Notified Body Numbers Continue To Fall
The number of notified bodies in the EU medtech arena continues to drop, as predicted, as the tougher new requirements for these organizations take hold. Here's a look at the country-by-country details.
You may also be interested in...
A Q&A with Guy Buijzen, of TEAM-NB, on where things stand for notified bodies right now as the EU moves to adopt the new regulations for devices and diagnostics. The EU notified body association is redoubling efforts to prepare its members for the coming changes.
How much faith do medtech regulatory experts have in the forthcoming medical device and IVD regulations and will they be ready on time? While the EU is making significant progress, experts continue to have serious concerns about implementation of the new regulations and the impact on industry.
EU power players are currently negotiating vast changes to how in vitro diagnostics are regulated in Europe. The resulting system will involve a lot more external oversight than today for most IVDs. Here's a rundown of what to expect.