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

71 resources

Providing Information about Pediatric Uses of Medical Devices

FDA Guidance 2014-05-01 FDA Guidance

Final FDA guidance on pediatric devices. Published 2014 by CDRH/CBER.

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Patient Preference Information — Voluntary Submission and Review in PMA/HDE/De Novo

FDA Guidance 2016-08-01 FDA Guidance

Final FDA guidance on patient engagement. Published 2016 by CDRH/CBER.

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Postmarket Management of Cybersecurity in Medical Devices

FDA Guidance 2016-12-01 FDA Guidance

Final FDA guidance on cybersecurity. Published 2016 by CDRH/CBER.

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Providing Regulatory Submissions for Medical Devices in Electronic Format — Section 745A(b)

FDA Guidance 2020-07-01 FDA Guidance

Final FDA guidance on submission process. Published 2020 by CDRH/CBER.

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Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments

FDA Guidance 2022-01-01 FDA Guidance

Final FDA guidance on clinical evidence. Published 2022 by CDRH/CBER.

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Policy for Device Software Functions and Mobile Medical Applications

FDA Guidance 2022-09-01 FDA Guidance

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

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Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices

FDA Guidance 2023-11-01 FDA Guidance

Final FDA guidance on export & international. Published 2023 by CDRH/CBER.

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Predetermined Change Control Plans for Medical Devices

FDA Guidance 2024-08-01 FDA Guidance

Draft FDA guidance on change management. Published 2024 by CDRH/CBER.

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Premarket Approval Application and Humanitarian Device Exemption Modular Review

FDA Guidance 2025-01-01 FDA Guidance

Final FDA guidance on pma. Published 2025 by CDRH/CBER.

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Position Paper: Demonstration of Safety and Performance for Combinatorial Use of Devices or Equipment

Position Paper 2026-02-16 Team NB Documents

Addresses requirements for demonstrating safety and performance when medical devices or equipment are used in combination.

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Regulatory Resources

Providing Information about Pediatric Uses of Medical Devices

Patient Preference Information — Voluntary Submission and Review in PMA/HDE/De Novo

Postmarket Management of Cybersecurity in Medical Devices

Providing Regulatory Submissions for Medical Devices in Electronic Format — Section 745A(b)

Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments

Policy for Device Software Functions and Mobile Medical Applications

Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices

Predetermined Change Control Plans for Medical Devices

Premarket Approval Application and Humanitarian Device Exemption Modular Review

Position Paper: Demonstration of Safety and Performance for Combinatorial Use of Devices or Equipment

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