What is an MDCG guidance document?

MDCG (Medical Device Coordination Group) guidance documents are non-binding technical guidance published by the European Commission to assist manufacturers, Notified Bodies, and competent authorities in implementing EU MDR 2017/745 and EU IVDR 2017/746. They cover clinical evaluation, post-market surveillance, UDI, EUDAMED, and other compliance topics.

What FDA guidance documents are required for a 510(k) submission?

FDA 510(k) submissions must follow applicable FDA guidance documents including the general 510(k) Guidance, device-specific guidances, and quality system regulation (21 CFR Part 820). Key documents include guidance on substantial equivalence determinations, cybersecurity pre-market requirements, and device-type-specific performance standards.

What is a Team NB document?

Team NB (Team of Notified Bodies) publishes position papers, recommendations, and guidance documents developed collaboratively by European Notified Bodies designated under EU MDR and IVDR. These documents clarify application of regulatory requirements and support harmonised conformity assessment practices across Notified Bodies.

What clinical guidelines are available on Medical Device Navigator?

Medical Device Navigator provides access to 700+ clinical guidelines and recommendations from major European and American medical societies including ESC, ESMO, EULAR, AHA/ACC, ASCO, ADA, NICE, and many more. Guidelines are organized by specialty and geographic scope (European vs American) to help medical device professionals understand clinical practice standards relevant to their devices.

IMDRF Documents

Clinical guidelines, regulatory resources, and compliance tools

115 resources

115 resources

IMDRF/SaMD WG/N12: Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations

IMDRF Technical document 2014-09-18 IMDRF Documents

Technical document published 2014 by IMDRF.

IMDRF Documents

IMDRF/SaMD WG/N12: Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations

IMDRF/RPS WG/N26: IMDRF Table of Contents (ToC) Pilot Plan

IMDRF/MC/N25: Statement regarding Use of ISO 14155:2011 "Clinical investigation of medical devices for human subjects – Good clinical practice"

IMDRF/MDSAP WG/N8: Guidance for Regulatory Authority Assessors on the Method of Assessment for MDSAP Auditing Organizations

IMDRF/MC/N37: Statement regarding Use of ISO 10993-1:2009 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process"

IMDRF/MC/N38: Statement regarding Use of ISO 11137-1:2006 "Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices"

IMDRF/MC/N35: Statement regarding Use of IEC 62304:2006 "Medical device software – Software life cycle processes"

IMDRF/MC/N36: Statement regarding Use of IEC 60601-1 "Medical electrical equipment – Part 1: General requirements for basic safety and essential performance"

IMDRF/RPS WG/N32: Strategic Assessment of Electronic Submission Messaging Formats

IMDRF/MC/N34: Statement regarding Use of ISO 14971:2007 "Medical devices – Application of risk management to medical devices"

IMDRF/NCAR WG/N31: Medical Devices: Post Market Surveillance: National Competent Authority Report (NCAR) Pilot Plan; Implementing Material

IMDRF/NCAR WG/N30: Medical Devices: Post-Market Surveillance -IMDRF National Competent Authority Report (NCAR) Pilot Plan

IMDRF/MDSAP WG/N29: Clarification of the Term "Legal Entity" for MDSAP Recognition Purposes

IMDRF/MDSAP WG/N24: Medical Device Regulatory Audit Reports

IMDRF/SaMD WG/N23: Software as a Medical Device (SaMD): Application of Quality Management System

IMDRF/RPS WG/N19: Common Data Elements for Medical Device Identification

IMDRF/REGISTRY WG/N33: Principles of International System of Registries Linked to Other Data Sources and Tools

IMDRF/MDSAP WG/N3: Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition

IMDRF RPS WG/N45: Data Exchange Guidelines – Common Data Elements for Medical Device Identification

IMDRF/Registry WG/N42: Methodological Principles in the Use of International Medical Device Registry Data

IMDRF/SaMD WG/N41: Software as a Medical Device (SaMD): Clinical Evaluation

Ottawa meeting outcome statement

IMDRF/Registry WG/N46: Tools for Assessing the Usability of Registries in Support of Regulatory Decision-Making

IMDRF/PMD WG/N49: Definitions for Personalized Medical Devices

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