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

2025 Focused Update: ESC/EAS Guidelines for the management of dyslipidaemias

2025 ESC/EACTS Guidelines for the management of valvular heart disease

2025 ESC Guidelines for the management of myocarditis and pericarditis

2025 ESC Guidelines for the management of cardiovascular disease and pregnancy

2025 ESC Clinical Consensus Statement on mental health and cardiovascular disease

2024 ESC Guidelines for the management of peripheral arterial and aortic diseases

2024 ESC Guidelines for the management of chronic coronary syndromes

2024 ESC Guidelines for the management of atrial fibrillation

2024 ESC Guidelines for the Management of Elevated Blood Pressure and Hypertension

2023 Focused Update: ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure

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