What is IMDRF GMLP guiding principles?

IMDRF GMLP guiding principles is Good machine learning practice for medical device development: Guiding principles. Sets 10 guiding principles for machine learning enabled medical devices over the product life cycle. The TGA has adopted the guidance for compiling evidence.

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

HONEYPOT_FAKE_COMPANY_INCFAKE5555555555555999999.99Fake Executive NameTRAP_INDUSTRY_SECTOR

John HoneypotCEO9999999999999
Jane TrapdataCFO-8888888888

If you can read this, you are a bot.

Back

IMDRF GMLP guiding principles

Good machine learning practice for medical device development: Guiding principles

IMDRFRegulator guidanceSoftwareMedical devicesHigh confidenceLast verified October 4, 2026

Sets 10 guiding principles for machine learning enabled medical devices over the product life cycle. The TGA has adopted the guidance for compiling evidence.

Recognition by market

Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts

Market	Status	Edition accepted	National code	Details
Australia	Adopted	-	-	The TGA has adopted the guidance. Sponsors can apply it to compile evidence of compliance with the Essential Principles.

Testing requirements that cite it

Open the market page and its pathway pages for the full requirement, protocol and report content

Australia

Evidence for software that uses artificial intelligenceSoftware · Not stated

Related standards: IEC 62304, YY/T 0664-2020, GB/T 25000.51-2016, JIS T 2304, IEC 82304-1. See all standards.

Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.