[Home](/)/[Resources](/resources)/UK Medical Devices Medical DevicesMHRA # UK Medical Devices Regulations: MHRA Registration Guide Medical devices placed on the Great Britain market must comply with the UK Medical Devices Regulations 2002 (as amended). This requires MHRA registration, appropriate conformity assessment, UKCA marking, and ongoing post-market surveillance. Copy Link[Share on WhatsApp](https://wa.me/?text=https%3A%2F%2Fkrono-labs.com%2Fguides%2Fuk-medical-devices-mhra) ## Medical device classification Class ILow risk Stethoscopes, bandages, surgical instruments Self-certified by manufacturer Class IIaLow-medium risk Hearing aids, ultrasound equipment Approved Body assessment Class IIbMedium-high risk Infusion pumps, CT scanners Approved Body assessment Class IIIHigh risk Pacemaker, heart valves, implantable devices Approved Body assessment ## Registration process 01 ### Determine device classification Use UK Medical Devices Regulations classification rules based on intended purpose, duration of use, and body contact characteristics. 02 ### Appoint UK Responsible Person (if foreign manufacturer) Manufacturers outside the UK must appoint a UK Responsible Person who takes responsibility for compliance and MHRA registration. 03 ### Conformity assessment Higher risk devices require Approved Body assessment. Class I devices can typically self-certify. Establish and maintain a quality management system. 04 ### MHRA registration Register the device with MHRA through the Devices Online Registration System (DORS). Pay registration fees and provide required device information. 05 ### UKCA marking and placement Affix UKCA marking to the device (or CE marking for Northern Ireland). Place on the GB market with appropriate instructions and labeling. ## Technical documentation requirements Medical device technical documentation must be comprehensive and demonstrate compliance with general safety and performance requirements. Required elements include: * Device description and specifications * Intended purpose and intended users * Labeling and instructions for use * Design and manufacturing information * Risk management file (ISO 14971) * Clinical evidence and evaluation * Post-market surveillance procedures * Quality management system documentation (ISO 13485) The UK Responsible Person (for foreign manufacturers) or the manufacturer (for UK-based) must maintain this documentation and make it available to MHRA upon request. ## Post-market surveillance and vigilance Medical device manufacturers must maintain post-market surveillance systems to actively and systematically gather, record, and analyze data on device quality, performance, and safety. This includes review of complaints, literature, and other relevant data sources. Serious incidents involving medical devices must be reported to MHRA through the vigilance system. Manufacturers must also report field safety corrective actions and cooperate with any investigations or recalls required. ## Learn this properly, not just for one product In-depth courses and books that teach the process β€” not a one-off answer you'll need to look up again next time. [Start the course β€” $149](/courses/09-ukca-marking-for-electronics-products)See your free roadmap [Prefer to read? Get the book β€” $24.99](/books/09-ukca-marking-for-electronics-products) ## Frequently asked questions ### Do all medical devices need MHRA registration? Yes, all medical devices intended for the Great Britain market must be registered with MHRA before being placed on the market. This includes Class I, IIa, IIb, and III devices, as well as IVDs and custom-made devices. ### Can I use CE marking for medical devices in the UK? In Great Britain, UKCA marking is required for medical devices. CE marking is not recognized for medical devices placed on the GB market after the transition period. In Northern Ireland, CE marking (or CE+UKNI) continues to apply. ### What is a UK Responsible Person for medical devices? Manufacturers outside the UK must appoint a UK Responsible Person (UKRP) who takes responsibility for regulatory compliance, maintains technical documentation, cooperates with authorities, and handles registration with MHRA. πŸ‡¬πŸ‡§ UK roadmap for your product Every standard, document, and test that applies β€” free, no account required. See your free roadmap[ Want an expert to take your product through πŸ‡¬πŸ‡§ UK compliance for you? One consultant from Krono's compliance team takes your product from requirements to legal sale, with a fixed quote before any work starts. See compliance services](/services) Learn this properly In-depth course that teaches the full process, not just this one answer. [Start the course β€” $149](/courses/09-ukca-marking-for-electronics-products)[Prefer to read? Get the book β€” $24.99](/books/09-ukca-marking-for-electronics-products) Related guides * [UKCA Marking OverviewComplete guide to UKCA marking for the Great Britain market: requirements, timeline, costs, GB vs NI differences, and how to tr…](/guides/ukca-marking) * [UK Responsible PersonComplete guide to UK Responsible Person requirements: when appointment is required, obligations by product category, and how to…](/guides/uk-responsible-person) * [UK Post-Market SurveillanceComplete guide to UK post-market surveillance requirements: monitoring, incident reporting, corrective actions, recalls, and on…](/guides/uk-post-market-surveillance) * [UK Market Compliance OverviewComplete guide to UK market compliance for foreign companies: regulatory framework, key obligations, and steps to enter the Gre…](/guides/uk-market-compliance-overview) * [UK Class IIa and IIb Medical DevicesClassifying, evidencing, and UKCA marking Class IIa and Class IIb medical devices under UK MDR 2002 as amended: clinical evaluation expectations, technical file structure, UK Approved Body involvement, and the post-Brexit regulatory split.](/guides/uk-medical-device-class-iia-iib) Educational resource only. Medical device compliance is complex and may require professional guidance. Always verify current MHRA requirements.