The Optical Suppliers Association (OSA) is reminding owners of optical practices that if they assemble spectacles or surface lenses in their practice, they must register with the Medicines and Healthcare products Regulatory Agency (MHRA).
The OSA has published a short guidance note explaining the requirements, which can be accessed on its website here.
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 that medical device regulations in the UK are unchanged. This means that all manufacturers, own branders, and assemblers of spectacles must register with the 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, the OSA highlighted.
Andy 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.”
View the MHRA’s legal requirements here.