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

1,129 resources

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

IMDRF Procedural document 2023-10-31 IMDRF Documents

Procedural document published 2023 by IMDRF.

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

IMDRF Procedural document 2023-10-31 IMDRF Documents

Procedural document published 2023 by IMDRF.

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

IMDRF Information document 2023-12-18 IMDRF Documents

Information document published 2023 by IMDRF.

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

IMDRF Information document 2024-02-08 IMDRF Documents

Information document published 2024 by IMDRF.

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IMDRF 25th MC Meeting Washington March 2024 – Outcome Statement

IMDRF Outcome statement 2024-03-28 IMDRF Documents

Outcome statement published 2024 by IMDRF.

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