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

Patient experience in adult NHS services: improving the experience of care for people using adult NHS services

Clinical Guideline 2012-02-24 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by NICE in Public Health & Primary Care (2012).

Medical Guidelines & Recommendations

Patient experience in adult NHS services: improving the experience of care for people using adult NHS services

Pelvic floor dysfunction: prevention and non-surgical management

Pancreatitis

Overweight and obesity management

Palliative care for adults: strong opioids for pain relief

Ovarian cancer: identifying and managing familial and genetic risk

Ovarian cancer: recognition and initial management

Otitis media with effusion in under 12s

Osteoporosis: assessing the risk of fragility fracture

Otitis media (acute): antimicrobial prescribing

Oral health promotion: general dental practice

Organ donation for transplantation: improving donor identification and consent rates for deceased organ donation

Older people: independence and mental wellbeing

Oral health for adults in care homes

Older people with social care needs and multiple long-term conditions

Obstructive sleep apnoea/hypopnoea syndrome and obesity hypoventilation syndrome in over 16s

Oesophago-gastric cancer: assessment and management in adults

Nutrition support for adults: oral nutrition support, enteral tube feeding and parenteral nutrition

Obsessive-compulsive disorder and body dysmorphic disorder: treatment

Neutropenic sepsis: prevention and management in people with cancer

Non-Hodgkin’s lymphoma: diagnosis and management

Neuropathic pain in adults: pharmacological management in non-specialist settings

NICE NG97: Dementia: assessment, management and support

Neonatal parenteral nutrition

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