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

40 resources

All European Guidelines 510 Cardiology & Vascular 47 Dermatology & Venereology 12 Endocrinology, Diabetes & Metabolism 19 Eye, ENT & Neurosensory 5 Gastroenterology & Hepatology 40 Imaging & Radiology 6 Infectious Diseases & Microbiology 31 Internal Medicine & Emergency 14 Medical Technology & Engineering Neurology & Neurosurgery 56 Oncology & Haematology 74 Paediatrics 16 Public Health & Primary Care 39 Rehabilitation & Geriatrics 15 Respiratory & Intensive Care 29 Rheumatology & Immunology 29 Surgery & Orthopaedics 30 Umbrella & Cross-Cutting 8 Women's Health & Obstetrics 33

40 resources

ECCO Guidelines on Prevention, Diagnosis, and Management of Infections in IBD

Clinical Guideline 2021 European Guidelines Gastroenterology & Hepatology

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

Gastroenterology & Hepatology

ECCO Guidelines on Prevention, Diagnosis, and Management of Infections in IBD

ECCO Guidelines on Extraintestinal Manifestations of IBD

EASL Clinical Practice Guidelines: Wilson’s disease

EASL Clinical Practice Guidelines: Management of non-alcoholic fatty liver disease (NAFLD/MASLD)

EASL Clinical Practice Guidelines: Vascular diseases of the liver

EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma

EASL Clinical Practice Guidelines: Management of hepatitis B virus infection

EASL Clinical Practice Guidelines: Management of hepatitis C virus infection

EASL Clinical Practice Guidelines: Management of ascites, spontaneous bacterial peritonitis and hepatorenal syndrome

EASL Clinical Practice Guidelines: Management of cholestatic liver diseases

EASL Clinical Practice Guidelines: Liver transplantation

EASL Clinical Practice Guidelines: Management of alcohol-related liver disease

EASL Clinical Practice Guidelines: Hepatic encephalopathy in chronic liver disease

EASL Clinical Practice Guidelines: De novo autoimmune hepatitis after liver transplantation

EASL Clinical Practice Guidelines: Drug-induced liver injury

EASL Clinical Practice Guidelines: Autoimmune hepatitis

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