Engineering and scientific technologies company, Renishaw, will be exhibiting at the Digital Symposium at Swansea University on 29 June as part of its event, “Digital Futures in Health and Wellbeing: can public services survive without them?”.
Digital Futures Concept
The event will examine how businesses and infrastructure in the United Kingdom are preparing for the digital revolution. As part of the event’s focus on health services, Renishaw’s director and general manager of its Medical and Dental Products Division, Bryan Austin, will hold a seminar at the event as part of its focus on health services.
Austin will focus on the recent update to the European Medical Device Regulation (MDR) which suggests that any medical device mass produced by means of an industrial process no longer falls under the ‘custom-made’ exemption. These devices therefore require their own clinical evidence to authorise sustainability, as well as a CE mark to prove they have been tested and meet all relevant standards.
Problems surround a lack of clear definitions of ‘mass produced’ or ‘industrial manufacturing processes. There is a risk that some interpretations might include 3D printed patient specific implants when manufactured on an industrial scale, even though each one is unique.
Austin said: “Despite the European Medical Device Regulation being released, the subsequent guidance documents could be influenced if enough manufacturers have an input. Patient specific implants are already being used in surgeries across the world, with Renishaw working specifically with a number of Welsh hospitals to improve patient outcomes. An interpretation of the regulation as it currently stands may mean we will not be able to help patients in the same way. At the Digital Symposium, we hope to raise awareness of the new legislation amongst manufacturers."
