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

2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure

2020 ESC Guidelines on Sports Cardiology and Exercise in Patients with Cardiovascular Disease

2020 ESC Guidelines for the management of Adult Congenital Heart Disease

2019 ESC/EAS Guidelines for the management of dyslipidaemias

2019 ESC Guidelines on Supraventricular Tachycardia

2019 ESC Guidelines on Diagnosis and Management of Acute Pulmonary Embolism

2018 ESC/EACTS Guidelines on Myocardial Revascularisation

2018 ESC/EACTS Fourth Universal Definition of Myocardial Infarction

2018 ESC Guidelines for Diagnosis and Management of Syncope

ERS/ESTS Clinical Guidelines on fitness for radical therapy in lung cancer patients

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