How do EU Authorised Representatives and UK Responsible Persons keep track of their mandates?

What the role carries

An EU Authorised Representative acts for a manufacturer based outside the EU under a written mandate. Under the EU MDR and IVDR the mandate covers duties such as checking that the declaration of conformity and technical documentation exist, keeping copies available to competent authorities, registration, answering authority requests, cooperating on corrective action, passing complaints and suspected-incident reports to the manufacturer, and ending the mandate if the manufacturer acts against its obligations. Read the current text of the regulation for your role; this list is a summary for planning, not a legal statement.

A manufacturer based outside the UK must appoint a single UK Responsible Person to place devices on the Great Britain market, and the UK Responsible Person takes on the manufacturer's responsibilities for registering those devices with the MHRA. US Agents and TGA Sponsors carry their own, different duties, so one firm holding several roles is running several rulebooks at once.

Why it breaks in spreadsheets

Each client brings its own identifiers, registrations and dates, and each duty needs evidence of when it was discharged. Spreadsheets hold the list but not the clock: nothing raises a renewal before it falls due, and nothing records that a complaint arrived on Tuesday and reached the manufacturer on Wednesday. When a manufacturer faces an audit, or an authority asks, that trail is rebuilt from email.

How Rep Hub holds a mandate

In SMEDTEC OS each client is its own workspace under your firm. A mandate is held against its role, which brings an obligation set in which each item cites the provision that creates it, for you to review and own. Identifiers sit with the registration they belong to; a deadline board and a daily sweep raise every date before it falls due; vigilance cases, authority requests and field safety actions are logged as they happen; and client contacts can be given read-only access to their own status.