FOI release

Freedom of Information request on medical devices in use - csv format including Supplier ; Manufacturers ; Product code ; Product description ; GTIN; Unit of Issue; Brand ; E Class and Category (FOI 22/477)

Published 1 June 2022

FOI 22/477

18th March 2022

Dear

Thank you for your communication to the MHRA in relation to a Freedom of Information request for:

“Item information request for medical devices in use - csv format including

Supplier

Manufacturers product code

Product description

GTIN

Unit of Issue

Brand

EClass

Category

Volumetric Information (if applicable) UOI per case, Cases per layer, layers per pallet)

I am not requesting or requiring volumes or spend information - just product detail of medical

product/devices approved for use”

The MHRA publish data of registered medical devices on the Public Access Registration Database (PARD) which includes:

  • Manufacturer name and address
  • UK Responsible Person or Northern Ireland Authorised Representative name and address, if applicable.
  • Date registered
  • Account number
  • Device by GMDN Term or generic MHRA Term

If you have a query about this letter, please do not hesitate to contact us at

If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please email: info@mhra.gov.uk

Due to the ongoing Covid-19 pandemic, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices.

After that, if you remain dissatisfied, you may write to the Information Commissioner at;

The Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

They will make a decision on whether or not we have interpreted the FOIA correctly in handling your request.

Yours sincerely

MHRA Customer Experience Centre

Communications and engagement team

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU Telephone 020 3080 6000