Posts Tagged ‘MHRA’
Updated clinical trials guidance document issued by MHRA
The MHRA has recently issued updated guidance on clinical investigations to be carried out in the UK. It’s an update on previously available guidance that takes into account the impact of 2007/47/EC, the revision to the directives which takes effect in March 2010. One of the major updates in this document is the confirmation that it will be much more difficult to obtain regulatory approval using only clinical literature and that more products will require a clinical investigation.
In addition the guidance talks the reader through making an application, outlines how it will be processed and what documentation will be required.Download here mhra-guidance-re-clinical-investigations-july-2009
For guidance as to whether your product will require a clinical investigation please contact Danielle.avadis@mediqol.com
Drug or Device? – MHRA issues updated guidance on borderline cases
Directive Bulletin 17 provides updated guidance on the regulatory criteria for considering drug/device borderline products. It also contains a very useful appendix that lists a number of products and clarify’s their classification depending on intended use or mode of action.
MHRA fee increases
The MHRA has confirmed that it has increased the fees it charges notified bodies and medical device manufacturers with effect from 1 April 2009. The increases reflect the increased amount of resources that are being allocated by agency staff to this activities. You can find a document outlining the new fees here.
