New EU Regulations: What Could Possibly Go Wrong?
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.
You may also be interested in...
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.
The EU must have its new Eudamed database operating smoothly to support the implementation of the new IVD and Medical Device Regulations. But experience with its predecessor suggests progress may not always be straightforward.
Transitioning to the new EU IVD Regulation is going to require a major overhaul of processes and technical documents for IVD companies and also place heavy demands on EU notified bodies. So how long do those operating in the EU have to comply? And what is required in terms of governance? Some answers below.