OSA provides further assistance and guidance to the Optical Profession
Key notes for the Optical profession are that “Requirements for optical practices to register with the MHRA unchanged ”
The OSA held another long Zoom meeting with its key members who have volunteered to assist , regarding the finalisation of its stance to questions posed to it by the MHRA to ensure the lightest but safest of touches in the future legistlation on optical products. It has been doing so in tandem with the ACLM with their “Contact Lens Industry View”
The OSA are to be congratulated on their determination to keep as much red tape at bay given that the whole industry and profession have suffered so many setbacks due to the pandemic.
The OSA has reminded owners of optical practices that if they assemble spectacles or surface lenses in their practice, they must register with the MHRA.
The OSA have published a short guidance note explaining the requirements.
Andy Sanders, OSA Director, commented: “Following Brexit and the UK departure from the EU, alongside changes to the MHRA website, some practices have become confused about what they are now required to do. But it is important that practices are aware medical device regulations in the UK are unchanged. This means that all manufacturers, own branders, and assemblers of spectacles must register with MHRA.”
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.
Mr Sanders added: “The current MHRA consultation has no doubt added to the confusion. However, the MHRA have said that they do not intend to bring in changes until July 2023 at the earliest. Until then the existing rules will continue to apply.”
The Facts at present
1. You can access the OSA guidance note here
2. Spectacle lenses and frames are still classified as Class I medical devices.
3. 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.
4. 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.