Where are all the UK Approved Bodies?
We hear a lot about the lack of Notified Body capacity and if companies will be able to CE mark to the MDR/IVDR on time. But what about UKCA Marking?
Today, the MHRA allows companies to sell medical devices and IVDs in Great Britain (England, Scotland, Wales) based on their CE Marking. However, this is a temporary ‘Brexit’ transition measure only. By 1 July 2023 devices must have UKCA marking in order to continue being placed onto the market.
Does that seem far away? It’s not. It’s only about one year away from today. Consider how long it takes to CE mark a device. Have you left yourself enough time?
UKCA Marking is not just a matter of swapping out the CE symbol for the UKCA symbol. Devices that are Class I sterile, measuring, Class IIa, Class IIb and III require a UKCA marking certificate issued by a UK Approved Body , which is the UK equivalent of a European Notified Body. This means you need to contract with a UK Approved Body and undergo conformity assessment. The same is true for IVD self-test & Annex II, List A & List B devices.
Currently there are 13,750+ active manufacturers in the MHRA’s database. This does not consider that many manufacturers have 2, 3, even 10+ separate device families registered. Manufacturers will be competing with one another to obtain UKCA marking in the next year, so they can continue placing devices onto the market.
Note that Northern Ireland, the fourth UK country, will continue to require CE Marking and not UKCA marking.
There are several factors to consider here.