UK’s MHRA Proposes New Medical Device Fees

February 17, 2017

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) plans to raise its licensing and other fees for medical device manufacturers and notified bodies to help make up a chronic funding shortfall.

Most of the new fees will come from notified bodies to cover designation, auditing, and related activities. However, manufacturers’ fees for registering Class I devices, custom-made devices, and in vitro diagnostics also will increase from £70 to £100 ($87-$125).

The MHRA receives about 620 device registrations and 360 registration change requests annually.

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