International Medical Device Regulators Forum medical device guidance

Foundational guidance on conformity assessment methodology for medical device regulation. Establishes principles for demonstrating product compliance with regulatory requirements.

Framework for medical device classification based on risk. Establishes harmonized classification rules considering intended use, duration of contact, and invasiveness.

Standardized definitions for medical device and in vitro diagnostic medical device. Core terminology document for global regulatory alignment.

Guidance on manufacturer registration and device listing requirements. Outlines regulatory authority notification procedures and database submission.

Standardized definitions for supply chain participants including manufacturer, authorized representative, distributor, and importer roles and responsibilities.

Conformity assessment principles specific to in vitro diagnostic devices. Addresses IVD-specific evaluation requirements and compliance pathways.

Guidance on the use of international standards in medical device evaluation. Addresses standards recognition and application in regulatory assessment.

XML schema specification for electronic transfer of adverse event data between regulatory authorities and manufacturers. Enables standardized vigilance reporting.

Comprehensive guidance on post-market surveillance and adverse event reporting requirements for medical devices. Establishes global harmonized reporting criteria and timelines.

Guidance on the required content and format of field safety notices (FSN) for medical device recalls and corrective actions. Ensures consistent communication to users.

Harmonized system for grading QMS nonconformities during regulatory inspections. Enables consistent evaluation and information exchange between regulatory authorities.

Comprehensive guidance on CAPA processes within medical device quality management systems. Covers root cause analysis, corrective actions, and preventive measures.

Guidance on supplier control within QMS including supplier qualification, evaluation, and monitoring. Addresses purchased products and outsourced processes.

Integration of risk management principles into quality management systems. Addresses risk-based approach to QMS processes aligned with ISO 14971.

Guidance on process validation requirements for medical device manufacturing. Covers IQ, OQ, PQ protocols and ongoing process verification.

Guidance on clinical evidence requirements for IVD medical devices. Addresses evidence generation, clinical performance data, and regulatory submission requirements.

Guidance on establishing scientific validity and conducting performance evaluation for IVD devices. Covers analytical and clinical performance assessment.

Guidance on designing and conducting clinical performance studies for IVD devices. Covers study design, statistical considerations, and reporting requirements.

Guidance on reporting adverse events and other reportable events during pre-market clinical investigations. Covers reporting criteria, timelines, and procedures.

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

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

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

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

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

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