February 11, 2021
Mosaic Surgical Ltd is based in High Wycombe, UK.
Today the company announced a new fixed-fee service for UKCA marking with a UK notified body that will support manufacturers and distributors of surgical products that previously traded under EU law and CE marking before Brexit, and help to ensure continuity of production, conformity with sales legislation and, crucially, uninterrupted trade in the UK.
New legislation for marketing products in the UK came into force on January the 1st 2021, stipulating that most goods previously subject to the CE marking must now comply with and display UKCA marking instead.
The County Mayo-based company Idoman Teoranta was the first to recognise the value of Mosaic Surgical’s newly launched service, and has already entered into an agreement to deliver UKCA marking for its Thermablate EAS™, a handheld automated device for treatment of heavy menstrual bleeding.
Manufactured by Idoman and distributed by JUNE Medical, Thermablate EAS offers fast, safe and effective ablation treatment in just three minutes. Under the agreement, Mosaic Surgical will assume the role of the UK Responsible Person, providing a cost-effective route to UKCA marking. Other well-known companies that have also engaged Mosaic Surgical as their UK representative include Synergo Medical and Neomedic.
Emma Maidwell, Managing Director of JUNE Medical, commented: “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.”
