FOI release

Freedom of Information request (FOI 22/922)

Published 17 January 2024

11th October 2022

FOI 22/922

Dear

Thank you for your information request, dated 22nd August 2022, where you asked for the current status of applications for UK Approved Bodies for medical devices (as per UK MDR 2002 for medical devices, active implantable medical devices and IVDs), how many applications are in process, what stage of the process are they at and what designation codes have been applied for by each applicant.

I am pleased to provide you with some of the information requested, see below.

As of 10th October 2022:

• We designated DEKRA Certification UK Ltd as  new UK Approved Body on 1st September 2022. Information about the scope of their designation is available on our website: Medical devices: UK approved bodies - GOV.UK (www.gov.uk)
• We are currently processing six applications for designation as a UK Approved Body for medical devices
• We have undertaken a designation audit in relation to two of these applications and they are now in the post-audit phase. The other applications are in the initial review phase
• Each applicant has applied for a different combination of codes across the whole scope of medical devices, active implantable medical devices and in-vitro diagnostics.
• We have not received any applications for designation as a UK Notified Body for the purposes of UKNI marking.

Unfortunately, some of the information is exempt from release under section 43: the names of the organisations who have applied for designation and the specific codes that each applicant has applied for:

Section 43 – Commercial interests: information where disclosure would be likely to prejudice the commercial interests of any person, including third parties or the public authority that holds the information. Section 43 is a qualified exemption, which means that we have considered whether the public interest in releasing the information is outweighed by the public interest in not giving the information. In favour of disclosure, we consider that there is a general public benefit from providing reassurance that there is sufficient Approved Body capacity for medical devices.  However, we consider that the public interest will be better served by not releasing the information as the specific codes each organisation applies for is commercially sensitive for that organisation. We have indicated above that across the applications received thus far, the full range of codes have been applied for. The specific codes an organisation has been designated against will be published once they have been designated. Releasing the information would also prejudice the Agency’s commercial interests in this case and in future. As a market regulator, it is vital that the Agency can freely engage in dialogue with organisations about commercial activities.

The Freedom of Information Act only entitles you to access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For more information on the reproduction or re-use of MHRA information

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

If you have a query about the information provided, please reply to this email.

Yours sincerely

MHRA Customer Experience Centre