Originally Published IVD Technology November/December 2003
IVD DIRECTIVE
Current Topics in the UK|
Return
to Article: |
The laboratories in the UK exhibit three particular characteristics that are not found elsewhere in Europe. First, there is a plethora of different professional bodies whose members are inclined toward scientific endeavor and manipulating commercial products. Second, the funding system is not based on reimbursement for getting a test done, but rather as overhead on secondary care with consequent yearly budget reductions. And third, the human resource policies cause terminal difficulties in recruiting and retaining staff. The resulting inward-looking culture driven by these characteristics might explain why the IVD Directive has only recently appeared above the horizon in UK clinical laboratories. The following are some examples of how the directive has affected the IVD industry in the UK.
- The UK competent authority, the Medicines and Healthcare Products Regulatory Agency (MHRA), has issued a guidance to the National Health Service (NHS) on how the directive will affect its in-house activities. For example, from December 2003, NHS laboratories will be required to obtain a CE mark for any reagents and assays that they supply to other legal entities, whether invoiced or free of charge.
- Pathology laboratories providing testing services can continue to do so without getting a CE mark until December 2005, since MHRA has interpreted these services as being already placed on the market. It is possible that the British IVD industry may dispute this as an unfair advantage.
- The UK may be in danger of losing the ability to have true open systems available on the market. There seems to be a requirement from MHRA to have every reagent kit on the market validated for every instrument platform available. MHRA is currently preparing a guidance on this matter that it will share with the other competent authorities. It is not yet clear if this will be an isolated issue to the UK or a pan-European issue.
Copyright ©2003 IVD Technology
