Posted 06 February 2017
By Michael Mezher
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Monday said it will move ahead with a proposal to increase and add to the fees it charges device makers and notified bodies.
While the agency noted some concerns over the increased costs associated with the fees, it said that the "majority of respondents were content with the fee changes proposed."
Last April, MHRA released its business plan for 2016-2017, warning of serious financial troubles for the agency due in part to declining funding for regulating medical devices.
"Funding for devices regulation is at half the level of what it was in 2003 in real terms; and while a number of efficiency measures have been taken, this is against a backdrop of adverse incident reporting, which has more than doubled since 2007," MHRA said.
MHRA also notes that the fees it currently charges have not increased since 2010, and do not cover the cost of the agency's workload pertaining to each fee. Presently, MHRA says this shortfall is being made up by the Department of Health.
Additionally, MHRA says that recent regulations, including the Commission Implementing Regulation (EU) No. 920/2013 and Commission Recommendation 2013/437/EU have increased the agency's workload and introduced the requirement for re-designation audits for notified bodies.
In an effort to better balance its books, MHRA proposed to increase existing fees for medical device manufacturers and notified bodies, as well as to add a host of new fees for re-designating and auditing notified bodies and reviewing amendments to clinical investigations.
In total, the agency expects to roughly double its income from device-related fees from £241,000 to £462,000 annually.
The majority of the income from the new fees is expected to come from notified bodies, who MHRA says will pay £161,000 more in fees than they have under the current scheme.
For device makers, the agency is increasing its fee to register low-risk (Class 1) and custom medical devices, as well as in vitro diagnostics from £70 to £100. MHRA says it receives around 620 registrations and 360 amendments from device makers each year, and expects the fee increase to bring in nearly £30,000 in additional income.
According to the proposal, the new fees are expected to take effect in April 2017 and will be reviewed by the agency on an annual basis.
MHRA – Response to Consultation
MHRA – Consultation