OPTICAL PRACTICES TO REGISTER WITH THE MHRA

OSA members may recall that we issued a press release towards the end of last year reminding optical practices who assemble, glaze or resurface spectacles that they must be registered with the MHRA.  This was shared with all of the optical sector professional and trade organisations, along with OSA guidance, since this requirement primarily affects their members.

The full guidance, including links on how to register with the MHRA is available in the link below. You may wish to share this with your own customers so they are fully informed of the process.

https://www.osa-uk.co.uk/requirements-for-optical-practices-to-register-with-the-mhra/

Medical devices: legal requirements for specific medical products – GOV.UK (www.gov.uk)

https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market

However, we are aware that the process for registering with the MHRA, and the guidance provided by the MHRA, is unclear and problematic.  The OSA is a member of the MHRA Devices Trade Associations Liaison Group, and our consultant, Ann Blackmore, has raised this issue on behalf of the wider optical sector at meetings of the Group and in writing with the MHRA.  The MHRA has taken these concerns on board and has committed to working with us to identify the solution and provide guidance to the optical sector. We will share any further information and ensuing guidance with members via either our Lens or Frames Focus Groups, MDR Forum or via the OSA office.

Please do not hesitate to contact [email protected] with any queries.