Renishaw highlights MDR change

22 June 2017

Global engineering and scientific technologies company, Renishaw is exhibiting at the Digital Symposium at Swansea University on 29^th June, 2017 as part of its event, “Digital Futures in Health and Wellbeing: can public services survive without them?” The event will explore how the United Kingdom is preparing businesses and infrastructure for the digital revolution. Renishaw's Director and General Manager of its Medical and Dental Products Division, Bryan Austin, will also hold a seminar at the event as part of its focus on health services.

Austin's presentation will focus on the recent update to the European Medical Device Regulation (MDR), which was published in May, 2017. 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.

The problem is that 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.

“Despite the European Medical Device Regulation being released, the subsequent guidance documents could be influenced if enough manufacturers have an input,” explained Austin. “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.”

Renishaw will also exhibit its medical implants at the symposium. The company will showcase a recent case study on its work with Cardiff University. For further information on Renishaw visit www.renishaw.com/.