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Medical Devices / Regulatory Affairs

EC Releases New Specs for Reprocessing Single-Use Devices Under New MDR

Aug. 13, 2019
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The European Commission released a draft regulation that offers specifications for reprocessing single-use medical devices that appears to offer flexibility but has received criticism from industry for being too restrictive.

The draft specifications lay down the rules for applying EU regulations 2017/745 for medical devices, allowing reprocessing of single-use devices where permitted by individual EU member states.

The Commission stresses that certain single-use devices are not suitable for reprocessing, such as those that emit radiation, incorporate drugs, or are used in invasive procedures on the central nervous system. Also excluded are implantable devices, devices with batteries that cannot be changed, or that have cutting or scraping blades that can’t be changed or sharpened before the next procedure.

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