The Statement of Manufacture:
A signature to go with every appliance supplied by a Laboratory that says it has been manufactured to the standards and guidelines set out by the MHRA.
– Who can sign it?
In 2008 statutory registration was forced upon Dental Technicians by, and overseen by, the General Dental Council.
A good idea in a couple of areas maybe, for example keeping any ‘cowboys’ out of the trade or at least making them ‘come up to scratch.’ Part of this entails ‘Continuing professional development’ by spending our own time and money on often meaningless hours of study to be able to stay registered.
So at the very least this should mean something, something like giving the signing of the SoM some worth. Not necessarily according to the GDC or the MHRA.
So then I read the next three paragraphs in the July issue of ‘The Dental Technician’
A Dental Technician (not me though I wish I had thought of it) has asked the GDC and the MHRA if there are any restrictions as to who can sign the SoM.
The MHRA said “In terms of the Medical Devices Directives (93/42/EEC), there’s no specific stipulation that the statement of manufacture must be signed off by someone suitably qualified or by a GDC registrant”
The GDC was asked “If there is any legal bar that they are aware of that prevents anyone from signing the SoM? The GDC replied “This is a legal matter on which the GDC cannot advise. You may wish to seek legal advice on this matter”
So even work from abroad, (some good, some bad) does not have to be checked by, adjusted if necessary, and signed off by a Technician who would be struck off if not registered with the GDC and signed up with the MHRA. The same GDC by the way who are proactive in hunting down any Technician for the slightest misdemeanour and fining or banning them.
The GDC is an Ass.
Until next time…….