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.

European Guidelines

Clinical guidelines, regulatory resources, and compliance tools

510 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

510 resources

Blood transfusion

Clinical Guideline 2015-11-18 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by NICE in Oncology & Haematology (2015).

European Guidelines

Blood transfusion

Barrett’s oesophagus and stage 1 oesophageal adenocarcinoma: monitoring and management

Bedwetting in under 19s

Autism spectrum disorder in under 19s: support and management

Babies, children and young people’s experience of healthcare

Autism spectrum disorder in under 19s: recognition, referral and diagnosis

Autism spectrum disorder in adults: diagnosis and management

Attention deficit hyperactivity disorder: diagnosis and management

Asthma pathway (BTS, NICE, SIGN)

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

Antisocial personality disorder: prevention and management

Antimicrobial stewardship: changing risk-related behaviours in the general population

Antisocial behaviour and conduct disorders in children and young people: recognition and management

Anaphylaxis: assessment and referral after emergency treatment

Antenatal and postnatal mental health: clinical management and service guidance

Alcohol-use disorders: diagnosis and management of physical complications

Alcohol-use disorders: diagnosis, assessment and management of harmful drinking

Alcohol interventions in secondary and further education

Age-related macular degeneration

Air pollution: outdoor air quality and health

Acutely ill adults in hospital: recognising and responding to deterioration

Adrenal insufficiency: identification and management

Acute upper gastrointestinal bleeding in over 16s: management

Abortion care

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