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

ESE Guidelines: Management of Adrenal Incidentalomas

Clinical Guideline 2016 Endocrinology, Diabetes & Metabolism European Guidelines

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

European Guidelines

ESE Guidelines: Management of Adrenal Incidentalomas

ERS Task Force Guidelines: Management of Paediatric Asthma

EPOS2020: European Position Paper on Rhinosinusitis and Nasal Polyps

ERC Guidelines: Adult Basic Life Support and Automated External Defibrillation

ERAS Guidelines: Perioperative Care in Liver Surgery

ERAS Guidelines: Perioperative Care in Pancreaticoduodenectomy

ERAS Guidelines: Perioperative Care in Elective Colonic Surgery

EORTC/ISCL/USCLC Guideline: Primary Cutaneous Lymphomas

EHNS-ESMO-ESTRO Guidelines: Squamous Cell Carcinoma of the Larynx

EFSUMB Guidelines: Clinical Use of Liver Ultrasound Elastography

European Glaucoma Society Guidelines: Treatment of Open Angle Glaucoma

EUROGUIDERM Guideline: Diagnosis and Treatment of Mucocutaneous Pemphigus Vulgaris

EFORL Guidelines: Management of Otitis Media with Effusion

EDF Guideline: Management of Hidradenitis Suppurativa

EDF/EADV Guideline: Management of Psoriasis Vulgaris

EDF Guideline: Management of Atopic Dermatitis in Adults

ECDC Guideline: Prevention and Control of Seasonal Influenza

ECDC Guideline: Public Health Management of COVID-19

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

ECDC Guideline: Antimicrobial Resistance Surveillance

EANM/SNMMI Guidelines: Cardiac PET/CT Imaging

EANM/SNMMI Guidelines: FDG PET/CT in Oncology

EAES Guidelines: Laparoscopic Treatment of Hiatal Hernia

EADV Guideline: Management of Acne Vulgaris

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