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

Ovarian cancer: identifying and managing familial and genetic risk

Clinical Guideline 2024-03-21 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by NICE in Oncology & Haematology (2024).

European Guidelines

Ovarian cancer: identifying and managing familial and genetic risk

Ovarian cancer: recognition and initial management

Otitis media with effusion in under 12s

Osteoporosis: assessing the risk of fragility fracture

Otitis media (acute): antimicrobial prescribing

Oral health promotion: general dental practice

Organ donation for transplantation: improving donor identification and consent rates for deceased organ donation

Older people: independence and mental wellbeing

Oral health for adults in care homes

Older people with social care needs and multiple long-term conditions

Obstructive sleep apnoea/hypopnoea syndrome and obesity hypoventilation syndrome in over 16s

Oesophago-gastric cancer: assessment and management in adults

Nutrition support for adults: oral nutrition support, enteral tube feeding and parenteral nutrition

Obsessive-compulsive disorder and body dysmorphic disorder: treatment

Neutropenic sepsis: prevention and management in people with cancer

Non-Hodgkin’s lymphoma: diagnosis and management

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

NICE NG97: Dementia: assessment, management and support

Neonatal parenteral nutrition

NICE NG80: Asthma: diagnosis, monitoring and chronic management

NICE NG85: Pancreatic cancer in adults: diagnosis and management

NICE NG71: Parkinson’s disease in adults

NICE NG63: Antimicrobial stewardship: systems and processes

NICE NG62: Cerebral palsy in under 25s: assessment and management

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