The UK Competent Authority for medical devices, the MHRA, requires 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.
Following several months’ consultation with UK stakeholders, the newly-launched United Kingdom Authorised Representative Association (UKARA) was created to ensure that standards expected by the UK government are fulfilled by UK Authorised Representatives in the service of non-UK manufacturers.
The regulators expect UK Authorised Representatives who can competently represent manufacturers who are unfamiliar with UK law and who are eligible to practice in the UK. UKARA applies the highest standards to its membership admission and invites UKARs to join the Association to demonstrate their aptitude for the role.
UKARA members will be able to benefit from enhanced visibility and exposure as an accredited member organisation.
UKARA members must be fully compliant with the requirements set by the relevant regulatory bodies, ensuring consumers can continue to access safe and quality medical products in the UK. Individuals and companies who sign up to UKARA will need to put their services under intense, but necessary, scrutiny to demonstrate their quality, technical and regulatory competence.
UKARA believes that the professional conduct and competence of UK Authorised Representatives will be enhanced by UKARA. Considering the current lack of standardisation in the representation services’ field, this is believed to be a big step forward for all industry stakeholders.
About the United Kingdom Authorised Representative Association (UKARA)
The UKARA has far-reaching plans to create a register of professionals with a proven track record in the medical device regulatory field. Companies who sign up with UKARA may carry the UKARA seal on their website and publications.