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.

Public Health & Primary Care

Clinical guidelines, regulatory resources, and compliance tools

39 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

39 resources

WHO Guideline: Recommended Composition of Influenza Virus Vaccines

Clinical Guideline 2024 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by WHO in Public Health & Primary Care (2024).

Public Health & Primary Care

WHO Guideline: Recommended Composition of Influenza Virus Vaccines

WHO Guideline: Prevention and Control of Noncommunicable Diseases

ECDC Guideline: Prevention and Control of Seasonal Influenza

ECDC Guideline: Public Health Management of COVID-19

ECDC Guideline: Antimicrobial Resistance Surveillance

Workplace health: long-term sickness absence and capability to work

Workplace health: management practices

Violence and aggression: short-term management in mental health, health and community settings

Tobacco: preventing uptake, promoting quitting and treating dependence

Supporting adult carers

Shared decision making

Safeguarding adults in care homes

Physical health of people in prison

Physical activity and the environment

People’s experience in adult social care services: improving the experience of care and support for people using adult social care services

Patient experience in adult NHS services: improving the experience of care for people using adult NHS services

Oral health promotion: general dental practice

Oral health for adults in care homes

Medicines optimisation: the safe and effective use of medicines to enable the best possible outcomes

Medicines adherence: involving patients in decisions about prescribed medicines and supporting adherence

Indoor air quality at home

Harmful sexual behaviour among children and young people

Gambling-related harms: identification, assessment and management

Flu vaccination: increasing uptake

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