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

ESMO Clinical Practice Guidelines: Multiple Myeloma

Clinical Guideline European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by ESMO in Oncology & Haematology.

Medical Guidelines & Recommendations

ESMO Clinical Practice Guidelines: Multiple Myeloma

ESMO Clinical Practice Guidelines: Metastatic Breast Cancer

ESMO Clinical Practice Guidelines: Management of Febrile Neutropaenia

ESMO Clinical Practice Guidelines: Merkel Cell Carcinoma

ESMO Clinical Practice Guidelines: Malignant Pleural Mesothelioma

ESMO Clinical Practice Guidelines: Management of Cancer-Related Fatigue

ESMO Clinical Practice Guidelines: Hodgkin Lymphoma

ESMO Clinical Practice Guidelines: Hepatocellular Carcinoma

ESMO Clinical Practice Guidelines: High-Grade Gliomas

ESMO Clinical Practice Guidelines: Head and Neck Cancers

ESMO Clinical Practice Guidelines: Gastric Cancer

ESMO Clinical Practice Guidelines: Gastrointestinal Stromal Tumours (GIST)

ESMO Clinical Practice Guidelines: Early-Stage and Locally Advanced Non-Small-Cell Lung Cancer

ESMO Clinical Practice Guidelines: Follicular Lymphoma

ESMO Clinical Practice Guidelines: Early Breast Cancer

ESMO Clinical Practice Guidelines: Cutaneous Melanoma

ESMO Clinical Practice Guidelines: Diffuse Large B-Cell Lymphoma

ESMO Clinical Practice Guidelines: Chronic Lymphocytic Leukaemia

ESMO Clinical Practice Guidelines: Colon Cancer

ESMO Clinical Practice Guidelines: Cervical Cancer

ESMO Clinical Practice Guidelines: Cancers of Unknown Primary Site

ESMO Clinical Practice Guidelines: Cancer Pain Management

ESMO Clinical Practice Guidelines: Bone Sarcomas (ESMO-EURACAN)

ESMO Clinical Practice Guidelines: Breast Cancer in Young Women

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