Hi
This may be a really dumb question - apologies.. I'm very new to the MDR.
Scenario:
If a qualified physiotherapist within an NHS community physiotherapy department supplied a simple elastic resistance band to a patient for the purposes of treatment / rehabilitation, should this activity be controlled within a Quality Management System / does it fit within the scope of 2017/745? Obviously the department would need to purchase bands that had a CE mark / the manufacturers had met their expectations with regard to the device, but does this duty extend to health services in 'putting into service' such 'devices'?
Thanks
James
This may be a really dumb question - apologies.. I'm very new to the MDR.
Scenario:
If a qualified physiotherapist within an NHS community physiotherapy department supplied a simple elastic resistance band to a patient for the purposes of treatment / rehabilitation, should this activity be controlled within a Quality Management System / does it fit within the scope of 2017/745? Obviously the department would need to purchase bands that had a CE mark / the manufacturers had met their expectations with regard to the device, but does this duty extend to health services in 'putting into service' such 'devices'?
Thanks
James