The Life Science industry and regulatory profession have a plethora of acronyms and technical terms. Our glossary aims to help make sense of these. Search by clicking on the letters above.
Latest definitions
glossary
Incident for Medical Device (MEDDEV definition)
Any malfunction or deterioration in the characteristics and/or performance of a device, including use-error due to ergonomic features, as well…
glossary
Incident for IVDMD (IVDR definition)
Any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due…
glossary
In Vitro Diagnostic Medical Device (IVDMD)
Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or…
glossary
Expected Life of a Device
The time that a device is expected to remain functional after it is placed into use. Certain implanted devices have…
glossary
EUDAMED
The European database for medical devices EUDAMED is to centralize: Data relating to registration of manufacturers and medical devices placed…
glossary
Dysfunction
Failure of the medical device under investigation to function as intended when used in accordance with the instructions or the…
glossary
Device User Facility
A hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility as defined in this section, which…
glossary
International Birth Date (IBD)
The date of the first marketing authorization for any product containing the active substance granted to any company in any…
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