Heading into 2015, the proposed European Medical Device Regulations (EMDR) still doesn’t have an end-date for completion or implementation. However, there’s no question that the changes are coming, and manufacturers—especially spine companies—should be prepared.
One of the more significant changes is the reclassification of CE-Marked spine implants from Class IIb devices to Class III. As a follow up to his December article on reclassification, while at OMTEC 2014, we asked Rob Packard to briefly state what spine companies can expect.
“Orthopaedic companies that make spinal implants will have to update their technical documentation to a higher quality of the design; they’re going to have to have more thorough clinical evaluations; there’s a lot more emphasis on postmarket clinical follow up plans,” he says. “The EU is looking at simple things like supplier quality agreements, identifying who your critical suppliers are. Everything is receiving more scrutiny.
“The Europeans are being tougher than anybody else in the world right now, and they’re going to get tougher—2015 will be a very tumultuous year for anybody in regulatory doing CE Marking work.”
The reclassification will consume spine companies’ internal resources, and could create a backlog of reviews for Notified Bodies. What can be done now to ensure that you’re prepared? A step-by-step look at how to convert your spinal technical file into a Class III design dossier can be found here.
|More on EMDR, including supply chain implications and unannounced audits, can be found in your December issue of BONEZONE. (Not sure if you're a subscriber? Confirm, here.)|