Wiktoria Banczyk
Wiktoria Banczyk
MEDdesign

Ask the Expert: The Impact of IVD Regulations on Manufacturing

IVDR has significant implications for the manufacturing of IVD devices, as it requires manufacturers to comply with new and more rigorous regulatory requirements. Wiktoria Banczyk, Product Manager Lab Filtration Medical Devices at Sartorius Lab Instruments, discusses the challenges posed by the implementation of EU IVDR 2017/746 and key considerations for manufacturers as they navigate today’s regulatory landscape.

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EPA Logo
EPA Logo

EPA Announces Proposed Rules To Reduce Ethylene Oxide Exposure

By MedTech Intelligence Staff

If finalized, EPA’s proposals are estimated to cut EtO emissions to the air from commercial sterilization facilities by 80% per year and apply more protective standards to control those emissions under the law. But MedTech advocates are concerned that the EPA is overlooking the controls already in place and a lack of alternatives that could lead to patient risks.

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