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.

Infectious Diseases & Microbiology

Clinical guidelines, regulatory resources, and compliance tools

31 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

31 resources

Urinary tract infection (recurrent): antimicrobial prescribing

Clinical Guideline 2018-10-31 European Guidelines Infectious Diseases & Microbiology

Clinical Guideline by NICE in Infectious Diseases & Microbiology (2018).

Infectious Diseases & Microbiology

Urinary tract infection (recurrent): antimicrobial prescribing

Urinary tract infection in under 16s: diagnosis and management

Urinary tract infection (catheter-associated): antimicrobial prescribing

Tuberculosis

Suspected sepsis in under 16s: recognition, diagnosis and early management

Suspected sepsis in people aged 16 or over: recognition, assessment and early management

Suspected sepsis in pregnant or recently pregnant people: recognition, diagnosis and early management

Sore throat (acute): antimicrobial prescribing

Sinusitis (acute): antimicrobial prescribing

Secondary bacterial infection of eczema and other common skin conditions: antimicrobial prescribing

Otitis media (acute): antimicrobial prescribing

NICE NG63: Antimicrobial stewardship: systems and processes

NICE NG51: Sepsis: recognition, diagnosis and early management

NICE NG139: Urinary tract infection in adults

Meningitis (bacterial) and meningococcal disease: recognition, diagnosis and management

Lyme disease

Leg ulcer infection: antimicrobial prescribing

Insect bites and stings: antimicrobial prescribing

Impetigo: antimicrobial prescribing

Human and animal bites: antimicrobial prescribing

Healthcare-associated infections: prevention and control in primary and community care

HIV testing: increasing uptake among people who may have undiagnosed HIV

Cough (acute): antimicrobial prescribing

Clostridioides difficile infection: antimicrobial prescribing

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