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

EAU Guidelines on Paediatric Urology

Clinical Guideline 2024 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by EAU in Paediatrics (2024).

Medical Guidelines & Recommendations

EAU Guidelines on Paediatric Urology

EAU Guidelines on Male Sexual Dysfunction

EAU Guidelines on Bladder Cancer (Non-muscle-invasive)

EAU Guidelines on Chronic Pelvic Pain

EASL Clinical Practice Guidelines: Wilson’s disease

EAU Guidelines on Bladder Cancer (Muscle-invasive and Metastatic)

EASL Clinical Practice Guidelines: Management of non-alcoholic fatty liver disease (NAFLD/MASLD)

EASL Clinical Practice Guidelines: Vascular diseases of the liver

EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma

EASL Clinical Practice Guidelines: Management of hepatitis B virus infection

EASL Clinical Practice Guidelines: Management of hepatitis C virus infection

EASL Clinical Practice Guidelines: Management of ascites, spontaneous bacterial peritonitis and hepatorenal syndrome

EASL Clinical Practice Guidelines: Management of cholestatic liver diseases

EASL Clinical Practice Guidelines: Liver transplantation

EASL Clinical Practice Guidelines: Management of alcohol-related liver disease

EASL Clinical Practice Guidelines: Hepatic encephalopathy in chronic liver disease

EASL Clinical Practice Guidelines: De novo autoimmune hepatitis after liver transplantation

EASL Clinical Practice Guidelines: Drug-induced liver injury

EAN/PNS Guideline on diagnosis and treatment of chronic inflammatory demyelinating polyradiculoneuropathy

EASL Clinical Practice Guidelines: Autoimmune hepatitis

EAN/ESO Guideline on acute ischaemic stroke management

EAN/EFNS Guideline on the diagnosis and management of Parkinson’s disease

EAN/EFNS Guideline on the management of amyotrophic lateral sclerosis (ALS)

EAN Guideline on the management of migraine

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