The MHRA is seeking feedback from interested parties on its proposal for increasing and addition of fees in its medical devices activities.
Currently, the MHRA charges fees for auditing and designating notified bodies, registering class I medical devices and authorising clinical investigations with medical devices.
The current fees have not increased since 2010 despite the increased workload generated by some changes in the regulation for notified bodies surveillance. Currently, the collected fees do not recover MHRA’s cost for these services. The shortfall is being subsidised by the Department of Health.
In order to transfer the cost from tax payer to the device industry, the MHRA proposes:
• To increase fees for designation and audit of the UK notifies bodies.
• To add new fees for the re-designation of the UK notified bodies.
• To increase fees for the registration of class I medical devices and change requests.
• To add new fees for the amendments of clinical investigation studies.
It is proposed that the new fees will come into force in April 2017.
For the calculation of this new fees, the MHRA made the assumptions that:
• The increase of fees will not impact the supply or demand for medical devices
• There are no additional administration cost, as all businesses affected already pay fees
• The fees will be reviewed annually to include the impact of new medical device regulation and UK’s relationship with the European Union.
The MHRA is interested to have the opinion of the interested parties on the new fees and on the assumption they made, particularly from the perspective of small and micro businesses.
The consultation is open until 13th January 2017. Click here to access the document.