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.

Cardiology & Vascular

Clinical guidelines, regulatory resources, and compliance tools

47 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

47 resources

Venous thromboembolism in over 16s: reducing the risk of hospital-acquired deep vein thrombosis or pulmonary embolism

Clinical Guideline 2018-03-21 Cardiology & Vascular European Guidelines

Clinical Guideline by NICE in Cardiology & Vascular (2018).

Cardiology & Vascular

Venous thromboembolism in over 16s: reducing the risk of hospital-acquired deep vein thrombosis or pulmonary embolism

Varicose veins: diagnosis and management

Venous thromboembolic diseases: diagnosis, management and thrombophilia testing

Transient loss of consciousness (‘blackouts’) in over 16s

Stable angina: management

Prophylaxis against infective endocarditis: antimicrobial prophylaxis against infective endocarditis in adults and children undergoing interventional procedures

Peripheral arterial disease: diagnosis and management

NICE NG196: Atrial fibrillation: diagnosis and management

NICE NG185: Acute coronary syndromes

NICE NG136: Hypertension in adults: diagnosis and management

NICE NG106: Chronic heart failure in adults: diagnosis and management

NICE CG95: Chest pain of recent onset: assessment and diagnosis

NICE CG181: Cardiovascular disease: risk assessment and reduction

Heart valve disease presenting in adults: investigation and management

Familial hypercholesterolaemia: identification and management

Cardiovascular disease: risk assessment and reduction, including lipid modification

Acute heart failure: diagnosis and management

Abdominal aortic aneurysm: diagnosis and management

2025 ESC/EACTS Guidelines for the management of valvular heart disease

2025 Focused Update: ESC/EAS Guidelines for the management of dyslipidaemias

2025 ESC Guidelines for the management of myocarditis and pericarditis

2025 ESC Clinical Consensus Statement on mental health and cardiovascular disease

2025 ESC Guidelines for the management of cardiovascular disease and pregnancy

2024 ESC Guidelines for the management of chronic coronary syndromes

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