The rapid advancement of medical technology has contributed to people living longer, healthier lives but consumer and campaign groups say devices should come under more scrutiny before they are used on patients.
Those calling for tighter rules in the EU will get a step closer to their aims when the new Medical Device Regulation (MDR) – due to enter into force in May – will include requiring manufacturers to give more information about devices and making it easier to trace and recall faulty products.
Industry representatives say they agree there should be a tougher legal framework but are wary that adding too much bureaucracy could “block innovation”. Campaigners say they await “the devil in the detail” but don’t believe the MDR has gone far enough.
Read more at https://euobserver.com/health/136825
As someone who’s doing a postgrad at UCL in physics and engineering I would also comment that too much regulation would block innovation. There needs to be more improvement in the categorising of medical regulation. If you’ve created a new proton beam that rips appart tumours quickly sure, you want strong regulation before it even gets close to a patient. However, basic patient monitoring is cheap and old. The excessive regulation here means that there is too little competition. Usually there’s only one supplier of a particular basic monitoring device that’s gone through the regulation. Others don’t bother because it’s not worth the heavy investment if someone is already in that space. The result, massive price hikes for outdated equipment. You can go on Amazon and get a blood pressure device that’s cheaper and better quality than what you’ll see in a hospital. The other thing is that because of the price hikes hospitals will over use and hold off on replacing equipment. This results in really dodgy equipment. The irony here is that the regulation that was ment to make the equipment safe has made it less safe. I can’t work out half the bizzare rules. One supplier of blood pressure monitors will be used in the ambulances but will not be allowed to be used in the hospitals because they didn’t adhere to some box in the regulations. It’s hard to write good regulation. And legal teams make a living using and abusing it to give the highest bidder an edge. Still thought provoking point. Glad you posted it.