The recast of the Medical Devices Directive 2007/47/EC will see medical device manufacturers facing, among other things, more stringent clinical trials. How do you think these changes will affect our industry?
Les Farrington of - Binding Site - 18:39:42pm May-19th
I believe that companies should be pre-planning for regulation, both in the design phase and significently before a UK launch. Most devices will be launched internationally eventually, so this sort of trial should be a consideration in any case.
Peter Dines of - Surgi C - 12:17:38pm May-18th
We're currently using a patient outcome system, GPOS, which analyses patient outcomes for spinal disorders and we allow that data to be used for post-market clinical follow-ups. Patient safety is paramount in developing and using any new medical device, so increasing transparency is clearly a positive step that both SMEs and multinationals can achieve. As a distributer, we at Surgi C (www.surgi-c.com) have one concern, that there is no transitional period as the guidelines change, so every manufacturer has to adhere to the revised regulations instantly.
Trevor Lewis of - Medical Device Consultancy - 11:39:15am May-18th
Many small manufacturers now often feel overwhelmed by regulations, and it will definitely add some costs. But overall the changes are there to protect public health and many of the changes could have been avoided if companies had applied the original directives more rigorously. If manufacturers do not follow both the letter and spirit of the revision and recast, it is likely the industry will end up with a more prescriptive and inappropriate pharmaceutical-type regulation. All medical device manufacturers should be clear that demonstrating the system isn't broken and works well is definitely in their best interest - the alternatives are much worse!
