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.

Medical Guidelines & Recommendations

Clinical guidelines, regulatory resources, and compliance tools

731 resources

All Medical Guidelines & Recommendations 731 American Guidelines 221 European Guidelines 510

731 resources

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

Clinical Guideline 2016-12-07 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by NICE in Rehabilitation & Geriatrics (2016).

Medical Guidelines & Recommendations

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

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

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