Essential IVD Document Delays Add To Concerns Over 2022 Deadline
The IVD Regulation is due to fully apply on 26 May 2022, but the infrastructure for manufacturers to demonstrate compliance and for notified bodies to perform their audits according to the new rules keeps being delayed.
You may also be interested in...
The IVD Regulation is due to fully apply in May 2022. The necessary infrastructure looks unlikely to be ready in time. But industry faces a dilemma: will lobbying and pining hopes on a delay be the best use of its resources?
Stakeholders have access to the first version of the European Medical Device Nomenclature, an aid to identifying the precise type of device being referred to. And their views on the naming system are being sought too.
The EU MDR date of application is three weeks away; while this date may look more tenable than before, deadlines in 2022 and 2024 leave the medtech industry, and especially its IVD sector, wondering how to stop products being lost from the market.