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.

Gastroenterology & Hepatology

Clinical guidelines, regulatory resources, and compliance tools

47 resources

All American Guidelines 221 Cardiology & Vascular 19 Dermatology & Venereology 7 Endocrinology, Diabetes & Metabolism 20 Eye, ENT & Neurosensory 7 Gastroenterology & Hepatology 47 Imaging & Radiology 5 Infectious Diseases & Microbiology 13 Internal Medicine & Emergency 4 Medical Technology & Engineering Neurology & Neurosurgery 12 Oncology & Haematology 33 Paediatrics 6 Public Health & Primary Care 8 Rehabilitation & Geriatrics 4 Respiratory & Intensive Care 8 Rheumatology & Immunology 11 Surgery & Orthopaedics 5 Umbrella & Cross-Cutting Women's Health & Obstetrics 12

47 resources

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).

Gastroenterology & Hepatology

AGA Clinical Practice Guideline on Management of Barrett’s Esophagus

AGA Clinical Practice Guideline on Management of Clostridioides difficile Infection

AGA Clinical Practice Guideline on Colorectal Cancer Screening

ACG Clinical Guideline: Ulcerative Colitis in Adults

ACG Clinical Guideline: Management of Helicobacter pylori Infection

ACG Clinical Guideline: Management of Irritable Bowel Syndrome

ACG Clinical Guideline: Management of Crohn’s Disease in Adults

ACG Clinical Guideline: Management of Acute Pancreatitis

ACG Clinical Guideline: Liver Cysts and Polycystic Liver Disease

ACG Clinical Guideline: Diagnosis and Management of Gastroesophageal Reflux Disease

ACG Clinical Guideline: Gallstone Disease and Cholecystitis

ACG Clinical Guideline: Diagnosis and Management of Celiac Disease

ACG Clinical Guideline: Colorectal Cancer Screening

AASLD/ACG Practice Guidance: Primary Biliary Cholangitis

AASLD/IDSA Recommendations for Treatment of Hepatitis C

AASLD Practice Guidelines: Management of Adult Patients with Ascites

AASLD Practice Guidance: Liver Transplant Evaluation

AASLD Practice Guidance: Portal Hypertensive Bleeding in Cirrhosis

AASLD Practice Guidance: Autoimmune Hepatitis

AASLD Practice Guidance: Diagnosis and Management of Hepatocellular Carcinoma

AASLD Practice Guidance on the Clinical Assessment and Management of NAFLD/MASLD

AASLD Practice Guidance: Alcoholic Liver Disease

AASLD Guidance on the Treatment of Hepatitis B Virus Infection

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