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UKCA – Impact of UK Legislation on Market Access

Worldwide approvals and access to international markets

Currently the UKCA scheme very closely resembles the CE scheme, so in almost all cases wherever you are required to affix a CE mark for the EU market you will be required to affix a UKCA mark for the UK market. This is mostly on the product and often on the packaging also (in a few instances accompanying documentation is also accepted). This will be defined in the legislation applicable to your product.

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November 14, 2022: UK government extend recognition of CE mark for certain product categories until 2024.

November 14, 2022: UK government extend recognition of CE mark for certain product categories until 2024.

Per announcement from UK government, CE mark will continue to be recognized in the UK for another two years (until the end of 2024). During this time, both UKCA or CE mark may be used. Different rules will apply for medical devices, construction products, cableways, transportable pressure equipment, unmanned aircraft systems, rail products, and marine equipment.

Which consequences occur?
The government also declares to reviewing the wider product safety framework and prove further methods like e-labelling. Until 31 December 2027, the government will allow to affix the UKCA marking and include importer information for products from EEA countries on an accompanying document or label. Until this date, CE conformity assessment activities can also be used as the basis for the UKCA marking, when carried out before 31 December 2024.

What´s behind the change?
The decision is meant to provide relief to business costs for retesting and labelling and to allow them to focus on growth instead, considering the current difficult economic conditions.

For more information, please see the UK government website.

EU Regulation UK Regulation (UKAS and MHRA)
Medical Devices Regulation - 2017/745 (MDR)
In Vitro Diagnostics Regulation - 2017/746 (IVDR)
Medical Devices Regulations 2002
(The following EU Directives are given effect in UK law through the MDR 2002: Directive 93/42/EEC (medical devices), Directive 90/385/EEC (active implantable), and Directive 98/79/EC (in vitro diagnostics))

Events, FAQ, Downloads

Events

Join webinars and UKCA discussions.

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FAQ

Impact of UK Legislation

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Downloads

Download the FAQ and other documents.

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Contact

Please contact us for more information!

Please contact us for more information!

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