The fees for medtech clinical investigation notifications in the UK could rise from I April 2013 if a proposal by the Medicines and Healthcare products Regulatory Agency is finalised.Specifically, the MHRA has proposed to increase the fees for clinical investigation notifications of Class lib implantable or long-term invasive devices, Class III devices and active implantable devices from ￡4,240 (6,798) to 5,040. For Class I, lla and other lib devices the agency wants to increase the fees from 3,020 to 3,820.The MHRA says the fee hike is needed because it is having to put more resources into the review of clinical investigation notifications due to the increasing complexity of devices being submitted in these applications, particularly in the areas of software and biological safety.The increase, it says, is needed to ensure full cost recovery of its activities.As per the MHRA's proposal, the overall fee income required to cover this cost is likely to increase from about 351,000 to around ￡403,000; an increase of about ￡52,000.The new fee rates, if finalised, will come into effect on I April 2013, while all other regulatory fees (ie for notified body activity and registration) will remain the same.The MHRA has published its proposals for formal stakeholder consultation and will accept comments until 30 November
展开▼
