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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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June 20, 2022: UK government announced changes to simplify application of new product conformity markings for most products placed on the market in England, Scotland and Wales.

June 20, 2022: UK government announced changes to simplify application of new product conformity markings for most products placed on the market in England, Scotland and Wales.

Most important information at a glance:
All conformity assessment activities carried out by EU bodies before the end of 2022 will be taken into account as the basis for UKCA marking next year.

Related legislation will be enacted before the end of the year, allowing manufacturers to place the UKCA mark on these products without the need for re-testing and re-certification. This includes both products manufactured and imported into the UK by the end of 2022 and also spare parts that meet the same requirements.

In addition, legislation will be introduced to extend the current labeling easement, allowing key information and other UKCA markings to be placed on products by means of a sticky label or accompanying document until 31 December 2025.

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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