New regulations, which were adopted on May 26, 2017, will affect all device and diagnostics manufacturers looking to sell products in the EU, with stricter requirements being introduced in order for these products to be approved. We are just over a year out from implementation of some of these European Union Medical Device Regulations (EUMDR), set for May 2020. With the deadline looming, how prepared should manufacturers be at this point – and how prepared are they?
Adam Steadman, Vice President, Clinical Development, Medical Devices & Diagnostics at Syneos Health, discusses the importance of these regulatory changes, highlights some of the key steps manufacturers need to take and examines the challenges inherent in gathering the data required for re-certification and ultimately, renewed market approval, in the EU.
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