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.

European Guidelines

Clinical guidelines, regulatory resources, and compliance tools

510 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

510 resources

ERS Guidelines on the diagnosis and treatment of chronic cough in adults and children

Clinical Guideline 2020 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by ERS in Respiratory & Intensive Care (2020).

European Guidelines

ERS Guidelines on the diagnosis and treatment of chronic cough in adults and children

ERS Guidelines on idiopathic pulmonary fibrosis treatment

ERS Guidelines on long-term home non-invasive ventilation

ERS Clinical Practice Guidelines: Management of obstructive sleep apnoea

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: Surgical Treatment

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

ECCO Guidelines on Reproduction and Pregnancy in IBD

ECCO Guidelines on Extraintestinal Manifestations of IBD

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

EAU Guidelines on Urolithiasis

EAU Guidelines on Urological Infections

EAU Guidelines on Urinary Incontinence in Adults

EAU Guidelines on Testicular Cancer

EAU Guidelines on Upper Urinary Tract Urothelial Carcinoma

EAU Guidelines on Prostate Cancer

EAU Guidelines on Renal Cell Carcinoma

EAU Guidelines on Neuro-urology

EAU Guidelines on Paediatric Urology

EAU Guidelines on Male Sexual Dysfunction

EAU Guidelines on Bladder Cancer (Non-muscle-invasive)

EAU Guidelines on Chronic Pelvic Pain

EASL Clinical Practice Guidelines: Wilson’s disease

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