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Gloucestershire Business News

Technology specialists will showcase ground-breaking work

A global engineering and scientific technologies company based in Gloucestershire will be the focus of attention at an important event in Wales.

Renishaw is exhibiting at the Digital Symposium at Swansea University next Thursday as part of its event, 'Digital Futures in Health and Wellbeing: can public services survive without them?".

Renishaw will exhibit medical implants that it has developed at its base in Wotton-under-Edge.

The director and general manager of its Medical and Dental Products Division, Bryan Austin (pictured), will hold a seminar as part of a focus on health services.

Mr Austin's presentation will look at the recent update to the European Medical Device Regulation.

The regulation suggests that any medical device mass produced by means of an industrial process no longer falls under the 'custom-made' exemption and therefore requires its own clinical evidence to authorise its sustainability, along with its own CE mark to prove it has been tested and meets all relevant standards.

According to Renishaw, there aren't clear definitions of 'mass-produced' or 'industrial manufacturing processes', so 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.

Mr 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."

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