For medical device companies interested in the best-practice design, development, manufacture, marketing, sales and/or usage of medical device products within the European Economic Area (EEA) or Switzerland, the guidelines set forth by the European Commission in the newly revised European Medical Device Vigilance System should be observed.
Medical device companies accustomed to U.S. regulations may groan at the idea of managing additional regulatory requirements. However, many of the European regulations and guidelines often correspond with those published by major regulatory bodies within the United States. This may be due-at least primarily to the existence of the GHTF (Global Harmonization Task Force) which seeks "the standardization of medical device regulation across the world." The European Medical Device Vigilance System guidelines expressly state that MEDDEV-5 creators "carefully considered and transposed into the European context the Global Harmonization Task Force (GHTF) international regulatory guidance documents on vigilance and post market surveillance."
Responsibilities for medical device manufacturers according to the MEDDEV-5 guidelines will include the following:
To learn more about MEDDEV vigilance systems, feel free to contact MasterControl representative today.