Peter Rose published a recent article that makes a compelling case for Medical Device companies to act sooner, rather than later, to comply with the new European Union Medical Device Regulation (EUMDR).
Rose states: “Nobody is in any doubt that the new European Medical Device Regulation is on the agenda of compliance professionals in the medical devices industry. But is it far enough up on their priority list?
Early compliance to the EUMDR—the outline of which was finally published in the official Journal of the European Union on May 5, 2017—is crucial if manufacturers are to maintain access to EU markets, which in aggregate are economically larger than the United States.
A three-year compliance transition period was agreed, meaning that the EUMDR will not be fully in force until May 2020.However, medical device companies should not rest on their laurels. A significant stumbling block to compliance has already come to light: the potential under-capacity of compliance professionals both in terms of in-house specialists and notified bodies.
Pioneering manufacturers have much to gain by seizing the compliance initiative as early as possible. This will not only allow them to circumvent the capacity bottleneck, but will enable them to pick up business that non-compliant competitors will simply not be certified to service.”