New Standard on Management System Specifications Published by UK Authorised Representative Association UKARA

London, United Kingdom, October 23, 2021 --(PR.com)-- The UK Competent Authority for medical devices, the MHRA, has advised that manufacturers not domiciled in the UK must appoint a formal UK Responsible Person (UKRP) or UK Authorised Representative (UKAR) to be able to continue placing medical devices on the UK market.

However, most recognised management systems are unsuitable or are not intended to specify the role and practices of UK Authorised Representatives. The new standard UKARAS 001:2021 – UK/GB Responsible Person/Authorised Representative – Management System Specification published by the UK Authorised Representative Association (UKARA) is motivated by the need for a uniform management system which can subsequently be assessed uniformly.

The standard describes, for instance, the need for formally designated duties, an adjusted organisational structure, processes and operations to accommodate the role of the UKRP/UKAR, training and education requirements, also procedures in the event of an authority inspection, among others.

Compliance with the standard is mandatory for all UKARA members.

The standard is complimentary to UKARA members. Non-members can purchase it priced at £95 (plus VAT).

UK Authorised Representatives interested in joining the Association should contact UKARA by email enquiries@ukara.org or apply via https://ukara.org.