The UK Responsible Person Association


The UK Responsible Person Association (UKRPA) was established soon after the implementation of Brexit to represent and promote the newly created profession of UK Responsible Person (UKRP). All non-British manufacturers of medical devices must designate a UKRP if they place their devices on the British market (England, Scotland and Wales). The main obligation of the UKRP is to register the products of the manufacturers that they represent, however current and likely future requirements suggest a much more complex role for these new professionals. The UKRPA intends to facilitate this role by ensuring good communications with the competent authority, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), and providing relevant resources to its members (information, best practices, etc).

Whenever the law creates a new legal being, the creation of an association to defend its interests seems to automatically follow. Thus, we have associations such as the European Association of Medical Devices Notified Bodies (Team NB), the European Association of Authorised Representatives (EAAR) and Person Responsible for Regulatory Compliance (Team-PRRC). The UKRPA is no different. Brexit begat the UK Responsible Person, and this became a legal obligation on the 1 January 2021 for non-British manufacturers placing their medical devices on the British Market. UKRPA was officially incorporated on 19 April 2021 in England as a private limited company by guarantee.

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