The decision to push back MDR’s implementation date by one year ostensibly bought companies and regulators time to prepare for the new system. But there remains a continuing scarcity of new notified bodies. Is that an indication that European officials are just kicking the can down the road so that industry can still expect a bottleneck, just one year later?Read Article
Stephen Levin has spent nearly 25 years covering the life sciences industry, writing and speaking primarily on medical technology worldwide. Before Levin and his partner, David Cassak, launched Innovation In Medtech, LLC, the parent company of MEDTECH STRATEGIST and MARKET PATHWAYS, along with international conferences, Levin formerly was Editor-in-Chief/Medical Devices at Elsevier Business Intelligence (EBI). At EBI, he directed the editorial coverage for the company’s medtech publications, including IN VIVO, START-UP, MEDTECH INSIGHT, THE GRAY SHEET, and THE SILVER SHEET, along with the content for the Investment In Innovation (IN3) series of medical device partnering conferences.
Prior to joining Windhover, Levin was Senior Counsel to the US Senate Permanent Subcommittee on Investigations, where he directed Senate investigations into a wide variety of areas including health care fraud and abuse, international organized crime, and corruption in federal contracting programs, while also participating in other Senate investigations, including the Whitewater inquiry. Before joining the Subcommittee, Levin was an enforcement and regulatory attorney in the Federal Election Commission’s Office of General Counsel, and also worked at the US Department of Justice. He was formerly an Editor of HEALTH INDUSTRY TODAY, a leading publication in the health care distribution industry.