Register medical devices to place on the market

AI Summary

This guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) outlines the mandatory registration requirements for medical devices and in vitro diagnostics (IVDs) placed on the Great Britain and Northern Ireland markets. Under the UK Medical Devices Regulations 2002 (UK MDR 2002), all devices—including custom-made and refurbished products—must be registered via the Device Online Registration System (DORS) before market entry. For manufacturers based outside the UK, the appointment of a single UK Responsible Person is required to handle registrations and regulatory obligations. The guidance highlights a critical prohibition against using the MHRA logo or claiming any form of official endorsement, accreditation, or approval, as registration is purely a regulatory requirement. Key compliance milestones include a new statutory fee structure effective April 1, 2026, and an annual fee payment deadline of July 31, 2026. Furthermore, significant transitions for the Northern Ireland market involve the use of the European Database on Medical Devices (EUDAMED) starting May 28, 2026. To maintain compliance, manufacturers must provide detailed technical documentation, Global Medical Device Nomenclature (GMDN) codes, and conformity assessments. Required actions include creating a DORS account, ensuring all registration data is accurate and frequently updated, and paying the necessary pro-rata or annual fees. Failure to update representative roles or settle outstanding fees may result in account suspension or closure by March 2026.