U.K. To Increase Regulatory Fees For Medtech Manufacturers, Notified Bodies
The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) has announced that it will move forward with its proposal to increase and/or add fees charged to medical device makers applying for regulatory approval for designations, audits, registrations, and clinical investigations. The fees are intended to offset regulatory costs, and will undergo regular audits to ensure they remain fair.
The proposed fees were first introduced last April in response to changes and additional regulatory workload instituted by the E.U., which had placed a financial strain on the agency, according to Regulatory Affairs Professionals Society (RAPS). The agency reported that regulatory funding for devices was half of its 2003 amount, and the fee structure had not been revised or increased since 2010.
“Funding for devices regulation is at half the level of what it was in 2003 in real times; and while a number of efficiency measure shave been taken, this is against a backdrop of adverse incident reporting which has more than doubled since 2007,” wrote the agency in its business plan, which reported that device regulation currently is subsidized by the U.K. Department of Health (DH), and the proposed fees would replace the majority of DH funding in this area.
The revised funding model, which was open for consultation from November to January, is intended to better address expenses incurred by E.U. regulations 920/2013 for reviewing active implantable medical devices and Commission Regulations that require re-designation audits for notified bodies (third parties that authorize the use of devices across the EU). These audits do not currently require payment of a fee, but will under the new model, according to RAPS.
Under the proposed model, device makers will see increased fees for registering class 1, custom, and IVD medical devices, and new fees will be imposed upon device developers seeking authorization for clinical trials. Overall, funding for MHRA will increase from approximately $300,691 to $576,697.
The MHRA received ten responses from stakeholders following its request for consultation, including two distributors, five manufacturers, and three trade associations representing a total of 555 members. A majority of responses indicated that the fees would cause very little, if any, impact to the medical device market in the U.K.
“The majority of respondents were content with the fee changes proposed,” said the agency in a recent report. The agency acknowledged concern over undue burden on business and stated that the 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 subsidize.”
Following the U.K.’s referendum vote to discontinue its membership from the European Union (E.U.), the MHRA is working to establish its future role. According to RAPS, the British Standards Institutions (BSI) has indicated that it will continue its role as an “EU Notified Body,” and the MHRA will work closely with the European Medicines Agency (EMA) to protect public health.