[Home](/)/[Resources](/resources)/UK IVD Devices In-Vitro DiagnosticsMHRA / UK IVDR # UK In-Vitro Diagnostic Devices: MHRA Registration and Classification Guide UK IVD regulations diverged from the EU IVDR regime after Brexit. Non-UK manufacturers need a UK Responsible Person, MHRA device registration, and for most IVDs, UK Approved Body involvement. EU IVDR CE certificates no longer automatically cover the GB market. Understanding the classification rules and the MHRA registration process is the first step for any IVD entering the UK. Copy Link[Share on WhatsApp](https://wa.me/?text=https%3A%2F%2Fkrono-labs.com%2Fguides%2Fuk-medical-devices-ivd) ## UK IVD classification (A, B, C, D) ### Class A **Examples:** General laboratory instruments, specimen receptacles, buffers, washing fluids, general purpose culture media **Approved Body:** Self-certification — no Approved Body involvement **MHRA registration:** MHRA registration required before placing on market ### Class B **Examples:** Self-testing devices for non-serious conditions, devices for blood glucose monitoring (Class B in UK IVDR) **Approved Body:** MHRA Approved Body involvement required for conformity assessment **MHRA registration:** MHRA registration required ### Class C **Examples:** Blood grouping reagents (ABO), HLA typing, HIV confirmatory testing, HCV, HTLV diagnosis **Approved Body:** UK Approved Body mandatory; design examination certificate required **MHRA registration:** MHRA registration required ### Class D (highest risk) **Examples:** HIV screening blood, hepatitis B surface antigen, Treponema pallidum (syphilis), blood group antigens beyond ABO **Approved Body:** UK Approved Body mandatory; performance evaluation review; MHRA oversight of certain devices **MHRA registration:** MHRA registration required; some devices need specific MHRA authorisation ## UK IVD registration process 01 ### Classify your IVD under UK IVDR class A, B, C, or D UK classification broadly mirrors EU IVDR (Regulation (EU) 2017/746) as retained and amended UK law. Class A is the lowest risk; Class D is the highest. Misclassification is a common error — review the classification rules in Annex VIII of the UK IVDR carefully. 02 ### Engage UK Approved Body (Classes B, C, D) For Class B, C, and D IVDs, you must engage a UK Approved Body notified under the UK IVDR. The UK MHRA maintains a register of UK Approved Bodies. EU Notified Bodies' EU IVDR certificates do not substitute for UK Approved Body assessment. 03 ### Prepare technical documentation and performance evaluation Technical documentation must include performance evaluation (analytical and clinical performance), risk management file, labelling, and manufacturing information. Performance evaluation follows EN 13612 and CLSI or equivalent standards. 04 ### Register with MHRA on the Device Registration System (DRS) All IVD manufacturers and UK Responsible Persons must register on MHRA's Device Registration System before placing on the GB market. Registration is separate from conformity assessment — both are required. 05 ### Issue UK Declaration of Conformity Sign a UK Declaration of Conformity referencing UK IVDR essential requirements met. Retain with technical documentation for the required post-market period. ## Learn this properly, not just for one product In-depth courses and books that teach the process — not a one-off answer you'll need to look up again next time. [Start the course — $149](/courses/09-ukca-marking-for-electronics-products)See your free roadmap [Prefer to read? Get the book — $24.99](/books/09-ukca-marking-for-electronics-products) ## Frequently asked questions ### Do EU MDR/IVDR CE certificates work for the UK (Great Britain) market? No longer on their own. Since July 2023, CE-marked medical devices and IVDs under the EU MDR/IVDR are not automatically accepted in Great Britain. Non-UK manufacturers must have a UK Responsible Person registered with MHRA, register devices on the MHRA Device Registration System, and for Classes B–D IVDs, must have UK Approved Body involvement. Devices with legacy EU MDD/IVDD CE certificates have had a transitional acceptance period — always verify current MHRA guidance for your specific device and certificate type. ### What is a UK Responsible Person for IVDs? A UK Responsible Person (UKRP) is an entity established in the UK that takes on responsibility for regulatory compliance on behalf of non-UK IVD manufacturers placing devices on the GB market. The UKRP must be registered with MHRA, must maintain registration on the DRS for the devices they cover, and must be the point of contact for MHRA regulatory actions. The UKRP role is similar to the EU Authorised Representative but is a UK-specific legal obligation with specific MHRA registration requirements. ### What is the performance evaluation requirement for UK IVDs? Performance evaluation for UK IVDs must demonstrate analytical performance (sensitivity, specificity, accuracy, repeatability, reproducibility, limits of detection) and, for higher-risk classes, clinical performance (diagnostic sensitivity, diagnostic specificity, positive and negative predictive values, ROC curves). Performance evaluation must be based on studies using UK/EU reference materials or materials traceable to international standards. The performance evaluation is a living document updated throughout the device's lifecycle. 🇬🇧 UK roadmap for your product Every standard, document, and test that applies — free, no account required. See your free roadmap[ Want an expert to take your product through 🇬🇧 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 — $149](/courses/09-ukca-marking-for-electronics-products)[Prefer to read? Get the book — $24.99](/books/09-ukca-marking-for-electronics-products) Related guides * [Software as a Medical Device (SaMD) UKComplete guide to Software as a Medical Device (SaMD) in the UK: MHRA classification framework, when software qualifies as a me…](/guides/uk-software-medical-device) * [UK Medical Device Clinical EvaluationComplete guide to UK medical device clinical evaluation requirements under MHRA regulations: what clinical evaluation must demo…](/guides/uk-medical-device-clinical-evaluation) * [UK Approved Body vs EU Notified BodyComplete guide to UK Approved Bodies vs EU Notified Bodies: what changed after Brexit, which products require third-party asses…](/guides/uk-approved-body-vs-notified-body) * [CE to UKCA Transition GuideStep-by-step guide to transitioning from CE marking to UKCA marking for the Great Britain market: what changes, what stays the …](/guides/ce-to-ukca-transition) * [Selling to the UK from the EU After BrexitComplete guide for EU-based companies selling to the UK after Brexit: customs duty and import VAT, UK product safety compliance…](/guides/uk-selling-from-eu) Educational resource only. Always verify current MHRA guidance for your device classification and registration requirements before placing IVDs on the GB market.