🌐GHTF/IMDRF Medical Device Regulations

Terminologies for Categorized Adverse Event Reporting (AER)

Standardized terminologies, terms, and codes for categorized adverse event reporting. Enables harmonized global vigilance data exchange.

Software-Specific Risk Characterization for Medical Device Software

Characterization considerations for medical device software and software-specific risk assessment. Covers intended purpose, algorithm design, and clinical context.

Good Machine Learning Practice (GMLP) for Medical Device Development

Guiding principles for good machine learning practice in medical device development. Addresses AI/ML lifecycle, data quality, and validation.

Common Data Set for Adverse Event Data Exchange Between Regulators

Common data set specification for adverse event data exchange between IMDRF regulatory authorities. Enables standardized vigilance information sharing.

Non-IVD Medical Device Regulatory Submission Table of Contents

Standardized table of contents for non-IVD medical device regulatory submissions. Edition 4 with updated structure for global harmonization.

IVD Medical Device Regulatory Submission Table of Contents

Standardized table of contents for IVD medical device regulatory submissions. Edition 4 with updated structure for global harmonization.

Principles of Labelling for Medical Devices and IVD Medical Devices

Harmonized principles for medical device labeling including label content, IFU, and e-labeling. Edition 2 with updated requirements.

Essential Principles of Safety and Performance

Essential principles of safety and performance for medical devices and IVD medical devices. Edition 2 foundation document for global regulatory alignment.

Personalized Medical Devices - Regulatory Pathways

Regulatory pathways for personalized medical devices including patient-matched and custom-made devices. Edition 2 with updated guidance.

Software Bill of Materials (SBOM) for Medical Device Cybersecurity

Principles and practices for Software Bill of Materials (SBOM) in medical device cybersecurity. Addresses component transparency and vulnerability management.