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

Early and locally advanced breast cancer: diagnosis and management

Clinical Guideline 2018-07-18 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by NICE in Oncology & Haematology (2018).

European Guidelines

Early and locally advanced breast cancer: diagnosis and management

Drug misuse in over 16s: opioid detoxification

Drug misuse in over 16s: psychosocial interventions

Donor milk banks: service operation

Drug allergy: diagnosis and management

Diverticular disease: diagnosis and management

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

Diabetic retinopathy: management and monitoring

Diabetes (type 1 and type 2) in children and young people: diagnosis and management

Diabetic foot problems: prevention and management

Developmental follow-up of children and young people born preterm

Depression in adults with a chronic physical health problem: recognition and management

Depression in children and young people: identification and management

Dementia, disability and frailty in later life – mid-life approaches to delay or prevent onset

Dental checks: intervals between oral health reviews

Decision-making and mental capacity

Delirium: prevention, diagnosis and management in hospital and long-term care

Cystic fibrosis: diagnosis and management

Controlled drugs: safe use and management

Cough (acute): antimicrobial prescribing

Community pharmacies: promoting health and wellbeing

Constipation in children and young people: diagnosis and management

Community engagement: improving health and wellbeing and reducing health inequalities

Coexisting severe mental illness and substance misuse: community health and social care services

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