OSA MDR and EUROM Update – July 2021

The latest OSA briefing should serve as a good refresher for what we know so far.  There is an MDR regulation and legislation forum taking place on 13 July 2021.  Please contact [email protected]for full details.

UKCA and CE marking

Since 1 January 2021 manufacturers have been able to use the new UKCA mark on their medical devices. They may also choose to continue to use the CE mark until 30 June 2023, or they may choose to apply both a CE mark and a UKCA mark. With effect from 1 July 2023 all medical devices placed on the UK market must carry a UKCA mark.

Spectacle frames and lenses and ready readers are all Class 1 medical devices under both the Great Britain and EU systems of medical device regulation. In both systems the manufacturer of the device carries out the assessment of conformity (self assessment). There is no requirement (or indeed mechanism) for a formal application for a UKCA mark for Class 1 devices.

Medical devices placed on the market

The MHRA has made clear that

• the CE marking for medical devices will be unilaterally accepted in Great Britain until 30 June 2023
• from 1 July 2023 devices placed on the Great Britain market will need to meet the regulatory requirements for UKCA marking and a UKCA marking will be required.
• However, CE marked devices lawfully placed on the market prior to 1 July 2023 will be able to continue to circulate within Great Britain without being re-certified to UKCA marking requirements
• It will also be possible to place devices bearing both the CE and UKCA markings on the Great Britain market from 1 July 2023 so long as all the relevant regulatory requirements have been met.

What does placed on the market mean?

 When a manufacturer or an importer supplies a product to a distributor or an end-user for the first time, the operation is always labelled in legal terms as placing on the market. Any subsequent operation, for instance, from a distributor to distributor or from a distributor to an end-user is defined as making available.

It is important to note that the concept of placing on the market refers to each individual product, not to a type of product, and whether it was manufactured as an individual unit or in series. Therefore, even if a product model or type has been supplied with a CE marking up until 30 June 2023, individual units of the same model or type which are placed on the market from 1 July 2023, must comply with the UKCA requirements.

This means that an optical practice that still has in stock CE marked frames or ready readers purchased from a manufacturer or distributor can continue to make them available to customers from 1 July 2023.

However, all new stock placed on the market by the manufacturer from 1 July 2023 must be UKCA marked. An optical practice will therefore need to ensure that new stock they acquire from 1 July 2023 complies with this requirement.

It also means that it will be possible for an optician or a glazing house to reglaze CE marked frames from 1 July 2023 because those frames will have already been placed on the market.

Registration of actors and devices

Since 1 January 2021 all medical devices must be registered with the MHRA. However the transition timetable gives a deadline of 1 January 2022 for Class 1 medical devices. Additionally manufacturers who place medical devices on the Great Britain market must be registered with the MHRA.

Sunglasses

Plano or afocal sunglasses are not medical devices but covered instead by PPE regulations.  The extended period to use the CE mark that applies to medical devices does not apply to sunglasses.  Sunglasses with a CE mark can continue to be placed on the Great Britain market until 31 December 2022. From 1 January 2023 sunglasses placed on the Great Britain market will require a UKCA mark. However CE marked sunglasses that have already been placed on the Great Britain market (for example stock in an optical practice purchased from a manufacturer or importer) can continue to be sold to customers. The same deadline of 31 December 2022 applies to other CE marked goods (that are not medical devices).

Corrected 23 July 2021 to update reference to sunglasses and add in reference to ready readers.

Amended 26 August 2021 to update deadline for using CE mark for sunglasses and other goods.