Product Registration Services

UK Responsible Person (UKRP)

If you’re a medical device or IVD manufacturer without a registered office in the UK, you’ll need to appoint a local representative — your UK Responsible Person (UKRP) — before placing a product on the market.

Your UKRP manages your device registration, oversees relevant importer relationships, and liaises with the MHRA on your behalf. 

Prior to registration, a comprehensive review of your technical documentation and labelling against UK MDR requirements will be conducted, identifying any gaps and areas for improvement, ensuring your products are compliant and your UK market access is clear and straightforward. 

UK & EU Product Registrations

Regs by Karen Ltd provides hands-on support with product registrations. This includes MHRA DORS registrations for UK market access—ensuring your devices are correctly listed under the roles of UKRP or manufacturer— as well as navigating the evolving obligations within the EUDAMED database for EU market entry.

Services offered cover the full lifecycle of registration activities, from verifying device classifications to collating the required documentation, maintaining listings, and ongoing compliance as regulatory systems update.  Helping to keep your registrations and any updates accurate, timely, and aligned with both UK and EU expectations.

Cosmetics & General Product Compliance

Demonstrating that your cosmetics and general products meet UK and EU regulatory requirements is key to building trust and maintaining market access.

Regs by Karen Ltd provides expert guidance on UK and EU regulations, including product information files (PIFs), Technical Documentation, labelling and Responsible Person obligations.

Offering practical assistance to help you bring compliant products to market — giving you confidence that every detail meets the necessary standards.