top of page

Authorized Representative for Medical Devices in the United Kingdom

We act as Authorized Representatives of medical devices in the United Kingdom. We prepare the documentation for your subsequent MHRA registration and advise you on the process of obtaining the UKCA marking.

UKCA Marking: Regulatory Compliance

The UKCA (United Kingdom Conformity) marking is essential to demonstrate that products meet British safety and quality standards. Working with an Authorized Representative can facilitate this process by providing guidance on specific requirements.

Marcado UKCA.png
united-kingdom-156243_1280.png

How does the UKCA marking process affect you?

The two key points of immediate impact for you as a manufacturer are

  • Product registration:All medical devices and IVDs placed on the market in Great Britain must be registered with the MHRA. Where applicable, details of conformity assessment by a UK approved body for UKCA, or an EU notified body for EC, must be provided during product registration. Please note that registration requirements differ for Northern Ireland.

​

  • UK Responsible Person: If you are located outside the UK, you will need to appoint a UK Responsible Person (UKRP), located in the UK. UKRP's responsibilities will include registering its products with the MHRA.

UKCA

UKCA certification and EU MDR/IVDR alignment

Due to Brexit, the MHRA has indicated that medical device and IVD regulations will be closely aligned with the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR).
Devices marked European Conformity (CE) will initially be recognized in the UK, but manufacturers will need to obtain UK Conformity Assessment (UKCA) certification from July 2023.

REGISTRO MHRA.png

MHRA Registration: Step by Step

Registration with the Medicines and Healthcare products Regulatory Agency (MHRA) is a fundamental step for the marketing of healthcare products in the UK. Here are the essential steps for registration:

  • Documentation Preparation:Compilation of necessary documentation, which may include evidence of compliance with British Standards.
     

  • Appointment of Authorized Representative: Appoint an Authorized Representative with experience in UK regulation.
     

  • Registration Request: Submit the registration application through the MHRA online system.
     

  • Evaluation and Approval:MHRA will review the application and assess the documentation provided. Once approved, a registration number is issued.

Responsible Person in the United Kingdom

UK PR Services for Medical Devices

Following Brexit, the Medicines and Healthcare products Regulatory Agency (MHRA) requires manufacturers based outside the UK to appoint a UK Responsible Person (UKRP). A UKRP is essentially an Authorized Representative for manufacturers of Medical Devices and will generally fulfill the same role. UKCA Experts, part of Certification Experts, will represent you as your UK Responsible Person (UKRP) under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR). 

bottom of page