IN A RECENT POLL ON OUR WEB site (www.24x7mag.com), we asked readers if they would like to design or modify medical devices. More than 80% said they would. Anyone designing a device will certainly have their eye on the international marketplace and will need to be aware of changes that will go into effect with the new Medical Device Directive (MDD) in 2010.
Approval of a new medical device directive, 2007/47/EC, came in September 2007, according to Claire McKenna, medical device program manager with the National Standards Authority of Ireland Inc, a company that provides medical device manufacturers with CE Markings, CMDCAS, and ISO 13485 certifications. The new directive ...