EU IVDR: Risk Of Noncompliance Is A Real Threat Under Current Deadline Pressures
Cries for the EU to pay more attention to IVDs are growing louder by the day. It is feared the EU IVD sector is heading for a crisis and safe products will have to be pulled from the market.
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It seems that the medical device and IVD industries are clutching at straws if they expect the European Commission to agree to further delays in the EU medtech regulations.
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.