MHRA to Increase Charges to Medical Device Makers
by Barbara Kram, Editor | March 13, 2007
Increases take effect April 1, 2007
The Medical and Healthcare Products Regulatory Agency (MHRA) has now completed its consultation regarding a proposed increase in the fees that it charges to the medical devices industry and notified bodies for some of its medical device regulatory activities. This followed a rigorous costing exercise with increases being targeted to reflect actual costs.
The Consultation
The consultation commenced on 21 November 2006 and closed on the 13 February 2007. 79 consultation letters were sent out to some of our external stakeholders, including trade associations, medical device manufacturers and UK Notified Bodies.
Out of the 79, 4 responses were received; 3 had no comments, or accepted the proposed increase to fees; whilst 1 of the respondees was fundamentally opposed to the increase.
All copies of the replies can be found from the consultations page or obtained, via e-mail, from Ms Angela Bartley (angela.bartley(at)mhra.gsi.gov.uk)
Ministers, having considered carefully all of the comments made in response to the consultation exercise, have decided to proceed with the implementation of these increase to fees, and the Regulations (The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007 - Statutory Instrument 2007 No. 610) were laid before Parliament on 7 March to come into force on 1st April 2007. They can be found at : "Statutory Instrument 2007 No. 610"
The new scale of fees from 1st April 2007, subject to parliamentary approval, and more details, can be found at: "Proposed increase to medical devices fees"
The Consultation
The consultation commenced on 21 November 2006 and closed on the 13 February 2007. 79 consultation letters were sent out to some of our external stakeholders, including trade associations, medical device manufacturers and UK Notified Bodies.
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Out of the 79, 4 responses were received; 3 had no comments, or accepted the proposed increase to fees; whilst 1 of the respondees was fundamentally opposed to the increase.
All copies of the replies can be found from the consultations page or obtained, via e-mail, from Ms Angela Bartley (angela.bartley(at)mhra.gsi.gov.uk)
Ministers, having considered carefully all of the comments made in response to the consultation exercise, have decided to proceed with the implementation of these increase to fees, and the Regulations (The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007 - Statutory Instrument 2007 No. 610) were laid before Parliament on 7 March to come into force on 1st April 2007. They can be found at : "Statutory Instrument 2007 No. 610"
The new scale of fees from 1st April 2007, subject to parliamentary approval, and more details, can be found at: "Proposed increase to medical devices fees"
