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OSA continues to bring clarity to what is needed for MHRA licensing 

OSA continues to bring clarity to what is needed for MHRA licensing

With considerable effort Ann Blackmore continues to ensure clarity and good advice to the OSA which is important for its members but also effects many optical practices in one way or another.

We bring together the latest information collated by the OSA for the UK optical market. 

The OSA has now agreed guidance to help those that need to register with the MHRA as an assembler of spectacles.

The guidance is attached here.Annex A Declaration of Conformity

The OSA thanks the MHRA for their support in developing this guidance, and they (the MHRA) have agreed to continue to work with the OSA to amend or update the guidance as necessary in light of experience and any future changes to the regulations.

Click here to download the Annex B Registering as an assembler

Assemblers should click here for the Guidance for assemblers of spectacles to register with the MHRA

RX Swimming Goggles

A question has arisen about the treatment of prescription swimming goggles. The OSA has now received confirmation from GMDN that refractive swimming goggles have now been added to the MHRA database, with the following definition:

“A non-prescription eyewear/eye protective device intended to be used to shield the eyes from water/chlorine during swimming/bathing and to provide a limited degree of refractive correction with ready-made lenses. This is a reusable device.”

A reminder of the position of stock marked CE after July 2023

The OSA reminds all as it did last year in its briefing document attached here for ease of reference, that  in summary, a CE marked product can continue to be sold after 1 July 2023 if it has already been placed on the UK market. That means that a manufacturer has already supplied the device direct to an optical practice or to a distributor in the UK.  However a subsequent batch of the same product, if put on the market after 1 July 2023 would need to be UKCA marked. There are no time limits on how long an optical practice can continue to supply CE marked goods that they have in stock.

 

 

 

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