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

Transition between inpatient mental health settings and community or care home settings

Clinical Guideline 2016-08-30 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by NICE in Neurology & Neurosurgery (2016).

Neurology & Neurosurgery

Transition between inpatient mental health settings and community or care home settings

Suspected neurological conditions: recognition and referral

Subarachnoid haemorrhage caused by a ruptured aneurysm: diagnosis and management

Stroke rehabilitation in adults

Spinal injury: assessment and initial management

Spasticity in under 19s: management

Social anxiety disorder: recognition, assessment and treatment

Service user experience in adult mental health: improving the experience of care for people using adult NHS mental health services

Rehabilitation for chronic neurological disorders including acquired brain injury

Rehabilitation for adults with complex psychosis

Psychosis and schizophrenia in children and young people: recognition and management

Preventing suicide in community and custodial settings

Post-traumatic stress disorder

Obsessive-compulsive disorder and body dysmorphic disorder: treatment

Neuropathic pain in adults: pharmacological management in non-specialist settings

NICE NG97: Dementia: assessment, management and support

NICE NG71: Parkinson’s disease in adults

NICE NG222: Depression in adults: treatment and management

NICE NG217: Epilepsies in children, young people and adults

NICE NG128: Stroke and transient ischaemic attack in over 16s

NICE CG178: Psychosis and schizophrenia in adults

NICE CG159: Bipolar disorder: assessment and management

NICE CG113: Generalised anxiety disorder and panic disorder

NICE CG150: Headaches in over 12s: diagnosis and management

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