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.

Paediatrics Archives

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Paediatrics

SIOPE/SIOP European Childhood Cancer Guidelines

ISPAD Clinical Practice Consensus Guidelines: Management of Type 1 Diabetes in Children

ESPGHAN/NASPGHAN Guidelines for Helicobacter pylori Infection in Children

ESPGHAN Guidelines: Management of Coeliac Disease in Children

ESPGHAN Guidelines: Acute Gastroenteritis in Children

ERS Task Force Guidelines: Management of Paediatric Asthma

Sedation in under 19s: using sedation for diagnostic and therapeutic procedures

NICE NG62: Cerebral palsy in under 25s: assessment and management

NICE NG204: Neonatal infection: antibiotics for prevention and treatment

NICE NG143: Fever in under 5s: assessment and initial management

Looked-after children and young people

Intravenous fluid therapy in children and young people in hospital

Developmental follow-up of children and young people born preterm

Bedwetting in under 19s

Babies, children and young people’s experience of healthcare

EAU Guidelines on Paediatric Urology

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