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

2025 ACC/AHA/HFSA Guideline for the Management of High Blood Pressure in Adults

2025 ACC/AHA Guideline for the Management of Adults With Congenital Heart Disease

2024 ACC/AHA/AATS/PCNA/SCAI/STS Guideline for Perioperative Cardiovascular Management for Noncardiac Surgery

2024 ACC/AHA Guideline for the Management of Lower Extremity Peripheral Artery Disease

2024 ACC/AHA Guideline for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy

2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for Management of Patients With Chronic Coronary Disease

2023 ACC/AHA/ACCP/HRS Guideline for Diagnosis and Management of Atrial Fibrillation

2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure

2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease

2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain

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