RE: P2F Website updated27 Nov 2020 06:50
"Anyone out there have any knowledge of CE marking versus UKCA marking ? I’m just wondering whether RMS doing the final acceptance tests in Spain, presumably with masks being produced in the process, would allow a CE mark to be granted so that sales could be made to both the EU & UK after 1st Jan 2021 with no Brexit complications. If so, it could be a masterstroke. If not, don’t we need a UKCA mark to sell in UK after 1st Jan ?
Thanks in advance"
The final acceptance testing referred to relates to the machinery - not the masks.
CE marking is applied when the manufacturer and/or the Notified Body is/are satisfied that the conformity requirements are met. Exactly what is required will depend on which Annex of the EU Medical Devices Regulations the particular item falls into. But basically, in the case of the RMS masks, the 'manufacturer' for the purposes of the Regulations is P2F.
The change between CE and UKCA marking is complicated (what about Brexit isn't) as there will be transitional rules apply from 2021 - 2023, which are contingent of EU rules remaining the same.
The situation for Medical Devices is even more complicated as we (both the EU and the UK) are currently in a transition process between sets of Regulations. And - surprise, surprise - what will happen with medical devices from 1 January 2021 still hasn't been decided - despite this being a significant earner for the UK: $9.5 billion in 2019 as opposed to the fishing industry's $1.3 billion in 2019... and which has got more headlines as part of Brexit?
My best guess is that we'll end up with a system of dual marking CE/UKCA for many items - including medical devices. More regulatory burden and more costs for manufacturers....
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