High Wycombe-based regulatory consultancy company Mosaic Surgical has formed a partnership with Key2Compliance – a Swedish provider of customised business solutions in the life sciences arena – to overcome some of the challenges associated with the UK leaving the European Union. From May 2021, medical device manufacturers outside of the UK wishing to sell their products into this market must do so with the representation of an appointed UK Responsible Person. This Responsible Person (which is not the same as a distribution partner) must be situated in the UK, and acts on behalf of the manufacturer to carry out specific tasks, such as registering devices with the MHRA – a legal requirement before products can enter the market.
Key2Compliance offers a full suite of services – including quality assurance, training and regulatory affairs – and, with Mosaic Surgical acting as its UK Responsible Person, the company can provide a one-stop shop to ensure uninterrupted trade with the UK. Jan Hellqvist, CEO of Key2Compliance, stated: “A number of our clients wish to continue to sell their products in the UK, so we are excited to support them through this transition, thanks to our partnership with Mosaic Surgical. Formation of this collaboration has been friction-free, which is exactly what we want for our customers, and we are pleased to recommend Mosaic Surgical as a UK Responsible Person.”
Heather Pendlebury, QARA Manager at Mosaic Surgical, said: “It’s extremely important to find someone in the UK that you can trust will act as a reliable representative following Brexit. We are delighted to be working with Key2Compliance, and have formed a very positive working relationship, which will help to make this process as smooth as possible for non-UK manufacturers.”