Compliance for the United Kingdom Market
Following Brexit, the United Kingdom introduced the UKCA (UK Conformity Assessed) marking as the mandatory compliance requirement for products placed on the market in Great Britain (England, Scotland, and Wales). Manufacturers must now align with UK-specific regulatory frameworks, which differ in certain aspects from EU CE requirements. At QM Service Global, we provide structured guidance to help businesses transition smoothly, ensuring full compliance with UK regulations and uninterrupted market access.
UKCA Regulatory Strategy & Assessment
We conduct a comprehensive regulatory assessment to determine which UK regulations apply to your product category. Our team develops a tailored UKCA strategy that outlines documentation requirements, conformity assessment routes, and certification pathways specific to the UK market.
UK Responsible Person (UKRP) Representation
For manufacturers located outside the United Kingdom, appointing a UK Responsible Person (UKRP) is a legal requirement. We provide reliable UKRP services, ensuring proper representation, regulatory communication, and compliance oversight with UK authorities.
Documentation Alignment & MHRA Registration
We assist in adapting existing EU Technical Files to meet UK-specific requirements and support registration with the Medicines and Healthcare products Regulatory Agency (MHRA) for medical devices. This ensures full regulatory alignment and smooth entry into the UK market.
