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