Warning to practices

Many practices may not realise that they should be registered with the Medicines Healthcare Products Regulatory Agency (MHRA) for the 'assembly' of spectacles.

The warning has come from the Optical Voucher Consultative Committee, which has stated that for optical practices assembly is the act of putting together lenses and frames to make complete spectacles.

Lenses and frames are viewed as medical devices under the EU Directive, so the works is within the MHRA's sphere of activity.

'This only applies to new products,' said a OVCC spokeswoman. 'For example, assembling new lenses into new frames. You do not have to register if you are only putting lenses into patients' existing frames.

Nor do you have to register if you are modifying frames or cutting lenses on the premises, since these activities are neither manufacture nor assembly.'

Failure to register constitutes a criminal offence and so the penalty for non-registration could be a criminal conviction or caution. In turn this could involve a GOC disciplinary case.