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.

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Regulatory Resources

NICE NG106: Chronic heart failure in adults: diagnosis and management

NICE NG101: Prostate cancer: diagnosis and management

NICE NG100: Rheumatoid arthritis in adults: management

NICE CG95: Chest pain of recent onset: assessment and diagnosis

NICE CG81: Breast cancer: advanced diagnosis and treatment

NICE CG79: Low back pain and sciatica in over 16s

NICE CG61: Irritable bowel syndrome in adults

NICE CG57: Atopic eczema in under 12s

NICE CG190: Caesarean birth

NICE CG184: Dyspepsia and gastro-oesophageal reflux disease

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