Posts Tagged ‘recast’
European Commission to push ahead with recast?
In summer 2008 the European Commission revealed plans to “recast” the medical device regulatory framework in Europe (find document here). Following feedback from industry implementation was postponed but it now appears there is a move to pursue the recast.
At a recent device industry meeting in Rome Georgette Lalis, Director of the European Commission consumer products and industry division confirmed that “we will eventually deliver, under the new commission, a broader revision of the medical devices regulations in Europe”. It appears that the commission aims to have the new framework in place by 2015. A lot can obviously happen between now and then but we think one thing is for certain and that is there will be fundamental changes to the regulatory environment for medical devices in Europe over the next five years.
European Notified Bodies look to strengthen system
Read an interesting article lately that associations representing the majority of European Notified Bodies are working hard to finalise a paper outlining how they plan to strengthen their oversight of medical device manufacturers. This would appear to be in response to the European Commission’s proposed recast of the medical device directives but is the move too late, will it go far enough and how will it work given the diversity of the notified bodies? An issue we’ll definitely be keeping an eye on.
