Guide · UK Responsible Person

How do UK Responsible Person firms keep track of their obligations?

By holding each client as its own mandate record: the designation and the devices it covers, the UK Responsible Person duties that come with it, the MHRA registration details held under it, every recurring date, and a log of each occasion a duty was discharged, such as a complaint passed to the manufacturer or an MHRA request answered. The duties are the same for every client; the devices, dates and evidence are not. That is why UK RP firms holding more than a few designations stop relying on a spreadsheet and an inbox.

Last reviewed 3 November 2026 · SMEDTEC

What a UK Responsible Person is answerable for

A manufacturer based outside the UK that places devices on the Great Britain market must designate a single UK Responsible Person, who takes on the manufacturer's responsibilities for registering those devices with the MHRA. Under the UK Medical Devices Regulations 2002, as amended, the role's tasks broadly mirror an EU Authorised Representative's: making sure the declaration of conformity and technical documentation exist, keeping copies available to the MHRA, answering MHRA requests for information and documentation, cooperating on preventive and corrective action, passing complaints and incident reports from healthcare professionals and patients to the manufacturer, and ending the designation if the manufacturer acts against its obligations.

This is a planning summary, not a legal statement. Confirm the current requirement against the regulations and MHRA guidance for the devices you represent.

Where the obligations hide

The duties are easy to list. What slips is the evidence that each one was discharged, client by client.

  • Registered devices that change when a manufacturer adds, changes or withdraws products
  • Complaints and incident reports that must reach the manufacturer, with the time it took on record
  • MHRA requests for information and documentation, each with a response you can show
  • Changes to the UK Responsible Person's own details across every registration it holds
  • The end of a designation, which carries its own steps

How Rep Hub holds a UK RP mandate

Each client designation is a mandate held against the UK Responsible Person role. The role brings an obligation set in which each item cites the provision that creates it, for your firm to review and own. MHRA registration details sit with the registration they belong to; a deadline board and a daily sweep raise every date before it falls due; vigilance intake, the authority communication log and field safety actions record each occasion a duty was discharged.

Firms that work from an AI assistant can ask what is due across every mandate, complete a deadline or log a new vigilance case through the SMEDTEC OS connector.

A good fit for

  • Firms acting as UK Responsible Person for several overseas manufacturers
  • Firms holding UK RP and EU AR designations for the same clients

Not the right tool for

  • Filing registrations: SMEDTEC OS tracks them, and the filing is made in the MHRA's own registration system
  • Firms wanting the platform to carry the legal responsibility: meeting the obligations stays with the UK Responsible Person

Common follow-up questions

Who must appoint a UK Responsible Person?

A medical device manufacturer based outside the UK that places devices on the Great Britain market. Manufacturers based in the UK register their own devices with the MHRA. Northern Ireland follows different rules, so check current MHRA guidance for devices placed there.

Can a UK Responsible Person firm see every client's deadlines in one place?

Yes. In Rep Hub each manufacturer is a client with its own UK RP mandate, obligation set, registrations and dates, and the deadline board shows every clock across all of them at once, with overdue items always visible.

What does it cost to run UK RP mandates on SMEDTEC OS?

The Firm plan is £149 a month with five mandates included and £1.50 a month for each mandate beyond that; Firm Plus is £349 a month with twenty-five. A one-person firm can start on the Free plan, which includes one mandate.

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