Opchat News finds out more answers on the new MDA regulations.

Opchat News finds out more answers on the new MDA regulations.

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“UKCA markings could leave sellers with a mountain of CE marked stock?” June 2021/industry

Following some questions you sent in to Opchat News we have further inquired about the status of ce marked stock after July 1st 2023.

We based our initial concerns on early information we received in correspondence with OSA (Optical Suppliers Guide) advisors.

Since then Ann Blackmore (OSA Advisor) has penetrated the grey depths of market law as it pertains to goods “placed” in the market and drawn significant distinctions between importers, distributors and retailers.

If you “placed” goods on the UK market (or in an EU or EEA state) before 1 January 2021, you do not need to do anything for these individual goods. EEA states include any country in the EU, Norway, Iceland and Liechtenstein.

This is important because goods “placed in the market” for the first time are the responsibility of the importer or the distributer who places new goods within a market such as the UK.

Once available in the market and passed to other wholesalers and retailers they can be available for sale even with a lone ce mark after July 2023. Therefore, all goods held in stock past this date will still be free of any restrictions to sell or be glazed.

We can therefore offer some relief that a “mountain of ce stock” or what is left on the shelves can continue to be sold to the end user or retailer.

This will provide relief to companies with large stocks of ce marked frames and sunglasses placed in the market before January 2021.
i.e. They can continue to circulate on either market until they reach their end user and do not need to comply with the changes that took effect from 1 January 2021.

Difference between an Importer and a distributor

You are an importer if you’re the first one bringing goods from outside the UK and “placing” them on the market in Great Britain. But If someone has already placed a good on the UK market before you sell it in Great Britain you will remain a distributor and will not have any additional responsibilities.

If the optician is directly importing the frames or lenses for their sole use, they are “placing” them on the market. So they will be recognised as importers in that case and must follow the rules for placing goods in the market which will need a UKCA marking, however the rules allow continued placement of CE marked goods until June 30th 2023 .

We belive It is possible to import frames and have them marked with both UKCA and CE marks, as we know imported medical devices can be CE marked, UKCA marked, or both..

As Ann commented “There are a whole lot of reasons for opticians taking a step back from importing directly because it looks like you take on a number of additional responsibilities as an importer, just be very aware of the implications.”

Ann Blackmore has been involved at almost all levels of European Laws effecting the Optical Confederation and is an independent adviser for the OSA.

Dates concerning MDA

January 2021
Goods placed on the market before this date can continue to be sold without any restriction.

January 2022

The conforming frames and lenses will need be marked with the term UKCA (UK Conformity Accessed).

30th June 2023.

After that date companies cannot sell to UK opticians products with CE sole markings not previously placed before January 1st 2021.

Importers, manufacturers and distributors placing goods for the first time in the market with conformity processes in place under the CE rules can also use them to apply for UKCA markings but will not need to make a formal application for UKCA certification.