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

Tinnitus: assessment and management

Clinical Guideline 2020-03-11 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by NICE in Eye ENT & Neurosensory (2020).

Medical Guidelines & Recommendations

Tinnitus: assessment and management

Suspected sepsis in under 16s: recognition, diagnosis and early management

Thyroid cancer: assessment and management

Suspected sepsis in people aged 16 or over: recognition, assessment and early management

Suspected sepsis in pregnant or recently pregnant people: recognition, diagnosis and early management

Suspected neurological conditions: recognition and referral

Supporting adult carers

Suspected acute respiratory infection in over 16s: assessment at first presentation and initial management

Subarachnoid haemorrhage caused by a ruptured aneurysm: diagnosis and management

Sunlight exposure: risks and benefits

Stable angina: management

Stroke rehabilitation in adults

Spondyloarthritis in over 16s: diagnosis and management

Spinal injury: assessment and initial management

Spinal metastases and metastatic spinal cord compression

Spasticity in under 19s: management

Specialist neonatal respiratory care for babies born preterm

Sore throat (acute): antimicrobial prescribing

Sinusitis (acute): antimicrobial prescribing

Social anxiety disorder: recognition, assessment and treatment

Shared decision making

Sickle cell disease: managing acute painful episodes in hospital

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

Service user experience in adult mental health: improving the experience of care for people using adult NHS mental health services

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