Electronic Instructions for use: survey |
About MedTech Europe
MedTech Europe is the European trade association for the medical technology industry including diagnostics, medical devices and digital health. Our members are national, European and multinational companies as well as a network of national medical technology associations who research, develop, manufacture, distribute and supply health-related technologies, services and solutions.
For more information, visit www.medtecheurope.org
For more information, visit www.medtecheurope.org
Background:
The EU Regulation 2017/746 allows Instructions for use (IFU) for all professional used in vitro diagnostic devices, except devices intended for near-patient testing, to be delivered in electronic format.
Many manufacturers already provide IFU in electronic format in addition to paper.
We would like to have a few minutes of your time to understand your preferences regarding the format of IFU for near-patient testing (NPT) devices.
Definitions & Abbreviations:
Near-patient testing/Point of care Device (NPT Device)
Device for near-patient testing means any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a health professional.
NPT Devices are usually used in the home, health centres, emergency rooms, out-patient clinics and hospitals.
Examples of usage of NPT Devices:
Test antigen SARS-COV-2 done by a pharmacist (Health professional) in the pharmacy (out of laboratory and near to the patient).
Test a patient in the hospital room by a nurse to verify the blood grouping before surgical intervention or transfusion.
Blood gas testing in an ambulance or emergency unit
Glucose meter for testing of e.g. children in school infirmary
Please Note: self-testing and laboratory devices are out of scope of this survey!
The EU Regulation 2017/746 allows Instructions for use (IFU) for all professional used in vitro diagnostic devices, except devices intended for near-patient testing, to be delivered in electronic format.
Many manufacturers already provide IFU in electronic format in addition to paper.
We would like to have a few minutes of your time to understand your preferences regarding the format of IFU for near-patient testing (NPT) devices.
Definitions & Abbreviations:
Near-patient testing/Point of care Device (NPT Device)
Device for near-patient testing means any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a health professional.
NPT Devices are usually used in the home, health centres, emergency rooms, out-patient clinics and hospitals.
Examples of usage of NPT Devices:
Test antigen SARS-COV-2 done by a pharmacist (Health professional) in the pharmacy (out of laboratory and near to the patient).
Test a patient in the hospital room by a nurse to verify the blood grouping before surgical intervention or transfusion.
Blood gas testing in an ambulance or emergency unit
Glucose meter for testing of e.g. children in school infirmary
Please Note: self-testing and laboratory devices are out of scope of this survey!