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

Learning disabilities and behaviour that challenges: service design and delivery

Clinical Guideline 2018-03-28 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by NICE in Neurology & Neurosurgery (2018).

European Guidelines

Learning disabilities and behaviour that challenges: service design and delivery

Jaundice in newborn babies under 28 days

Intravenous fluid therapy in adults in hospital

Intravenous fluid therapy in children and young people in hospital

Intermediate care including reablement

Intrapartum care for women with existing medical conditions or obstetric complications and their babies

Insect bites and stings: antimicrobial prescribing

Inducing labour

Indoor air quality at home

Idiopathic pulmonary fibrosis in adults: diagnosis and management

Impetigo: antimicrobial prescribing

Hypertension in pregnancy: diagnosis and management

Hypothermia: prevention and management in adults having surgery

Human and animal bites: antimicrobial prescribing

Hyperparathyroidism (primary): diagnosis, assessment and initial management

Home care: delivering personal care and practical support to older people living in their own homes

Hepatitis B (chronic): diagnosis and management

Hip fracture: management

Heart valve disease presenting in adults: investigation and management

Heavy menstrual bleeding: assessment and management

Healthcare-associated infections: prevention and control in primary and community care

Hearing loss in adults: assessment and management

Head injury: assessment and early management

Haematological cancers: improving outcomes

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