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/N91 FINAL:2025: IMDRF Strategic Plan 2026-2030

IMDRF Procedural document 2025-12-19 IMDRF Documents

Procedural document published 2025 by IMDRF.

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ISO 10993-18:2020 — Biological evaluation — Part 18: Chemical characterization of medical device materials

ISO 10993 Series 2020-01-01 Standards

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ISO 10993-12:2012 — Biological evaluation — Part 12: Sample preparation and reference materials

ISO 10993 Series 2012-07-01 Standards

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ISO 10993-7:2008 — Biological evaluation — Part 7: Ethylene oxide sterilization residuals

ISO 10993 Series 2008-10-01 Standards

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ISO 11139:2018 — Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards

Sterilization Standard 2018-09-01 Standards

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ISO 17664-1:2021 — Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices

ISO Standard 2021-07-01 Standards

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ISO 14937:2009 — Sterilization of health care products — General requirements for characterization of a sterilizing agent

Sterilization Standard 2009-10-01 Standards

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ISO 13408-1:2008/AMD1:2013 — Aseptic processing of health care products — Part 1: General requirements

ISO Standard 2013-05-01 Standards

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ISO 14644-1:2015 — Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration

ISO Standard 2015-12-01 Standards

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ISO 5840-1:2021 — Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements

ISO Standard 2021-01-01 Standards

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Regulatory Resources

IMDRF/MC/N91 FINAL:2025: IMDRF Strategic Plan 2026-2030

ISO 10993-18:2020 — Biological evaluation — Part 18: Chemical characterization of medical device materials

ISO 10993-12:2012 — Biological evaluation — Part 12: Sample preparation and reference materials

ISO 10993-7:2008 — Biological evaluation — Part 7: Ethylene oxide sterilization residuals

ISO 11139:2018 — Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards

ISO 17664-1:2021 — Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices

ISO 14937:2009 — Sterilization of health care products — General requirements for characterization of a sterilizing agent

ISO 13408-1:2008/AMD1:2013 — Aseptic processing of health care products — Part 1: General requirements

ISO 14644-1:2015 — Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration

ISO 5840-1:2021 — Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements

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