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.

Endocrinology, Diabetes & Metabolism

Clinical guidelines, regulatory resources, and compliance tools

19 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

19 resources

ETA Guidelines: Management of Thyroid Nodules

Clinical Guideline 2016 Endocrinology, Diabetes & Metabolism European Guidelines

Clinical Guideline by ETA in Endocrinology, Diabetes & Metabolism (2016).

Endocrinology, Diabetes & Metabolism

ETA Guidelines: Management of Thyroid Nodules

ESE Guidelines: Management of Primary Aldosteronism

ESE/ESPE Guidelines: Management of Turner Syndrome

ESE Guidelines: Management of Cushing’s Syndrome

ESE Guidelines: Management of Adrenal Incidentalomas

EASD/ADA Consensus Report: Management of Hyperglycaemia in Type 2 Diabetes

Overweight and obesity management

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

NICE NG28: Type 2 diabetes in adults: management

NICE NG18: Diabetes in pregnancy: management

NICE NG17: Type 1 diabetes in adults: diagnosis and management

NICE NG145: Thyroid disease: assessment and management

Hyperparathyroidism (primary): diagnosis, assessment and initial management

Faltering growth: recognition and management of faltering growth in children

Eating disorders: recognition and treatment

Diabetes (type 1 and type 2) in children and young people: diagnosis and management

Diabetic foot problems: prevention and management

Coeliac disease: recognition, assessment and management

Adrenal insufficiency: identification and management

Medical Device Navigator

Directory

Company

Content