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

Secondary bacterial infection of eczema and other common skin conditions: antimicrobial prescribing

Clinical Guideline 2021-03-02 European Guidelines Infectious Diseases & Microbiology

Clinical Guideline by NICE in Infectious Diseases & Microbiology (2021).

Medical Guidelines & Recommendations

Secondary bacterial infection of eczema and other common skin conditions: antimicrobial prescribing

Safe midwifery staffing for maternity settings

Safeguarding adults in care homes

Routine preoperative tests for elective surgery

Renal replacement therapy and conservative management

Rehabilitation for chronic neurological disorders including acquired brain injury

Renal and ureteric stones: assessment and management

Rehabilitation for adults with complex psychosis

Pyelonephritis (acute): antimicrobial prescribing

Rehabilitation after critical illness in adults

Prostatitis (acute): antimicrobial prescribing

Psychosis and schizophrenia in children and young people: recognition and management

Preventing suicide in community and custodial settings

Prophylaxis against infective endocarditis: antimicrobial prophylaxis against infective endocarditis in adults and children undergoing interventional procedures

Pressure ulcers: prevention and management

Postnatal care

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

Pneumonia: diagnosis and management

Post-traumatic stress disorder

Physical health of people in prison

Peripheral arterial disease: diagnosis and management

Physical activity and the environment

People’s experience in adult social care services: improving the experience of care and support for people using adult social care services

Perioperative care in adults

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