Global Medtech Guidance Tracker: May 2021
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Fifty guidance documents have been posted on the tracker since its last update.
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The guidance documents outline the statutory authority the US FDA has in requiring postmarket surveillance reports and studies, the real-world evidence it plans to ask for from sponsors, and administrative details that may be expected.
Today marks the beginning of a new era. The MDR fully applies and companies can no longer be audited against the Medical Device and IVD Directives to claim compliance with EU regulations.
EU Regulatory Watershed Sees Widely Diverging Expert Views Over MDR As They Bid Farewell To Directives
Today marks the end of an era. Directives that have defined our working days for decades will now recede into history. Some have spoken of their nostalgia, some of optimism, and others of concerns. For one regulatory veteran, meanwhile, EU medtech is heading in the wrong direction.