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

Harmful sexual behaviour among children and young people

Clinical Guideline 2016-09-20 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by NICE in Public Health & Primary Care (2016).

European Guidelines

Harmful sexual behaviour among children and young people

Glaucoma: diagnosis and management

HIV testing: increasing uptake among people who may have undiagnosed HIV

Gambling-related harms: identification, assessment and management

Gastro-oesophageal reflux disease in children and young people: diagnosis and management

Gallstone disease: diagnosis and management

Food allergy in under 19s: assessment and diagnosis

Fractures (complex): assessment and management

Fetal monitoring in labour

Flu vaccination: increasing uptake

Fertility problems: assessment and treatment

Familial breast cancer: classification, care and managing breast cancer and related risks in people with a family history of breast cancer

Familial hypercholesterolaemia: identification and management

Falls: assessment and prevention in older people and in people 50 and over at higher risk

Faltering growth: recognition and management of faltering growth in children

Faecal incontinence in adults: management

Endometriosis: diagnosis and management

Excess winter deaths and illness and the health risks associated with cold homes

End of life care for adults: service delivery

End of life care for infants, children and young people with life-limiting conditions: planning and management

Ectopic pregnancy and miscarriage: diagnosis and initial management

Emergency and acute medical care in over 16s: service delivery and organisation

Eating disorders: recognition and treatment

Drug misuse prevention: targeted interventions

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