Registration with the MHRA
Many practices may not realise that they should be registered with the Medicines Healthcare Products Regulatory Agency (MHRA) for “assembly” of spectacles. 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, which is why they come into the MHRA’s sphere of activity. This requirement only applies to new products, i.e. assembling new lenses into new frames. New frames and lenses must be CE marked. For further details, visit the MHRA website.You do not have to register if you are only putting lenses into patients’ existing frames.
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, so it is a serious matter.
Registration for assembly is by completion of a simple form and payment of a one-off fee of £70. The MHRA form covers manufacturers as well as assemblers, so we have adapted their form to show which sections assemblers should complete. The sections that are not necessary have been greyed out, and the correct code has been included. The form can be downloaded by clicking on the pdf document on the right hand side of this page.
If you are an "assembler" then you must keep a written "declaration of conformity" on the practice (see pdf document below).
