3 docs tagged with "guidance"

Index of MHRA guidance documents for medical devices, organised by topic — covering classification, clinical evaluation, post-market surveillance, vigilance, software, IVDs, and the MHRA Submissions portal.

Key forms, fee schedules, and timeline guidance for MHRA processes — registration fees, pre-submission meeting fees, export certificate fees, and indicative UKAB certification timelines.

A practical guide to using the MHRA Submissions portal for device registration, UKRP registration, vigilance reporting, and FSCA notifications — who needs an account, how to set one up, and what the portal is used for.