NBOG focus turns to notified body role in new and revised regulations
This article was originally published in Clinica
After a flurry of recent publications in March of key documents related to how notified bodies should audit their medical device clients, the Notified Bodies Operations Group (NBOG) is now anticipating the planned revision of the IVD Directive. It is looking at conformity assessment and related Notified Body issues within this context.
You may also be interested in...
The last year of the run up to the full implementation of the MDR has been characterized by a flurry of new documents and measures, but industry is adamant that medtech is heading for a crisis that will impact industry and patients alike.
With just a few months remaining until the full application of the EU Medical Device Regulation, notified body designations are still only trickling through. Ireland is the latest EU member state to have a resident MDR notified body.
In this second article of a two-part series, Eithne Lee of ISO Life Sciences global consultancy identifies some of the problems that medtech premarket innovators and SMEs are facing, with the EU MDR application date now less than four months away.