Requirements for optical practices to register with the MHRA

November 18, 2021
Over recent years there has been some confusion related to the UK Medical Devices Regulations 2002, in particular the requirement for optical practices who assemble spectacles or surface lenses to register with the MHRA. This confusion seems to have been compounded by the UK leaving the EU, the current MHRA consultation on the future regulation of medical devices, and changes to the MHRA website.
However, at present medical device regulations in the UK are unchanged. Spectacle lenses and frames are still classified as Class I medical devices. This means that manufacturers, own branders, and assemblers of these (as defined below) must register with MHRA.
Glazing and Surfacing Under the Medical Devices Regulations
Glazing of spectacle frames is classed as assembly and the surfacing of spectacle lenses is classed as manufacturing. If a practice receives remotely edged lenses and fits them into a new frame, this is also considered to be assembly.
In the past this registration was done using form RG2, but this has been replaced by a completely online registration protocol.
Registration is chargeable and is currently a one-off process.
It should be noted that for multiple groups the law is not absolutely clear and MHRA will judge each case on its own merits. However, to date, where there is a direct managerial link between head office and practices, i.e., they are one organisation, the MHRA has allowed the head office to register on behalf of their practices. This minimises the administrative burden on all sides as well as making sure that all sites which should be registered are registered. Multiple groups should continue to operate on this understanding and contact their representative body if they have any problems.
Future changes
The MHRA is currently consulting on proposals to amend and update the regulation of medical devices in the UK. This may result in changes in due course. However the MHRA have said that they do not intend to bring in changes until July 2023 at the earliest. Until then the MDR 2002 will continue to apply.
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