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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The technical storage or access is required to create user profiles to send advertising, or to track the user on a website or across several websites for similar marketing purposes.

Regulatory Resources

ASCO Guideline: Treatment of Endometrial Cancer

ASCO Guideline: Therapy for Stage IV Non-Small-Cell Lung Cancer With Driver Alterations

ASCO Guideline: Systemic Therapy for Stage IV Non-Small-Cell Lung Cancer Without Driver Alterations

ASCO Guideline: Systemic Therapy for Metastatic Colorectal Cancer

ASCO Guideline: Systemic Therapy for Gastric/Gastroesophageal Junction Cancer

ASCO Guideline: Sentinel Lymph Node Biopsy for Patients With Early-Stage Breast Cancer

ASCO Guideline: Selection of Optimal Adjuvant Chemotherapy and Targeted Therapy for Early Breast Cancer

ASCO Guideline: Molecular Testing for Selection of Patients With Lung Cancer for Treatment With Targeted Therapy

ASCO Guideline: Management of Stage IV Breast Cancer

ASCO Guideline: Management of Muscle-Invasive Bladder Cancer

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