The European Union’s (EU) revised Medical Devices Directive will go into effect in less than two years, and manufacturers that do not take advance steps to comply with it may face unnecessary delays in certification — or even lose certification.
However, many manufacturers do not seem to be taking the necessary steps to meet the March 2010 deadline, Claire McKenna, medical device program manager with the National Standards Authority of Ireland, told FDA News.
“I suppose the first thing we’ve noticed is people aren’t asking any questions because they don’t seem to be aware of it,” McKenna said. “Either they don’t know about it or they think it’s way down the road.”
The biggest change in the directive deals with clinical evaluations. Currently, companies can reference testing data for similar devices when applying for certification. But in 2010, the “literature comparison route” will require exact device comparisons, McKenna said.