EU’s Risk Management Standard Officially Recognized In Context Of The IVDR
Only one new standard has been added to the official list of standards recognized in the context of the EU IVD Regulation in the latest update. The good news is that it is arguably one of the most needed standards by the IVD industry after the medtech quality management standard, ISO 13485.
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The European version of the international risk management standard, EN ISO 14971:2019, may have slipped through the net this January, but the European Commission has just published five new standards harmonized under the IVD Regulation.
The latest designation of a notified body in the context of the MDR means that the EU only needs one more to make the landmark total of 30. It seems that this may be realized soon.
Companies have been warned if they delay in applying for certification under the new Medical Device and IVD Regulations their products may not be reviewed in time. And the scale of the potential bottleneck is alarming.