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.

Regulatory Resources

Clinical guidelines, MDCG guidance, FDA guidance, standards, and compliance tools

161 resources

IMDRF/MDSAP WG/N22: MDSAP: Overview of Auditing Organization Assessment and Recognition Decision Related Processes

IMDRF Information document 2014-09-18 IMDRF Documents

Information document published 2014 by IMDRF.

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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.

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IMDRF/Standards WG/N15: Standards WG: Final Report: 'List of international standards recognized by IMDRF management committee members' Current as of: March 2014

IMDRF Information document 2014-11-21 IMDRF Documents

Information document published 2014 by IMDRF.

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

IMDRF Information document 2015-04-07 IMDRF Documents

Information document published 2015 by IMDRF.

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

IMDRF Information document 2015-07-08 IMDRF Documents

Information document published 2015 by IMDRF.

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

IMDRF Technical document 2015-10-02 IMDRF Documents

Technical document published 2015 by IMDRF.

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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 Information document 2015-10-02 IMDRF Documents

Information document published 2015 by IMDRF.

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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 Information document 2015-10-02 IMDRF Documents

Information document published 2015 by IMDRF.

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

IMDRF Information document 2015-10-02 IMDRF Documents

Information document published 2015 by IMDRF.

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

IMDRF Information document 2015-10-02 IMDRF Documents

Information document published 2015 by IMDRF.

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Regulatory Resources

IMDRF/MDSAP WG/N22: MDSAP: Overview of Auditing Organization Assessment and Recognition Decision Related Processes

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

IMDRF/Standards WG/N15: Standards WG: Final Report: 'List of international standards recognized by IMDRF management committee members' Current as of: March 2014

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

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

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

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

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

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