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/AIMD WG/N67 (Edition 1): Machine Learning-enabled Medical Devices: Key Terms and Definitions

IMDRF Technical document 2022-05-09 IMDRF Documents

Technical document published 2022 by IMDRF.

IMDRF Documents

IMDRF/AIMD WG/N67 (Edition 1): Machine Learning-enabled Medical Devices: Key Terms and Definitions

Australia Virtual Meeting outcome statement

Australia Virtual Meeting outcome statement

IMDRF/CYBER WG/N70: Principles and Practices for the Cybersecurity of Legacy Medical Devices

IMDRF/PMD WG/N74: Personalized Medical Devices – Production Verification and Validation

IMDRF/CYBER WG/N73: Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity

IMDRF/MC/N77: White Paper – 23rd IMDRF Session Joint Workshop by IMDRF – DITTA and GMTA on the importance of post-market related activities

IMDRF 23rd MC Meeting Brussels March 2023 – Outcome Statement

IMDRF/MC/N78 FINAL:2023: IMDRF Strategic Plan 2021-2025 – Progress Report Card

IMDRF/MC/N76: Strategic Principles for IMDRF trainings

IMDRF/PMD WG/N58:2023 (Edition 2): Personalized Medical Devices – Regulatory Pathways

IMDRF 24th MC Meeting Berlin September 2023 – Outcome Statement

IMDRF/MC/N75 FINAL:2023 (Edition 2): IMDRF Working Group Membership Application Form

IMDRF/MC/N80: IMDRF 24th Session Workshop: White Paper on Specialized Regulatory Pathways

FOR GUIDANCE ONLY – IMDRF/MC/N69 FINAL:2023 (Edition 8): IMDRF Membership Application Form

IMDRF 25th MC Meeting Washington March 2024 – Outcome Statement

IMDRF/MC/N79: Guiding Principles to Support Medical Device Health Equity

IMDRF/GRRP WG/N71 FINAL:2024 (Edition 2): Medical Device Regulatory Review Report: Guidance Regarding Information to be Included

IMDRF/GRRP WG/N47 FINAL:2024 (Edition 2): Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices

IMDRF/GRRP WG/N40 FINAL:2024 (Edition 2): Competence, Training, and Conduct Requirements for Regulatory Reviewers

IMDRF/GRRP WG/N59 FINAL:2024 (Edition 2): Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews

IMDRF/GRRP WG/N52 FINAL:2024 (Edition 2): Principles of Labelling for Medical Devices and IVD Medical Devices

IMDRF/GRRP WG/N61 FINAL:2024 (Edition 2): Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews

IMDRF/GRRP WG/N66 FINAL:2024 (Edition 2): Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews

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