MHRA Publishes Response to Consultation on Increases to Medical Devices Fees
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The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published a response to a consultation on increases and additions to fees charged in relation to medical devices. The MHRA’s concluded that the majority of respondents were content with the fee changes and that it will review its fees regularly to ensure that they are set as low as possible whilst still covering the cost of regulation.
The MHRA had proposed in its consultation increases in its fees in order to collect an additional GBP 221,000 annually in order to reduce a shortfall in its fees that was being subsidised by the Department of Health. The MHRA proposed that fees paid both by Notified Bodies and medical device manufactures be increased or introduced. New fees were proposed in relation to re-designation applications for notified bodies and for amendments to studies carried out as part of clinical investigations of medical devices. The proposal was that the new fees would come into force during the financial year in April 2017.
In the response to the consultation the MHRA recorded that six out of seven respondents to the consultation agreed that the proposed new fees would not change the supply of, or demand for medical devices. Three respondents commented that the increases were fair whilst two respondents were concerned that the Notified Bodies would pass on the fee increases to medical device manufacturers. The respondents comprised medical device distributors, manufacturers and trade associations covering 555 members.