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Medicines Authority GL-MDF21

GL-MDF21/02

Guidance for Application for Medical Device / In-Vitro Diagnostic Evaluation of Risk Classification
MaltaMedicines AuthorityClassification
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What this code is

GL-MDF21/02 is the official MMA identifier for “Guidance for Application for Medical Device / In-Vitro Diagnostic Evaluation of Risk Classification”. GL-MDF21/02 is the official identifier MMA uses for this instrument.

Instrument
GL-MDF21
Full name
GL-MDF21/02
Category
Classification
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English
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7 articles · 1 language version
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Dates
Published
August 2025
Effective
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About this regulation

Guidance for Application for Medical Device / In-Vitro Diagnostic Evaluation of Risk Classification

Medicines Authority guidance note GL-MDF21/02, Ref No. GL-MDF21/02, August 2025, on the application for a medical device or in-vitro diagnostic evaluation of risk classification. It is the Maltese route by which an applicant asks the authority to evaluate the risk class of a device, and it is the classification-specific guidance note in the authority's GL-MDF series. This is the shortest of the five guidance notes ingested, at eight blocks.

GL-MDF21/02 is the official identifier MMA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.

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