International Medical Device Regulators Forum medical device guidance

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

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

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

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

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

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

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

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.

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

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

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

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

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

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

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

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.

Key definitions for Software as Medical Device. Foundation terminology document distinguishing SaMD from SiMD.

Framework for SaMD risk categorization based on healthcare situation and significance of information. Foundation for global SaMD regulation.

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

QMS guidance specific to SaMD including software lifecycle, configuration management, and problem resolution.

Clinical evaluation guidance for Software as Medical Device. Covers valid clinical association, analytical validation, and clinical validation.

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