The European Medical Device Directive effective since 1998 will face a revision. It will have significant implications for manufacturers.The main change is the bigger emphasis on providing clinical data. Not only class IIb implants and class III devices have to be supported with clinical data, all devices need clinical evidence in the new revision. And for the high risk devices (implants and class III devices) a clinical investigation is expected unless strong substantial equivalence can be shown to identical devices described in scientific literature. 

KEMA can assist in reviewing clinical data or a clinical protocol at the start of the design process to prevent the risk of non-certification later.
Furthermore, the manufacturers will have to put more attention to gathering clinical experience data in daily practice. This post market surveillance requires a more active role of the manufacturer in analyzing his product and take action. An other important change is that software as a stand-alone product will be added to the definition of a medical device. Software has to fulfil the same requirements and undergo the same procedures as other medical devices.

The final draft of the MDD is now published on the Internet for public consultation (http://europa.eu.int/comm/enterprise/medical_devices/index_en.htm). The European Parliament will go into the directive this autumn. The earliest start of implementation will be the first quarter of 2006. It’s still unclear what the transition time will be. We will inform you when there’s more to say to it.