MHRA Medical Device Registration & DORS Readiness
MHRA registration is required before applicable medical devices and IVDs are placed on the Great Britain market. Registration should be the final expression of an already-established regulatory pathway—not the point at which classification, certification or manufacturer data issues are discovered.
12 Core MHRA Registration Services
What We Review Before Registration Filing
MHRA Registration Readiness — Established Before Filing
Before the device is entered into DORS, the manufacturer should demonstrate a coherent regulatory basis. The registration dataset must be traceable to the product's certification, legal manufacturer records and labeling.
Quality-Checking the Dataset Against Evidence
We quality-check the registration dataset against the underlying regulatory evidence before submission. Inconsistent legal manufacturer details, device attributes, classification, certificate information or UKRP data can create avoidable regulatory problems later, particularly during authority correspondence, vigilance or change management.
DORS Statutory Fee
MHRA introduced an updated device-registration fee structure, including an annual fee, from 1 April 2026. We check the applicable charges and registration scope against the current published guidance before filing. Check current MHRA fees.
Register with MHRA
Have our regulatory team verify your technical data and submit your DORS registration.
Start MHRA RegistrationComplete Your MHRA Medical Device & IVD Registration with Total Confidence
Our regulatory informatics specialists verify your DORS dataset and secure your official MHRA public register listing.