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.

Oncology & Haematology

Clinical guidelines, regulatory resources, and compliance tools

33 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

33 resources

ASH Guidelines for Sickle Cell Disease: Transfusion Support

Clinical Guideline 2020 American Guidelines Medical Guidelines & Recommendations

Clinical Guideline by ASH in Oncology & Haematology (2020).

Oncology & Haematology

ASH Guidelines for Sickle Cell Disease: Transfusion Support

ASH Guidelines for von Willebrand Disease

ASH Guidelines for Management of Venous Thromboembolism: Treatment of Deep Vein Thrombosis and Pulmonary Embolism

ASH Guidelines for Sickle Cell Disease: Cardiopulmonary and Kidney Disease

ASH Guidelines for Management of Venous Thromboembolism: Optimal Anticoagulant Therapy Duration

ASH Guidelines for Management of Venous Thromboembolism: Prophylaxis for Hospitalized Medical Patients

ASH Guidelines for Management of Newly Diagnosed Acute Myeloid Leukemia

ASH Guidelines for Immune Thrombocytopenia (ITP)

ASCO Guideline: Treatment of Patients With Early-Stage Colorectal Cancer

ASCO Guideline: Treatment of Small-Cell Lung Cancer

ASCO Guideline: Treatment of Pancreatic Cancer

ASCO Guideline: Treatment of Metastatic Renal Cell Carcinoma

ASCO Guideline: Treatment of Ovarian Cancer

ASCO Guideline: Treatment of Endometrial Cancer

ASCO Guideline: Treatment of Hepatocellular Carcinoma

ASCO Guideline: Systemic Therapy for Stage IV Non-Small-Cell Lung Cancer Without Driver Alterations

ASCO Guideline: Therapy for Stage IV Non-Small-Cell Lung Cancer With Driver Alterations

ASCO Guideline: Systemic Therapy for Metastatic Colorectal Cancer

ASCO Guideline: Sentinel Lymph Node Biopsy for Patients With Early-Stage Breast Cancer

ASCO Guideline: Systemic Therapy for Gastric/Gastroesophageal Junction Cancer

ASCO Guideline: Molecular Testing for Selection of Patients With Lung Cancer for Treatment With Targeted Therapy

ASCO Guideline: Selection of Optimal Adjuvant Chemotherapy and Targeted Therapy for Early Breast Cancer

ASCO Guideline: Management of Stage IV Breast Cancer

ASCO Guideline: Management of Chronic Lymphocytic Leukemia

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