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

Metastatic malignant disease of unknown primary origin in adults: diagnosis and management

Mental health problems in people with learning disabilities: prevention, assessment and management

Mental health of adults in contact with the criminal justice system

Menopause: identification and management

Meningitis (bacterial) and meningococcal disease: recognition, diagnosis and management

Melanoma: assessment and management

Medicines optimisation: the safe and effective use of medicines to enable the best possible outcomes

Medicines adherence: involving patients in decisions about prescribed medicines and supporting adherence

Maternal and child nutrition: nutrition and weight management in pregnancy, and nutrition in children up to 5 years

Major trauma: service delivery

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