UK USER FEES FOR MEDICAL DEVICES SET TO RISE IN 2007

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has published a consultation paper seeking comment on a proposed hike in industry fees for medical device regulatory activities.

Slated to take effect April 1, 2007, it would be the first increase in device-related user fees in 10 years, the MHRA said.

Total fees are projected to raise about $97,450, from approximately $477,506 to about $574,956, the agency said. Of that amount, about $58,470 is anticipated from increased fees related to clinical trial activities and about $38,980 will derive from activities associated with notified bodies.

The MHRA is required by law to recover all costs for relevant medical device regulatory activities. According to the agency, it has been "carrying these additional cost pressures within our overall financial position for some time" and can no longer do so without raising fees or cutting services.

Not all fees are set to increase. The current registration fee of about $136 will remain the same. The MHRA is proposing to increase fees for Class I, Ixia and Ibis medical devices that are neither implantable nor long-term invasive from about $4,288 to about $5,262. Fees for Class Ibis implantable or long-term invasive, Class III and active implantable medical devices would increase to about $7,406 from the present $5,847.

Comments on the proposal are due Feb. 13.

To view the MHRA document, go to www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&ssDocName=CON2025302&ssSourceNodeId=387&ssTargetNodeId=372 (http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&ssDocName=CON2025302&ssSourceNodeId=387&ssTargetNodeId=372).