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Surgical Innovations Reassigns Product Certifications To Netherlands

Wed, 20th Feb 2019 10:14

LONDON (Alliance News) - Surgical Innovations Group PLC said Wednesday it has reassigned all of its product certification to the Netherlands, in anticipation of a no-deal Brexit.

In November, the British Standards Institution - which produces technical standards - set up a Dutch body, allowing it to continue as a medical device notified body for EU directives.

Surgical Innovations said it successfully reassigned its products to the Netherlands notified body from the UK notified body, ensuring its products are certified in the EU.

Surgical Innovations - which designs and manufacturers products for use in the minimally invasive surgeries - said the move was a "contingency plan" against the possibility of the UK leaving the EU without an withdrawal agreement.

"Amidst speculation in the weekend press of possible disruption to the approvals status of medical devices across the EU following a no-deal Brexit, it is reassuring that we have taken this important precaution. Our first priority is to protect the integrity of our regulatory approvals for the EU market, and this will serve to reassure our distribution partners and end users of continuity in coming months," said Executive Chair Nigel Rogers.

Shares in Surgical Innovations were untraded Wednesday but last closed at 3.00 pence each.

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