August 23, 2012

by Karen Brentnall

Medical device companies have one primary goal: to develop, manufacture and market a medical device that addresses an unmet market need. While it’s a common goal, the medical device regulatory approval process can be confusing for design and development engineers. They may hear terms such as “safety agency,” “CE mark,” “Notified body,” “510K” and “PMA” tossed around by quality and regulatory professionals. Although these terms are likely somewhat familiar, their true meanings and proper application are not always clear to many of us who are part of the development process. 

To commercialize any medical device, the appropriate regulatory process must be followed. This process varies depending on the country where the device is intended to be marketed and sold. So, how do medical device companies obtain approval of their products in Europe, in the US, and in other countries around the world? This three-part series will address what engineers need to know from a design and development standpoint. 

The first installment of this series will provide details about the CE Mark process in Europe.

CE Mark, Commercialization of Medical Devices in Europe

To sell a medical device on the European market, it must first be CE-marked. A CE mark on a medical device means that the product meets the essential requirements designated in Annex I of the Medical Device Directive (MDD) 93/42/CE. The MDD is a European Regulation which is intended to harmonize the laws within the European Union which pertain to medical devices…

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