MHRA Medical Device Registration

The following is the information requested by the MHRA for medical device registration:

Manufacturer (Facility) Information:

  • Legal manufacturer Name, Address and contact information as per device primary information panel / Labels /packaging
  • Activity carried out by the legal manufacturer.
  • Person responsible to communicate with MHRA (Name, Email & Contact Information)
  • Mutually signed agreement with legal manufacturer and UK Responsible person.

Medical Device Information:

  • Applicable Regulation
  • Device Risk Classification
  • GMDN Code applicable to the device in scope
  • Basic UDI-DI ( Presently not enforced, but soon will come into effect)
  • Medical device brand/trade or proprietary name
  • Device model or versions
  • IFU / User Manual / Catalogue reference number
  • UK Approved Body Or Notified Body name and address for all classes other than class I
  • Type of Sterilization (If applicable)
  • Details about Latex and phthalates.
  • Medical Device MRI compatibility issues
  • conformity assessment certificates
  • Signed and dated Declaration of Conformity
  • Technical File latest revision number with date.

To know more, please contact us