Content area
Full Text
For companies that manufacture medical devices for the European market, the rules have just changed. The Medical Device Directive (MDD), which governs the process of CE Marking for medical devices, has recently been overhauled. The new MDD regulations will become mandatory in March 2010, but are already starting to be applied. Companies that aren't on top of the changes may find themselves facing delays or even lose certification if they're not taking steps today to ensure they comply with the new requirements.
Clinical Data
On the whole, most of the changes are clarifications to language, but there are some important aspects to consider, especially in regard to clinical data. Until now, most manufacturers of low-risk devices ignored this requirement completely. For higher-risk devices, companies had a choice of two ways in which they could provide clinical data on their products. The first was to conduct a clinical trial on the device. The second was to use equivalent clinical data from a similar product. Under the new MDD, this decision will be more regulated with new language clearly stating that clinical trials for high-risk classifications must be performed - unless other actions are duly justified.
For example, in just the first few weeks of 2009, I've had a number of clients who provided me with data that they hoped would allow them to use the equivalent data route to certify their product. However, in light of the new rules I had to tell them that the equivalent data weren't sufficient and they may have to perform a clinical trial. For example, one of my cHents was trying to get a CE Mark for a product used to repair a joint damaged by osteoarthritis. They found...