Industry leaders say approximately 50% of all medical devices will be withdrawn from the market; around 30% of manufacturers will not survive and patients might be at risk as a result of the European Medical Device Regulation (EU MDR), which is described by some as the “most disruptive force to European Healthcare since World War II”. Innovative high-risk medical devices receiving CE mark will fall by 70%, predict these experts who note that this is one of the most impactful pieces of legislation to hit the industry in decades.
A lunch symposium at the CX Innovation Showcase in 2019, chaired by Bob Mitchell (Irvine, USA) and Stephen Greenhalgh (London, UK), saw an august panel outlining what they thought were the key modifications needed to retain a competitive advantage for European medical device innovation. Aine Smalley (Santa Rosa, USA) mapped out the problem with existing timelines from a large company perspective; Gido Karges (Wangs, Switzerland) described the potential wipe-out of a sizeable number of small device companies; and Jeffrey Jump (Mont-sur-Rolle, Switzerland) highlighted the legislation’s devastating impact on innovation. They called for a prolongation of time to conform to the new MDR, a longer grace period for the recertification of older devices and a ‘fast-track’ Breakthrough Therapy designation for innovative devices, in which safety has been proven.
The MDR was initiated in May 2017, and a three-year transition period applies. Current MDD certificates remain valid, but cannot be renewed, meaning that from 26 May 2020 onwards, all medical devices brought to market in the European Union and Switzerland must conform to the MDR.