UK Representative
The UK representative serves as the point of contact for UK regulatory authorities, including the Medicines and Healthcare products Regulatory Agency (MHRA), on behalf of the manufacturer. This is particularly important if the manufacturer is not based in the UK.
Who needs to appoint a UK representative?
The requirement to appoint a UK representative typically applies to non-UK manufacturers, importers, or distributors of certain products or services who do not have a physical presence or legal entity established in the United Kingdom (UK).
Why an UK Authorised Representative?
The UK requires companies to assign a local entity responsible for product compliance information. Once designated, the UK Authorised Representative becomes the main contact person for the market surveillance authorities and should be able to:
Verify the UK Declaration of Conformity as issued by the manufacturer
Verify the technical documentations as compiled by the manufacturer
Keep the documentation for the period required by the legislation
Liaise with manufacturer and support in case of non-compliance risk
Provide manufacturer with the name and contact details to be included on the the product, packaging, or labelling
Responsibilities of UK Representative
The representative facilitates communication between the manufacturer and UK authorities, ensuring that all necessary information, documentation, and reports required by UK regulations are provided in a timely manner. The UK representative assists the manufacturer in ensuring that the medical devices comply with the requirements of UK regulations, such as the UK Medical Devices Regulations (UK MDR). This includes conformity assessment procedures, technical documentation, labelling, and post-market surveillance. The representative is responsible for reporting adverse events, incidents, and field safety corrective actions related to the medical devices to the MHRA.
MHRA Registration
MHRA stands for the Medicines and Healthcare products Regulatory Agency. It is the regulatory body in the United Kingdom responsible for ensuring that medicines and medical devices meet appropriate standards of safety, quality, and efficacy.
Why required for export to UK?
If you are exporting medicines or medical devices to the UK, you may need to register with the MHRA. This registration is part of the regulatory requirements to ensure that the products entering the UK market comply with the necessary standards.
How to register?
To register with the MHRA, you typically need to follow these general steps:
Check if Registration is Required: Determine whether your product requires registration with the MHRA. This information may depend on the type of product and its classification.
Prepare Documentation: Gather all necessary documentation related to your product, including information on its safety, quality, and efficacy.
Submit Application: Submit your application for registration to the MHRA. The specific details and forms required will depend on the type of product you are exporting.
Who needs to register with the MHRA?
Entities involved in the manufacturing, distribution, import, or wholesale trade of medicinal products, medical devices, or active pharmaceutical ingredients (APIs) in the United Kingdom are typically required to register with the Medicines and Healthcare products Regulatory Agency (MHRA). This registration process applies to various sectors within the healthcare industry.
Benefits of MHRA registration
MHRA (Medicines and Healthcare products Regulatory Agency) registration offers several key benefits for manufacturers and distributors of medicinal products and medical devices. Registration with MHRA is essential for legal market access in the UK, demonstrating compliance with rigorous regulatory standards regarding safety, quality, and efficacy. This not only ensures adherence to UK legislation but also instills trust and confidence among consumers and healthcare professionals regarding the reliability and effectiveness of registered products.