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

2020 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease

Clinical Guideline 2020 American Guidelines Cardiology & Vascular

Clinical Guideline by ACC/AHA in Cardiology & Vascular (2020).

Medical Guidelines & Recommendations

2020 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease

2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization

2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease

2019 AHA/ACC/HRS Focused Update on Atrial Fibrillation

2018 AHA/ACC Guideline for Management of Adults With Congenital Heart Disease (superseded 2025)

2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for Prevention and Management of High Blood Pressure in Adults

2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Bradycardia and Cardiac Conduction Delay

AASLD/ACG Practice Guidance: Primary Biliary Cholangitis

AASLD/IDSA Recommendations for Treatment of Hepatitis C

AASLD Practice Guidelines: Management of Adult Patients with Ascites

AASLD Practice Guidance: Liver Transplant Evaluation

AASLD Practice Guidance: Portal Hypertensive Bleeding in Cirrhosis

AASLD Practice Guidance: Autoimmune Hepatitis

AASLD Practice Guidance: Diagnosis and Management of Hepatocellular Carcinoma

AASLD Practice Guidance on the Clinical Assessment and Management of NAFLD/MASLD

AASLD Practice Guidance: Alcoholic Liver Disease

AASLD Guidance on the Treatment of Hepatitis B Virus Infection

AAN Practice Guideline: Treatment of Generalized Convulsive Status Epilepticus

AAN Practice Guideline: Treatment of Tremor

AAN Practice Guideline: Prevention of Episodic Migraine in Adults

AAN Practice Guideline: Reducing Brain Injury Following Cardiopulmonary Resuscitation

AAN Practice Guideline: Pharmacologic Treatment of Pediatric Migraine Prevention

AAN Practice Guideline: Pharmacologic and Nonpharmacologic Treatment of Acute Migraine

AAN Practice Guideline: MRI Screening for Unruptured Intracranial Aneurysms

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