35 Notified Bodies In The Pipeline – But Heading For Catastrophe With Tight Timing?
New survey results suggest there could be a drop of about 40% in the number of EU notified bodies testing medical devices. A rough calculation points to an even bigger potential drop in the number that will be ready in time, when the Medical Device Regulation fully applies in 2020. A close look at newly available data signals the prospect for a serious bottleneck.
You may also be interested in...
The number of EU notified bodies applying for designation against the EU MDR has risen by over a third in the past nine months, the European Commission reports. IVDR applicant numbers are up slightly too. But are the increases enough to ease the anticipated bottlenecks?
Medtech stakeholders were reminded recently at the UK's largest regulatory forum that even those willing to make the best of Brexit are still working in the dark. The lack of useful government outreach is frustrating most efforts to secure business continuity. And that is without factoring in the huge regulatory changes that the EU's twin medical device regulations – the MDR and IVDR – will bring.
In an urgent notice to clients, notified body BSI warns that time is running out to recertify against the current EU directives, as pressures mount for all notified bodies.