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.

Resources Archive

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Regulatory Resources

Fetal monitoring in labour

Fertility problems: assessment and treatment

Familial hypercholesterolaemia: identification and management

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

Faltering growth: recognition and management of faltering growth in children

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

Faecal incontinence in adults: management

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

Endometriosis: diagnosis and management

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

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