UK Responsible Person (UKRP) Support Services

As the United Kingdom is no longer part of the European Union, an EU Authorised Representative is no longer recognised in Great Britain (England, Scotland and Wales). The MHRA requires its own version of a “UK Authorised Representative”, called a UK Responsible Person (UKRP). Northern Ireland, the fourth UK country, still requires an EU Authorised Representative. As of 1 January 2022, non-UK-based manufacturers are legally required to appoint a UK Responsible Person (UKRP) to act on their behalf with UK Regulators in order to place their medical devices on the market in the UK.

It is important for manufacturers to select the appropriate UK Responsible Person (UKRP) and working with an independent party can help avoid conflicts with current distribution or import agreements. Partnering with QAEC Limited as your UKRP meets both of these requirements.

If you are looking for a UKRP to help maintain, or launch a Medical Device or IVD on the UK market, QAEC Limited are here to support you, helping you ensure that Article 15 of the UK MDR and IVD is being maintained.

As a medical device and in vitro diagnostic manufacturer we can provide you with guidance and support you need:

• Registering your devices with the MHRA
• Making sure that the Declaration of Conformity and technical documentation have been prepared
• Conduct Internal Audits
• Attend Management Review
• Act as your representative in the UK

As your UKRP, we will represent your business efficiently and with complete regard for patient safety and your company’s reputation.

Contact us today at +44 (0)1452 341913 or email us at enquiries@qaeclimited.co.uk so we can discuss your requirements and assist you in ensuring that your products are compliant and on sale.