UK-based company Mosaic Surgical has announced a new fixed-fee service for UK Conformity Assessed (UKCA) marking with a notified body to support surgical products’ manufacturers and distributors that previously traded under EU law and CE marking before Brexit.
The move will help to ensure production continuity, conformity with sales legislation, and uninterrupted trade in the UK.
The UK has exited the EU with a trade deal that requires non-UK manufacturers to appoint a UK Responsible Person for their medical devices. Mosaic Surgical offers the UK Responsible Person service that enables the company to register their products with the Medicines and Healthcare products Regulatory Agency (MHRA).
With the new legislation for marketing products in the UK that came into effect on 1 January, most goods that were subject to the CE marking must now comply with and display UKCA marking instead.
Ireland-based company Idoman Teoranta was the first to receive Mosaic Surgical’s newly launched service and has entered an agreement to provide UKCA marking for its Thermablate EAS.
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Thermablate EAS is a handheld automated device for treatment of heavy menstrual bleeding.
It is manufactured by Idoman and distributed by JUNE Medical. It provides fast, safe, and effective ablation treatment in three minutes.
As part of the deal, Mosaic Surgical will take over the role of the UK Responsible Person to deliver a cost-effective route to UKCA marking.
Companies, including Synergo Medical and Neomedic, have also selected Mosaic Surgical as their UK representative.
JUNE Medical MD Emma Maidwell said: “As the distributor for Thermablate EAS, we are delighted to see that Mosaic Surgical, a reputable and knowledgeable company, is to become the UK Responsible Person for this product, smoothing the transition to UKCA marking.”
Mosaic Surgical is the manufacturing arm of a group of trusted medical device companies.