DIAGNOSTICS
It is crucial that laboratories across the UK understand that – until at least 2030 – IVD products with a CE mark are accepted in the Great Britain market, and we are likely to see a mix of CE and UKCA marks for valid products
been introduced to Parliament to help ensure continued supply into the UK market and are likely to relieve some pressure on the medical device and IVD industry. These changes extend the supply of CE marked medical devices and IVDs into the Great Britain market until 2030, allowing continued access for patients. It’s likely that laboratories will be stocking products marked in different ways for the foreseeable future, with some labelled with UKCA, some with CE, and some with both.
Which transition timeline is applicable to a device is determined by a number of factors and is therefore unlikely to be identifiable by a user of a device, but understanding some of the complexity around timelines should help to alleviate some concern.
References 1 UK Parliament. The Medical
Device (Amendment) (Great Britain) Regulations 2023 (https://
www.legislFprliamation.gov.uk/ ukdsi/2023/9780348247657)
2 MHRA. Implementation of the Future Regulations. Medicines & Healthcare products Regulatory Agency 2023 (
https://www.gov.uk/government/ publications/implementation-of- the-future-regulation-of-medical- devices-and-extension-of-standstill- period/implementation-of-the-future- regulations)
3 MHRA. Medical devices: UK approved bodies. Medicines & Healthcare products Regulatory Agency 2021 (https://www.
gov.uk/government/publications/medical- devices-uk-approved-bodies)
4 European Commission. Notified
bodies NANDO 2017/745. European Union 2017 (
https://ec.europa.eu/ growth/tools-databases/nando/
index.cfm?fuseaction=directive. notifiedbody&dir_id=34)
5 European Commission. Notified bodies NANDO 2017/746. European Union 2017 (
https://ec.europa.eu/ growth/tools-databases/nando/
index.cfm?fuseaction=directive. notifiedbody&dir_id=35
6 European Commission. Factsheet for Manufacturers of in vitro diagnostic medical devices. European Union 2020 (
https://health.ec.europa.eu/system/ files/2020-09/ivd_manufacturers_ factsheet_en_0.pdf)
Ashleigh Batchen is Head of Regulatory Affairs, BIVDA.
Pathology in Practice has teamed up with BIVDA (the British In Vitro Diagnostics Association) to keep you up to date with the regulatory changes that you should be aware of.
Keep a look out for our future articles or contact Ashleigh for a discussion on how these changes might affect you and your organisation. For further information please visit the BIVDA website.
ashleigh@bivda.org.uk www.bivda.org.uk
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