Equipment sellers issued advice on MHRA and CE marking in event of ‘no-deal Brexit’

Britain Reacts To The EU Referendum Result

The Government has begun to publish documents advising different sectors and businesses on what preparations they should make in the event that Britain leaves the EU without a formal deal.

The first set of around 70 documents include some advice on medical devices and are designed to tackle fear and reassure UK’s businesses.

Ministers have maintained that they are still trying to reach a deal with the EU but said that industries must be prepared for every eventuality.

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One of the new documents (see MOVE section) gives advice on how Brexit will affect CE certification of medical devices by UK notified bodies.

The document entitled, Withdrawal of the UK and EU Rules in the Field of Industrial Products, states that “in view of the considerable uncertainties”, businesses are reminded of the potential legal repercussions of a ‘no-deal’ scenario.

After Brexit, UK notified bodies, such as The Medicines and Healthcare products Regulatory Agency (MHRA), whose mark allows a manufacturer to sell its equipment anywhere in the EU, will lose their status as EU notified bodies, meaning marks like MHRA will no longer be valid in the EU.

The Government advises businesses to ensure that they hold certificates issued by an EU body, such as CE, to demonstrate compliance for their products in the EU after Brexit.

Meanwhile, the document states that under EU rules, an importer is a business who brings a product to the EU market from a non-member country.

After the UK leaves the EU in March 2019, UK manufacturers or importers will no longer be considered a business in the EU.

This means that businesses that were formally considered to be EU distributors will now become classed as importers, which will mean companies will have to adhere to different rules.

The Government advises that manufacturers “take the necessary steps” to ensure that after Brexit their “responsible persons are established in the EU”.

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Tags : brexitcece markingequipmenteumanufacturersmedical device
Joe Peskett

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