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 and includes lenses edged remotely. 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 RG2 and payment of a one-off fee of £70. A part completed RG2 can be downloaded from the link at the bottom of this page. 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).
MHRA Medical Devices Alert Response Form - January 2009
We have received reports that some PCTs have been sending optical contractors copies of the recent MHRA Medical Devices Alert response form and asking them to complete and return by 31 January 2009.
These are for PCTS to complete and return – not contractors. If you receive such a request, our advice is that you should simply ignore it. However, if you wish to reply, we suggest the following:
“Thank you for your email/letter of [DATE]. On the advice of the optical representative bodies, we do not believe these returns are intended for optical contractors. However, we confirm that we fully comply with the MHRA requirements under both our GOS contract(s) and MHRA legislation.
We hope this is helpful.”
We would request that if you receive one of these forms that you inform your representative body and LOC (who will in turn inform the LOCSU) for the purposes of monitoring.
