IVDMIA
The constellation of challenges to implementing the IVDR by next year have prompted players to openly call for its postponement and phased implementation.
While the human toll of the disease has been terrible, IVD makers also report there have been some positive developments, as demand has spiked and familiarity with testing has grown.
UK Introduces Bill to Guide Future IVD Regulation
The proposed Medicines and Medical Devices Bill updates the framework for regulating IVDs following the UK's exit from the EU.
After 'Difficult' 2019, European IVD Industry Looks Forward to Clarity on Brexit, IVDR in 2020
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IVD manufacturers are hoping questions related to the UK's pending exit from the EU, as well as the new European IVD Regulation, will soon be resolved.
New European IVDR Guidelines Issued for Cybersecurity
The 46-page document advises test makers on how to best implement cybersecurity measures under the new regulation, which is set to go into effect in 2022.