Post-Brexit CE mark design unveiled by government


A new design for a post-Brexit CE mark has been unveiled and could replace the current CE mark if the UK leaves the EU without a deal next month.

The CE marking is placed on products including medical devices to show that they are compliant with the relevant EU regulatory requirements.

In most cases, the CE marking can be applied to products tested by the manufacturer.

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New CE marking design

For some products however, there is a legal requirement for the product to be assessed by a third-party assessment body, such as MHRA, to confirm they meet relevant regulatory requirements.

In a ‘no-deal’ scenario, the EU will stop recognising the competency of UK-based bodies to assess products for the EU market.

Therefore, manufacturers using UK-based bodies to assess products against the requirements of EU law will no longer be able to apply the CE marking.

The government intends to reclassify UK Notified Bodies as UK Approved Bodies. These bodies will be eligible to assess products against relevant UK requirements and issue the UK marking to compliant products.

In most cases, manufacturers would not need to use the UK marking immediately in the event of the UK exiting the EU without a deal.

Manufacturers will be able, for a period of time, to continue to use the CE marking when placing their products on the UK market if their product meets the relevant EU requirements.

This would include products that have had any necessary third-party assessment carried out by an EU-recognised body. The government would consult businesses before taking a decision on when this period would end.

Products being exported to the EU which currently require the CE marking will continue to require the CE marking to demonstrate compliance with the relevant EU regulatory requirements.

Last year, the government began to publish documents advising different sectors and businesses on what preparations they should make in the event that Britain leaves the EU without a deal.

Tags : brexitce markingmedical devicemhra
Joe Peskett

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