For Medical Device Companies with Interests in the EEA
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.
European vs. United States Guidelines
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
Responsibilities for medical device manufacturers according to the MEDDEV-5 guidelines will include the following:
- The notification of NCAs (National Competent Authorities) regarding field safety corrective actions and medical device incidents;
- The investigation of medical device incidents;
- The application of corrective action procedures when necessary and/or applicable;
- The communication with authorized representatives (i.e. those that act in lieu of manufacturers) who are located in the EEA or within Switzerland regarding those guidelines set forth by the European Medical Device Vigilance System (or MEDDEV-5) guidelines.
Contact MasterControl Today for European Medical Device Vigilance System
To learn more about MEDDEV vigilance systems, feel free to contact MasterControl representative today.