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.

Regulatory Resources

Clinical guidelines, MDCG guidance, FDA guidance, standards, and compliance tools

208 resources

ATS/IDSA Practice Guidelines for Adults With Hospital-acquired and Ventilator-associated Pneumonia

Clinical Guideline 2016 American Guidelines Medical Guidelines & Recommendations

Clinical Guideline by ATS in Respiratory & Intensive Care (2016).

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ATS/ERS/JRS/ALAT Guideline for Diagnosis of Idiopathic Pulmonary Fibrosis

Clinical Guideline 2018 American Guidelines Medical Guidelines & Recommendations

Clinical Guideline by ATS in Respiratory & Intensive Care (2018).

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ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis

Clinical Guideline 2022 American Guidelines Medical Guidelines & Recommendations

Clinical Guideline by ATS in Respiratory & Intensive Care (2022).

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ATS/ERS Clinical Practice Guideline: Definition, Evaluation, and Treatment of Severe Asthma

Clinical Guideline 2014 American Guidelines Medical Guidelines & Recommendations

Clinical Guideline by ATS in Respiratory & Intensive Care (2014).

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ATS/CDC/IDSA Clinical Practice Guidelines: Treatment of Drug-Resistant Tuberculosis

Clinical Guideline 2022 American Guidelines Medical Guidelines & Recommendations

Clinical Guideline by ATS in Respiratory & Intensive Care (2022).

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ATS Guidelines for Pulmonary Rehabilitation in Adults

Clinical Guideline 2023 American Guidelines Medical Guidelines & Recommendations

Clinical Guideline by ATS in Respiratory & Intensive Care (2023).

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ATS Clinical Practice Guideline: Management of Obstructive Sleep Apnea in Adults

Clinical Guideline 2009 American Guidelines Medical Guidelines & Recommendations

Clinical Guideline by ATS in Respiratory & Intensive Care (2009).

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ATS Clinical Practice Guideline: Management of Adult Patients With Bronchiectasis

Clinical Guideline 2024 American Guidelines Medical Guidelines & Recommendations

Clinical Guideline by ATS in Respiratory & Intensive Care (2024).

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ASH Guidelines for von Willebrand Disease

Clinical Guideline 2021 American Guidelines Medical Guidelines & Recommendations

Clinical Guideline by ASH in Oncology & Haematology (2021).

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ASH Guidelines for Sickle Cell Disease: Transfusion Support

Clinical Guideline 2020 American Guidelines Medical Guidelines & Recommendations

Clinical Guideline by ASH in Oncology & Haematology (2020).

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Regulatory Resources

ATS/IDSA Practice Guidelines for Adults With Hospital-acquired and Ventilator-associated Pneumonia

ATS/ERS/JRS/ALAT Guideline for Diagnosis of Idiopathic Pulmonary Fibrosis

ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis

ATS/ERS Clinical Practice Guideline: Definition, Evaluation, and Treatment of Severe Asthma

ATS/CDC/IDSA Clinical Practice Guidelines: Treatment of Drug-Resistant Tuberculosis

ATS Guidelines for Pulmonary Rehabilitation in Adults

ATS Clinical Practice Guideline: Management of Obstructive Sleep Apnea in Adults

ATS Clinical Practice Guideline: Management of Adult Patients With Bronchiectasis

ASH Guidelines for von Willebrand Disease

ASH Guidelines for Sickle Cell Disease: Transfusion Support

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