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.

Respiratory & Intensive Care

Clinical guidelines, regulatory resources, and compliance tools

29 resources

All European Guidelines 510 Cardiology & Vascular 47 Dermatology & Venereology 12 Endocrinology, Diabetes & Metabolism 19 Eye, ENT & Neurosensory 5 Gastroenterology & Hepatology 40 Imaging & Radiology 6 Infectious Diseases & Microbiology 31 Internal Medicine & Emergency 14 Medical Technology & Engineering Neurology & Neurosurgery 56 Oncology & Haematology 74 Paediatrics 16 Public Health & Primary Care 39 Rehabilitation & Geriatrics 15 Respiratory & Intensive Care 29 Rheumatology & Immunology 29 Surgery & Orthopaedics 30 Umbrella & Cross-Cutting 8 Women's Health & Obstetrics 33

29 resources

Suspected acute respiratory infection in over 16s: assessment at first presentation and initial management

Clinical Guideline 2023-10-31 European Guidelines Medical Guidelines & Recommendations

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

Respiratory & Intensive Care

Suspected acute respiratory infection in over 16s: assessment at first presentation and initial management

Rehabilitation after critical illness in adults

Pneumonia: diagnosis and management

Obstructive sleep apnoea/hypopnoea syndrome and obesity hypoventilation syndrome in over 16s

NICE NG80: Asthma: diagnosis, monitoring and chronic management

NICE NG191: COVID-19 rapid guideline: managing COVID-19

NICE NG115: Chronic obstructive pulmonary disease in over 16s

NICE NG117: Community-acquired pneumonia

Idiopathic pulmonary fibrosis in adults: diagnosis and management

Cystic fibrosis: diagnosis and management

Chronic obstructive pulmonary disease (acute exacerbation): antimicrobial prescribing

Bronchiolitis in children: diagnosis and management

Bronchiectasis (non-cystic fibrosis), acute exacerbation: antimicrobial prescribing

Asthma: diagnosis, monitoring and chronic asthma management (BTS, NICE, SIGN)

Asthma pathway (BTS, NICE, SIGN)

ESPEN Guideline on Clinical Nutrition in the Intensive Care Unit

ERS/ESICM/ESCMID/ALAT Guidelines for hospital-acquired and ventilator-associated pneumonia

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

ERS/ATS Guidelines on definition, evaluation and treatment of severe asthma

ERS/ATS Guidelines on management of COPD exacerbations

ERS Guidelines: Diagnosis and initial treatment of pulmonary embolism

ERS Guidelines: Management of adult community-acquired pneumonia

ERS Guidelines on the management of adult bronchiectasis

ERS Guidelines on the assessment of cough

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