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.

Neurology & Neurosurgery

Clinical guidelines, regulatory resources, and compliance tools

56 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

56 resources

Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management

Clinical Guideline 2021-10-29 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by NICE in Neurology & Neurosurgery (2021).

Neurology & Neurosurgery

Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management

Motor neurone disease: assessment and management

Mental health problems in people with learning disabilities: prevention, assessment and management

Mental health of adults in contact with the criminal justice system

Learning disabilities and behaviour that challenges: service design and delivery

Head injury: assessment and early management

Depression in adults with a chronic physical health problem: recognition and management

Depression in children and young people: identification and management

Delirium: prevention, diagnosis and management in hospital and long-term care

Coexisting severe mental illness and substance misuse: community health and social care services

Coexisting severe mental illness (psychosis) and substance misuse: assessment and management in healthcare settings

Challenging behaviour and learning disabilities: prevention and interventions

Cerebral palsy in adults

Care and support of people growing older with learning disabilities

Brain tumours (primary) and brain metastases in over 16s

Borderline personality disorder: recognition and management

Autism spectrum disorder in under 19s: support and management

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

Attention deficit hyperactivity disorder: diagnosis and management

Autism spectrum disorder in adults: diagnosis and management

Antisocial personality disorder: prevention and management

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

EAN/PNS Guideline on diagnosis and treatment of chronic inflammatory demyelinating polyradiculoneuropathy

EAN/ESO Guideline on acute ischaemic stroke management

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