The UK Responsible Person Association (UKRPA) was set up in December 2020 to promote professional conduct and competence among companies and persons performing the role of a UK Responsible Person as defined in the Medical Devices Regulations 2002.

There are no specific requirements regarding the qualifications or the competence of the UK Responsible Person (UKRP). Yet the responsibilities of the UKRP suggest the need for a good understanding of regulatory requirements for medical devices and commensurate experience to comply with them.

The founding members of UKRPA are all companies specialising in providing regulatory services to medical device manufacturers worldwide. All have a wealth of experience as authorised representatives, a role akin to that of the UKRP. Collectively they have provided professional services to thousands of manufacturers.        

Our doors are open to all companies and persons who act as a UKRP. We aim to foster a spirit of professionalism and excellence among our members.

We are cooperating closely with the Medicines and Healthcare products Regulatory Agency (MHRA) to enhance transparency and understanding of the regulatory requirements in our field.

Mika Reinikainen, LL.M., MBA, MTopra                        

Chairman

UKRPA