UK MHRA IVD Registration Service
UK market-access support for IVD products, combining the source List A/List B and General/Self-test workflows into one product. EXIMIO can assist with classification, conformity-route planning, technical documentation and MHRA-related registration coordination.
Choose an option
Service Overview
The source workbook separates higher-risk legacy List A/List B routes from General and Self-test IVD routes. For Shopify, these are better presented as variants of one UK MHRA IVD registration product, with the final conformity and registration route confirmed against the rules applicable to the device at the time of the project.
Process Flow & Timing
Select a route below to view the workflow and timing.
Higher-Risk IVD (Source: List A / List B)
Indicative source timeline~12 monthsSource estimate; not statutory
MHRA Registration — Source List A / List B
List A IVD
List B IVD
Full Quality-Assurance System
Product Design-Dossier Review
Finished-Product Verification
UK Approved Body Review
Full Quality-Assurance System
EC Sample Examination / Product QA
UK Approved Body Review
UKCA Certification
General / Self-test IVD
Indicative source timeline~11 monthsSource estimate; not statutory
MHRA Registration — General / Self-Test IVD
General IVD
Self-Test IVD
Conformity Declaration
UKCA Certification
Full QA System
EC Sample Examination
Conformity Declaration
UK Approved Body Review
EC Verification / Production QA
Product Design Review
UK Approved Body Review
UK Approved Body Review
UKCA Certification
UKCA Certification
UKCA Certification
Regulatory Basis & Official References
Legal and regulatory references below link directly to the relevant government regulator, official legislation database or official legal text. The applicable provisions should still be confirmed against the device classification, intended purpose and market-access route at project start.
LawUK Medical Devices Regulations 2002 (SI 2002/618)Current official legislation record for the UK medical-device framework.Open official source ↗LawUK MDR 2002 — Part IV (IVDs)Direct official Part IV provisions for in vitro diagnostic medical devices.Open official source ↗Official GuidanceMHRA — Register medical devices to place on the marketCurrent Great Britain registration requirements, including IVDs; last updated July 2026.Open official source ↗Official GuidanceMHRA — Regulating medical devices in the UKCurrent overview of GB, Northern Ireland, UKCA and CE transition arrangements.Open official source ↗Official GuidanceMHRA — IVD legislation guidanceOfficial guidance on legal routes for in vitro diagnostic medical devices.Open official source ↗
Related Regulatory Support
UK Responsible Person coordination, technical-document review, QMS preparation and conformity-assessment support can be included in project scope where applicable.
EXIMIO Support
Contact EXIMIO BIOTEC for pathway confirmation, document-gap review, submission planning, technical-document preparation, authority communication support and a project-specific quotation.