Regulatory


Regulating


or medical device manufacturers, the breadth of technologies on offer today represents real cause for excitement. AI is revolutionising diagnostics, while telemedicine is expanding access to healthcare and virtual reality is reshaping medical training. As we learn more about how to wield these technologies, the possibilities become more and more extensive. All this said, it’s not always straightforward to bring cutting-edge innovations to market. Many


F 18


innovation


in the UK


When done right, medical device regulation strikes the perfect balance between enabling innovation and upholding patient safety. It’s a challenge the UK government now faces following the recent launch of its Regulatory Innovation Offi ce (RIO). Designed to reduce the burden of red tape in gaining device approval, the move also aims to make it easier to invest in UK life sciences. Abi Millar talks to lawyers Anna Lundy and Peter Rudd-Clarke at Osborne Clarke, and Edward Emerson of TechUK, to fi nd out what this could mean for device makers.


manufacturers find themselves stumbling against regulatory barriers, which can delay product launches and bump up costs. As Anna Lundy, associate director in Osborne Clarke’s commercial and regulatory disputes team, explains, healthcare businesses may feel hampered by older regulatory frameworks. “Regulations such as the UK’s Medical Device Regulations are outdated and do not align with the rapid pace of technological advancement,” she says. “Even newer regulations, such as the EU Medical


Medical Device Developments / www.medicaldevice-developments.com


Panya_photo/Shutterstock.com


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