MDAÕs statement on reglazing of patientsÕ frames

ÔThis is the current position as to the regulatory status of spectacle frames at the end of the transitional period.
ÔAfter the end of the additional Transitional Period June 30 2001:
u The Medical Devices Directive does not cover the situation where a glazing shop is asked to put lenses based on an existing or new prescription into a patientÕs own frames which are not CE marked. This is because the frames are already legally owned by the customer and there is no change to ownership. This scenario also applies if the frames are already CE marked.
u The Medical Devices Directive does not allow an optician to sell after June 30 2001 a non-CE marked frame, which could subsequently be sent to a glazing shop to have lenses fitted.
ÔThe MDA anticipates no change in enforcement activity as a consequence of the expiry of the transition period.
ÔUnder the Medical Devices Directive glazing shops are required to register with their respective regulatory authority as assemblers/manufacturers of medical devices. In the UK 1,212 glazing shops have registered as assemblers under the Medical Devices Directive. If a glazing shop wishes to register then it should obtain a registration pack from the Agency.Õ