Regulating Medical Devices in the UK to Place on the Market

Overview of the Regulatory Framework The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medical devices in the UK, including in vitro diagnostic devices (IVDs) and active implantable devices. The framework differs between Great Britain (England, Wales, Scotland) and Northern Ireland due to the Northern Ireland Protocol. In Great Britain, devices conform to the Medical Devices Regulations 2002 (UK MDR 2002, as amended), implementing EU directives (MDD, AIMDD, IVDD) with transitional acceptance of CE marking. Northern Ireland applies EU MDR (2017/745) since 26 May 2021 and EU IVDR (2017/746) since 26 May 2022. Medical devices are defined broadly, excluding other CE/UKCA products. Professional advice is recommended if classification is unclear. Source: Regulating medical devices in the UK - GOV.UK (last updated 17 February 2025) Key Requirements for Placing Devices on the Great Britain Market Since 1 January 2021, devices must conform to UK MDR 2002. UKCA marking applies for new assessments by UK approved bodies, but CE marking from EU directives/notified bodies is accepted under extended transitional periods:

EU MDD/AIMDD-compliant devices: until certificate expiry or 30 June 2028 (whichever sooner). EU IVDD-compliant devices: until certificate expiry or 30 June 2030. EU MDR/IVDR-compliant devices: until 30 June 2030.

All devices (including IVDs, custom-made, systems/procedure packs) must be registered with the MHRA before placement. Non-UK manufacturers appoint a UK Responsible Person. Self-declaration allowed for non-sterile/non-measuring Class I and general IVDs; third-party assessment required otherwise. Source: Regulating medical devices in the UK - GOV.UK UKCA Marking and Conformity Assessment UKCA marking is for Great Britain only (not recognised in EU/NI). It requires conformity assessment per UK MDR 2002 (modified EU directives). UK approved bodies (designated by MHRA) perform third-party assessments. Former UK notified bodies transitioned to approved bodies. For CE marking, valid certificates from EU notified bodies are recognised in GB during transitions. Both UKCA and CE can appear if compliant. Source: Medical devices: conformity assessment and the UKCA mark Responsibilities of Manufacturers and Supply Chain Manufacturers ensure conformity, technical documentation, labelling (including UK Responsible Person details for UKCA), and post-market surveillance. Non-UK manufacturers appoint a UK Responsible Person (written authority required) to handle registration, documentation, MHRA cooperation, and complaints. Importers/distributors inform the manufacturer/Responsible Person and provide details to MHRA if needed. All must cooperate on corrective actions. Source: Regulating medical devices in the UK - GOV.UK Registration Requirements Registration via Device Online Registration System (DORS) is mandatory before GB market placement. Fee applies (updated periodically). NI-registered devices can access GB without re-registration (unfettered access). Source: Register medical devices to place on the market Post-Market Surveillance and Vigilance Manufacturers monitor performance, report incidents, and implement field safety actions. The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 strengthen requirements (effective 16 June 2025), enhancing traceability, risk management, and swift MHRA action. Guidance supports implementation across device types. Source: First major overhaul of medical device regulation comes into force across Great Britain (16 June 2025) Regulation in Northern Ireland CE marking required (UKNI optional if UK body used, but none designated). Manufacturers appoint EU/NI Authorised Representative. Certain devices/IVDs/custom-made register with MHRA. EU notified bodies mandatory for third-party assessment. Source: Medical devices: EU regulations for MDR and IVDR Future Reforms and Roadmap The MHRA pursues phased reforms prioritising safety, access, and innovation. Post-market surveillance updated in 2024/2025; pre-market changes (e.g., routes to market, IVDs, international reliance) planned via statutory instruments in 2025-2026. Roadmaps and consultations guide timelines. Source: Implementation of the future regulations (updated 15 December 2025) This guidance reflects the framework as of early 2026, with ongoing reforms. Always consult the official GOV.UK page for updates.