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.

Oncology & Haematology

Clinical guidelines, regulatory resources, and compliance tools

74 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

74 resources

Vitamin B12 deficiency in over 16s: diagnosis and management

Clinical Guideline 2024-03-06 European Guidelines Medical Guidelines & Recommendations

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

Oncology & Haematology

Vitamin B12 deficiency in over 16s: diagnosis and management

Thyroid cancer: assessment and management

Spinal metastases and metastatic spinal cord compression

Sickle cell disease: managing acute painful episodes in hospital

Ovarian cancer: identifying and managing familial and genetic risk

Ovarian cancer: recognition and initial management

Oesophago-gastric cancer: assessment and management in adults

Neutropenic sepsis: prevention and management in people with cancer

Non-Hodgkin’s lymphoma: diagnosis and management

NICE NG85: Pancreatic cancer in adults: diagnosis and management

NICE NG199: Lung cancer: diagnosis and management

NICE NG197: Colorectal cancer: diagnosis and management

NICE NG161: Bladder cancer: diagnosis and management

NICE NG12: Suspected cancer: recognition and referral

NICE NG101: Prostate cancer: diagnosis and management

NICE CG81: Breast cancer: advanced diagnosis and treatment

Myeloma: diagnosis and management

Metastatic malignant disease of unknown primary origin in adults: diagnosis and management

Melanoma: assessment and management

Haematological cancers: improving outcomes

Familial breast cancer: classification, care and managing breast cancer and related risks in people with a family history of breast cancer

Early and locally advanced breast cancer: diagnosis and management

Colorectal cancer prevention: colonoscopic surveillance in adults with ulcerative colitis, Crohn’s disease or adenomas

Cancer of the upper aerodigestive tract: assessment and management in people aged 16 or over

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