FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

EU Regulators Say Some Devices May Not Be Available Due to MDR Delays

July 9, 2019
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The European Commission acknowledged that there will likely be shortages of some devices due to delays in implementing the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).

In a new fact sheet, the commission said that the biggest change concerns the new risk-based classification of in vitro diagnostic devices and the role of notified bodies.

Under the new regulations, each IVD will be assigned to one of four risk classes, which means that  approximately 85 percent of all IVDs will need notified body oversight under the IVDR, compared to 20 percent previously.

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