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

75 resources

Manufacturing Site Change Supplements: Content and Submission

FDA Guidance 2018-12-01 FDA Guidance

Final FDA guidance on manufacturing. Published 2018 by CDRH/CBER.

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Multiple Function Device Products: Policy and Considerations

FDA Guidance 2020-07-01 FDA Guidance

Final FDA guidance on classification. Published 2020 by CDRH/CBER.

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Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices

FDA Guidance 2022-09-01 FDA Guidance

Final FDA guidance on software & digital health. Published 2022 by CDRH/CBER.

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Medical Device User Fee Small Business Qualification and Determination

FDA Guidance 2025-07-01 FDA Guidance

Final FDA guidance on user fees. Published 2025 by CDRH/CBER.

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Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions

FDA Guidance 2025-08-01 FDA Guidance

Final FDA guidance on ai/ml & software. Published 2025 by CDRH/CBER.

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MDCG 2019-7: Guidance on Article 15 – person responsible for regulatory compliance

MDCG Guidance 2023-12 MDCG Guidance Other / Transition

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MDCG 2023-1: Guidance on the health institution exemption under Article 5(5) of MDR and IVDR

MDCG Guidance 2023-01 MDCG Guidance Other / Transition

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MDCG 2021-3: Questions and Answers on Custom-Made Devices

MDCG Guidance 2021-03 MDCG Guidance Other / Transition

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MDCG 2022-11: Notice to manufacturers to ensure timely MDR/IVDR compliance

MDCG Guidance 2023-11 MDCG Guidance Other / Transition

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MDCG 2021-25: Application of MDR requirements to legacy devices placed on market prior to 26 May 2021

MDCG Guidance 2024-10 MDCG Guidance Other / Transition

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Regulatory Resources

Manufacturing Site Change Supplements: Content and Submission

Multiple Function Device Products: Policy and Considerations

Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices

Medical Device User Fee Small Business Qualification and Determination

Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions

MDCG 2019-7: Guidance on Article 15 – person responsible for regulatory compliance

MDCG 2023-1: Guidance on the health institution exemption under Article 5(5) of MDR and IVDR

MDCG 2021-3: Questions and Answers on Custom-Made Devices

MDCG 2022-11: Notice to manufacturers to ensure timely MDR/IVDR compliance

MDCG 2021-25: Application of MDR requirements to legacy devices placed on market prior to 26 May 2021

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