandate is typically completed within four to eight weeks, subject to the completeness of manufacturer documentation and authority processing times.
Where documentation is complete, the mandate can be executed within ten working days. Authority timelines are outside our control, but we can flag urgency where the framework permits
Not for the mandate itself. Site audits may be required by Notified Bodies or authorities for the manufacturer, independent of the representation mandate.
The mandate enters ongoing operation: vigilance, PMS, PSUR, PMCF where applicable, complaint handling and annual reviews. The process does not end at registration.
Regulatory obligations for United Kingdom Responsible Person are set out in the primary framework above, complemented by guidance documents issued by the relevant competent authority and applicable delegated or implementing acts.
Full regulation in force for new devices placed on the market.
Legacy devices subject to conditional continued placement, subject to specified conditions.
All devices in scope must comply with the current framework.
Our regulatory expertise covers a broad spectrum of medical devices and in vitro diagnostic technologies. We support manufacturers across multiple product categories, providing tailored regulatory guidance, documentation, and compliance strategies that align with the specific requirements of each device type and target market.
Contact us to learn more about our UK Responsible Person representation services and how we can help you meet UK regulatory requirements.