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

22 resources

FD&C Act — Federal Food, Drug, and Cosmetic Act

Regulation 2024-01-01 Regulations US (FDA)

The foundational US law authorizing FDA to regulate medical devices. Sections 513–520 govern device classification, premarket review, postmarket requirements, and enforcement.

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France meeting outcome statement

IMDRF Outcome statement IMDRF Documents

Outcome statement published by IMDRF.

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Florianópolis meeting outcome statement

IMDRF Outcome statement IMDRF Documents

Outcome statement published 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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FDA Decisions for Investigational Device Exemption Clinical Investigations

FDA Guidance 2014-08-01 FDA Guidance

Final FDA guidance on ide. Published 2014 by CDRH/CBER.

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Factors to Consider When Making Benefit-Risk Determinations for Medical Device IDEs

FDA Guidance 2017-01-01 FDA Guidance

Final FDA guidance on ide. Published 2017 by CDRH/CBER.

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FDA and Industry Actions on 510(k) Submissions: Effect on FDA Review Clock and Goals

FDA Guidance 2017-10-01 FDA Guidance

Final FDA guidance on 510(k). Published 2017 by CDRH/CBER.

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FDA and Industry Actions on PMA Submissions: Effect on FDA Review Clock and Goals

FDA Guidance 2017-10-01 FDA Guidance

Final FDA guidance on pma. Published 2017 by CDRH/CBER.

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FDA Categorization of IDE Devices to Assist CMS with Coverage Decisions

FDA Guidance 2017-12-01 FDA Guidance

Final FDA guidance on ide. Published 2017 by CDRH/CBER.

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Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo

FDA Guidance 2019-08-01 FDA Guidance

Final FDA guidance on benefit-risk. Published 2019 by CDRH/CBER.

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Regulatory Resources

FD&C Act — Federal Food, Drug, and Cosmetic Act

France meeting outcome statement

Florianópolis meeting outcome statement

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

FDA Decisions for Investigational Device Exemption Clinical Investigations

Factors to Consider When Making Benefit-Risk Determinations for Medical Device IDEs

FDA and Industry Actions on 510(k) Submissions: Effect on FDA Review Clock and Goals

FDA and Industry Actions on PMA Submissions: Effect on FDA Review Clock and Goals

FDA Categorization of IDE Devices to Assist CMS with Coverage Decisions

Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo

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