Consultation outcome

Proposal on increases and additions to current medical devices fees

This consultation has concluded

Download the full outcome

Government response to the consultation on increases and additions to current medical devices fees

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Detail of outcome

The majority of respondents were content with the fee changes proposed. We have noted the concerns over increasing costs and to minimise the burden on businesses MHRA will review its fees regularly to ensure they are set as low as possible, whilst still covering the cost to MHRA of regulation. This approach is intended to make sure that the government neither profits at the expense of consumers or industry, nor makes a loss for taxpayers to subsidise.

Original consultation

Summary

We are seeking views on amending fees for the regulation of medical devices. Please tell us what you think.

This consultation ran from
to

Consultation description

MHRA already charges fees for:

  • auditing and designating notified bodies
  • registering class 1 medical devices, custom made devices and in vitro diagnostic medical devices
  • clinical investigations

We want to know what you think

  • The fees for auditing notified bodies have not increased since 2010. They neither cover the full audit cost nor the cost of audit preparation work. There is also no fee in place in the UK for the re-designation audits of Notified Bodies.

  • The fees for the registration of class 1 medical devices, custom made devices and in vitro diagnostic medical devices have not increased since 2010 and do not cover the full cost.

  • Fees are charged for authorising clinical investigations, but not for the amendment of studies after they have been submitted, which is generating additional work.

The shortfall is being subsidised by the Department of Health therefore we are proposing to increase our fees to cover this.

It is proposed that the new fees will come into force during the financial year commencing April 2017.

Documents

Consultation document

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Regulatory Triage Assessment

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Published 24 November 2016
Last updated 6 February 2017 + show all updates
  1. Consultation outcome published
  2. First published.