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.

Medical Guidelines & Recommendations

Clinical guidelines, regulatory resources, and compliance tools

731 resources

All Medical Guidelines & Recommendations 731 American Guidelines 221 European Guidelines 510

731 resources

ESE Guidelines: Management of Primary Aldosteronism

Clinical Guideline 2021 Endocrinology, Diabetes & Metabolism European Guidelines

Clinical Guideline by ESE in Endocrinology, Diabetes & Metabolism (2021).

Medical Guidelines & Recommendations

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

ESA Guidelines: Perioperative Anaesthesia in Adult Patients

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

EORTC/ISCL/USCLC Guideline: Primary Cutaneous Lymphomas

ERAS Guidelines: Perioperative Care in Elective Colonic Surgery

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

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