FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

UK Announces No-Deal Brexit CE Mark Equivalent

Feb. 6, 2019
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The UK announced its post-Brexit, UK-specific product marking for certain marketed goods should the country depart the EU without agreeing on a deal.

The UK Conformity Assessed (UKCA) marking applies to certain products that are described in new guidance, “Trading Goods Regulated Under the ‘New Approach’ if There’s No Brexit Deal.”

The government said that most products currently covered by the CE Mark will fall under the UKCA marking’s scope. The requirements for the new marking will be the same as those that currently apply to CE Marking.

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