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

115 resources

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

IMDRF Information document 2016-09-30 IMDRF Documents

Information document published 2016 by IMDRF.

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

IMDRF Technical document 2016-03-24 IMDRF Documents

Technical document published 2016 by IMDRF.

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

IMDRF Information document 2017-03-16 IMDRF Documents

Information document published 2017 by IMDRF.

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

IMDRF Information document 2017-03-16 IMDRF Documents

Information document published 2017 by IMDRF.

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

IMDRF Technical document 2017-09-21 IMDRF Documents

Technical document published 2017 by IMDRF.

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Ottawa meeting outcome statement

IMDRF Outcome statement 2017-09-19 IMDRF Documents

Outcome statement published 2017 by IMDRF.

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

IMDRF Information document 2018-03-27 IMDRF Documents

Information document published 2018 by IMDRF.

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

IMDRF Technical document 2018-11-07 IMDRF Documents

Technical document published 2018 by IMDRF.

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IMDRF/RPS WG/N50: Round 2, RPS Beta Testing Report

IMDRF Information document 2018-07-27 IMDRF Documents

Information document published 2018 by IMDRF.

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IMDRF/RPS WG/N27 FINAL:2019: Assembly and Technical Guide for IMDRF Table of Contents Submissions

IMDRF Information document 2019-03-20 IMDRF Documents

Information document published 2019 by IMDRF.

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Regulatory Resources

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

IMDRF/RPS WG/N50: Round 2, RPS Beta Testing Report

IMDRF/RPS WG/N27 FINAL:2019: Assembly and Technical Guide for IMDRF Table of Contents Submissions

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