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

Pancreatitis

Clinical Guideline 2018-09-05 European Guidelines Gastroenterology & Hepatology

Clinical Guideline by NICE in Gastroenterology & Hepatology (2018).

Gastroenterology & Hepatology

Pancreatitis

NICE NG49: Non-alcoholic fatty liver disease: assessment and management

NICE NG130: Ulcerative colitis: management

NICE CG61: Irritable bowel syndrome in adults

NICE CG184: Dyspepsia and gastro-oesophageal reflux disease

NICE CG152: Crohn’s disease: management

Hepatitis B (chronic): diagnosis and management

Gastro-oesophageal reflux disease in children and young people: diagnosis and management

Gallstone disease: diagnosis and management

Faecal incontinence in adults: management

Diverticular disease: diagnosis and management

Diarrhoea and vomiting caused by gastroenteritis in under 5s: diagnosis and management

Constipation in children and young people: diagnosis and management

Cirrhosis in over 16s: assessment and management

Barrett’s oesophagus and stage 1 oesophageal adenocarcinoma: monitoring and management

Acute upper gastrointestinal bleeding in over 16s: management

ESPEN Guideline on Clinical Nutrition in Liver Disease

ESPEN Guideline on Clinical Nutrition in Chronic Intestinal Failure

ESPEN Guideline on Clinical Nutrition in Inflammatory Bowel Disease

ECCO Guidelines on Therapeutics in Ulcerative Colitis: Medical Treatment

ECCO Topical Review on IBD in the Elderly

ECCO Guidelines on Therapeutics in Crohn’s Disease: Medical Treatment

ECCO Guidelines on Therapeutics in Crohn’s Disease: Surgical Treatment

ECCO Guidelines on Reproduction and Pregnancy in IBD

Medical Device Navigator

Directory

Company

Content