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MHRA Registration

A requirement for manufacturers placing medical devices or IVDs on the Great Britain market, managed by the MHRA.
I need MHRA registration
  • Medical Devices & IVDs, UK Market

What are MHRA Registration services

Fixed Project Fee
Cyberpan Support Services Ltd

The Medicines and Healthcare products Regulatory Agency (MHRA) requires manufacturers and their UK Responsible Persons to register medical devices and IVDs placed on the Great Britain market. Registration must be completed before placing devices on the market, and records must be kept current as products, labelling, or compliance status changes.

We manage MHRA device listing and registration maintenance — either as part of a UKRP appointment or as a standalone service for manufacturers who already have a UKRP in place and need registration support only.

Fixed project fee. All submissions documented and traceable.

What we do

  • Register and list medical devices and IVDs with the MHRA
  • Maintain device registration records as products, labelling, or compliance status changes
  • Submit serious incident and field safety corrective action (FSCA) notifications to the MHRA
  • Manage post-market surveillance documentation to MHRA expectations
  • Provide confirmation of registration status as required for importer or distributor records

Who needs this?

  • Manufacturers placing medical devices or IVDs on the Great Britain market for the first time
  • Manufacturers with outdated, incomplete, or incorrectly structured MHRA device records
  • Companies that have a UKRP in place but need dedicated registration management support
  • Manufacturers whose device range has expanded and whose existing registration records need updating

What you'll receive

MHRA device listing confirmed. A maintained registration record with a documented submission log. Confirmation of compliance status suitable for sharing with UK importers and distributors.
I need MHRA registration
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