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

WHO Guideline: Recommended Composition of Influenza Virus Vaccines

Clinical Guideline 2024 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by WHO in Public Health & Primary Care (2024).

European Guidelines

WHO Guideline: Recommended Composition of Influenza Virus Vaccines

SIOPE/SIOP European Childhood Cancer Guidelines

WHO Guideline: Prevention and Control of Noncommunicable Diseases

ISPAD Clinical Practice Consensus Guidelines: Management of Type 1 Diabetes in Children

EuGMS Guidelines: Delirium in Older Adults

EuGMS Guidelines: Management of Falls in Older Persons

EURETINA Guidelines: Management of Diabetic Macular Oedema

EUGMS/ESPRM Guideline: Sarcopenia Diagnosis and Treatment

ESVS Guidelines: Management of Carotid Artery Disease

ETA Guidelines: Management of Thyroid Nodules

ESVS Guidelines: Management of Abdominal Aortic Aneurysms

ESUR Guidelines: Contrast Medium Safety

ESVS Guidelines: Chronic Venous Disease

ESR Guidelines: Appropriateness Criteria for Imaging

ESR/ESUR Guidelines: Gadolinium-Based Contrast Agent Hypersensitivity

ESPGHAN/NASPGHAN Guidelines for Helicobacter pylori Infection in Children

ESPRM Guidelines: Stroke Rehabilitation

ESPGHAN Guidelines: Management of Coeliac Disease in Children

ESPEN Guidelines: Nutrition in Older Persons

ESPGHAN Guidelines: Acute Gastroenteritis in Children

ESE Guidelines: Management of Primary Aldosteronism

ESE/ESPE Guidelines: Management of Turner Syndrome

ESE Guidelines: Management of Cushing’s Syndrome

ESA Guidelines: Perioperative Anaesthesia in Adult Patients

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