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[유럽] MEDDEV 2.14 체외진단용 의료기기에 대한 가이던스

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MEDDEV 2.14/1 rev.2 Borderline and classification issues. A guide for manufacturers and notified bodies

January 2012

MEDDEV 2.14/2 rev.1 Research use only products

February 2004

MEDDEV 2.14/3 rev.1 Supply of instructions for use (IFU) and other information for in-vitro diagnostic (IVD) medical devices

January 2007

Form for the registration of manufacturers and devices in vitro diagnostic medical device

directive, article 10

January 2007

MEDDEV 2.14/4 CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP

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MEDDEV 2.14_4 CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP.pdf

Form for the registration of manufacturers and devices in vitro diagnostic medical device.pdf

MEDDEV 2.14_3 Supply of instructions for use (IFU) and other information for in-vitro diagnostic (IVD) medical devices.pdf

MEDDEV 2.14_2 Research use only products.pdf

MEDDEV 2.14_1 Borderline and classification issues. A guide for manufacturers and notified bodies.pdf