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

208 resources

AGA Clinical Practice Guideline on Management of Moderate-to-Severe Ulcerative Colitis

Clinical Guideline 2020 American Guidelines Gastroenterology & Hepatology

Clinical Guideline by AGA in Gastroenterology & Hepatology (2020).

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AGA Clinical Practice Guideline on Management of Mild-to-Moderate Ulcerative Colitis

Clinical Guideline 2023 American Guidelines Gastroenterology & Hepatology

Clinical Guideline by AGA in Gastroenterology & Hepatology (2023).

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AGA Clinical Practice Guideline on Management of Gastroparesis

Clinical Guideline 2022 American Guidelines Gastroenterology & Hepatology

Clinical Guideline by AGA in Gastroenterology & Hepatology (2022).

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AGA Clinical Practice Guideline on Management of Gastroesophageal Reflux Disease

Clinical Guideline 2022 American Guidelines Gastroenterology & Hepatology

Clinical Guideline by AGA in Gastroenterology & Hepatology (2022).

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AGA Clinical Practice Guideline on Management of Crohn’s Disease After Surgical Resection

Clinical Guideline 2017 American Guidelines Gastroenterology & Hepatology

Clinical Guideline by AGA in Gastroenterology & Hepatology (2017).

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AGA Clinical Practice Guideline on Management of Clostridioides difficile Infection

Clinical Guideline 2024 American Guidelines Gastroenterology & Hepatology

Clinical Guideline by AGA in Gastroenterology & Hepatology (2024).

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AGA Clinical Practice Guideline on Management of Barrett’s Esophagus

Clinical Guideline 2022 American Guidelines Gastroenterology & Hepatology

Clinical Guideline by AGA in Gastroenterology & Hepatology (2022).

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AGA Clinical Practice Guideline on Colorectal Cancer Screening

Clinical Guideline 2021 American Guidelines Gastroenterology & Hepatology

Clinical Guideline by AGA in Gastroenterology & Hepatology (2021).

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ADA Standards of Care in Diabetes — Retinopathy, Neuropathy, and Foot Care

Clinical Guideline 2025 American Guidelines Endocrinology, Diabetes & Metabolism

Clinical Guideline by ADA in Endocrinology, Diabetes & Metabolism (2025).

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ADA Standards of Care in Diabetes — Prevention or Delay of Diabetes and Associated Comorbidities

Clinical Guideline 2025 American Guidelines Endocrinology, Diabetes & Metabolism

Clinical Guideline by ADA in Endocrinology, Diabetes & Metabolism (2025).

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Regulatory Resources

AGA Clinical Practice Guideline on Management of Moderate-to-Severe Ulcerative Colitis

AGA Clinical Practice Guideline on Management of Mild-to-Moderate Ulcerative Colitis

AGA Clinical Practice Guideline on Management of Gastroparesis

AGA Clinical Practice Guideline on Management of Gastroesophageal Reflux Disease

AGA Clinical Practice Guideline on Management of Crohn’s Disease After Surgical Resection

AGA Clinical Practice Guideline on Management of Clostridioides difficile Infection

AGA Clinical Practice Guideline on Management of Barrett’s Esophagus

AGA Clinical Practice Guideline on Colorectal Cancer Screening

ADA Standards of Care in Diabetes — Retinopathy, Neuropathy, and Foot Care

ADA Standards of Care in Diabetes — Prevention or Delay of Diabetes and Associated Comorbidities

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