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.

Women's Health & Obstetrics

Clinical guidelines, regulatory resources, and compliance tools

33 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

33 resources

Urinary incontinence and pelvic organ prolapse in women: management

Clinical Guideline 2019-04-02 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by NICE in Women's Health & Obstetrics (2019).

Women's Health & Obstetrics

Urinary incontinence and pelvic organ prolapse in women: management

Twin and triplet pregnancy

Specialist neonatal respiratory care for babies born preterm

Safe midwifery staffing for maternity settings

Postnatal care

Pregnancy and complex social factors: a model for service provision for pregnant women with complex social factors

Pelvic floor dysfunction: prevention and non-surgical management

Neonatal parenteral nutrition

NICE NG25: Preterm labour and birth

NICE NG235: Intrapartum care

NICE NG201: Antenatal care

NICE CG190: Caesarean birth

Menopause: identification and management

Maternal and child nutrition: nutrition and weight management in pregnancy, and nutrition in children up to 5 years

Long-acting reversible contraception

Jaundice in newborn babies under 28 days

Intrapartum care for women with existing medical conditions or obstetric complications and their babies

Inducing labour

Hypertension in pregnancy: diagnosis and management

Heavy menstrual bleeding: assessment and management

Fetal monitoring in labour

Fertility problems: assessment and treatment

Endometriosis: diagnosis and management

Ectopic pregnancy and miscarriage: diagnosis and initial management

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