In a recent poll on this web site, 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 clarifies and updates the current MDD as well as the active implantable medical devices directive. "While most of the changes are truly clarifications, there are a number of changes that can drastically affect how companies achieve CE Marking for their products," McKenna said. The CE Marking—a compulsory conformity mark on many products placed on the single market in the European Economic Area—indicates that the product meets all the essential requirements of the relevant European Directive(s).

McKenna has identified a few areas that she believes will have the most impact on the medical device industry. "The biggest change in the directive is in the area of clinical evaluations," she said. While the current requirements for providing clinical data for medical products may be a bit murky, the new regulations explicitly define what clinical data is and what companies are expected to do to ensure safety and demonstrate the performance of their devices.

Another change entails the definition of a medical device. Software intended for diagnostic or therapeutic purposes will, for the first time, be classified as a medical device. Many software designers will now have to receive a CE Marking on their product prior to release in Europe.

New classification rules have moved some devices from the low-risk area into the high-risk category. "Companies may be very surprised to find that a product they are currently marketing will be required to have a design dossier or require a different CE Marking route after 2010," McKenna said.

Rules in the post market surveillance category also have been tightened to require companies to conduct sustained and coordinated clinical post market surveillance of their products.

Finally, McKenna suggests that manufacturers determine how the changes will affect them and what steps they need to take, especially for products already on the market that need certification reissued after a maximum of 5 years. "Many of the changes are significant and are not able to be made overnight," she said. "Companies need to start looking at their products in such a way as to ensure that they have the correct data and systems in place come 2010." Read more of her suggestions at www.nsaiinc.com.

Julie Kirst