Authorised Representative for Medical Devices and IVDs
Manufacturers of medical devices, in vitro diagnostic (IVD) medical devices, and Software as a Medical Device (SaMD) must comply with market-specific regulatory requirements in each jurisdiction where their products are supplied. These requirements may include the appointment of a local Responsible Person or Authorised Representative, depending on the market.
Products placed on the Great Britain market must be supported by a UK-based Responsible Person, while access to the European Union market requires the appointment of an EU-based Authorised Representative, in accordance with applicable EU regulations.
Beyond the UK and EU, we provide Authorised Representative services across multiple international markets, supporting manufacturers with local regulatory representation, product registration, and ongoing compliance in line with country-specific requirements.
Where an existing Authorised Representative is based in the UK, a separate EU Authorised Representative must be appointed to continue supplying devices within the EU. Applicable products must also be registered according to their risk classification, with transitional provisions available for certain device categories.
Ensure ongoing compliance and continuity of market access through the appropriate regulatory representation.
