IVD Companies Brace For EU Regulatory Changes
The proposed EU In Vitro Diagnostics Regulation will introduce a tougher system of regulation that will bring increased intervention of notified bodies into the compliance pathway. Companies selling IVDs into the EU market are beginning to factor in rising costs and other challenges before it takes effect.
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This is the busiest time in the history of notified bodies as they try to process all manufacturers under the EU Medical Device Regulation (MDR). Making use of MDSAP audits is one way to cut down on work but is not always an option. The EU’s latest guidance explains the detail.
The MHRA has updated its guidance on regulatory flexibilities for medical devices and medicinal products resulting from COVID-19 to highlight how its approach differs from the EU.