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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.

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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.

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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). 

  • EU Responsible Person and UK Responsible Person
    Another important aspect of regulation is that of the responsible person. In Europe, the responsible person is someone who has legal responsibility for ensuring that a product meets legal requirements. The same goes for the UK responsible person in the UK. Experts in cosmetics and healthcare product regulation can help companies understand the roles and responsibilities involved in this process.
  • CPNP and SCPN and PIF registration
    CPNP Registration (Cosmetic Product Notification Portal) is a legal requirement for cosmetic products in Europe. SCPN is the UK equivalent. In order to register on these portals, detailed information about the product is required, including ingredients and formulations. Experts in cosmetics and healthcare product regulation can help companies complete these registrations and ensure they are complying with legal requirements.
  • Technical dossier for product authorization in Europe
    A technical dossier is a document that describes the technical and safety aspects of a product. ​ It is a legal requirement for most cosmetic and health products in Europe. Experts in cosmetics and medical device regulation can help companies complete a technical dossier for product authorization in Europe.
  • Who is responsible for the regulation of cosmetic products in Europe?
    In Europe, the regulation of cosmetic products is the responsibility of the European Commission, which establishes regulations and requirements to guarantee the safety and quality of the products that are marketed
  • What are the requirements that a cosmetic product must meet in order to be marketed in Europe?
    A cosmetic product must comply with a series of requirements established in European Regulation 1223/2009. These requirements include aspects related to safety, labeling, permitted ingredients, animal testing and prior notification before marketing.
  • What products are not considered cosmetics according to European Regulation 1223/2009?
    According to European Regulation 1223/2009, products that have a medical purpose, such as medicines, medical devices or health products, are not considered cosmetics. These products are regulated by other specific regulations.
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