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.

Regulatory Resources

Clinical guidelines, MDCG guidance, FDA guidance, standards, and compliance tools

38 resources

Sickle cell disease: managing acute painful episodes in hospital

Clinical Guideline 2012-06-27 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by NICE in Oncology & Haematology (2012).

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Shared decision making

Clinical Guideline 2021-06-17 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by NICE in Public Health & Primary Care (2021).

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

Clinical Guideline 2011-12-14 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by NICE in Neurology & Neurosurgery (2011).

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

Clinical Guideline 2010-12-15 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by NICE in Paediatrics (2010).

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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).

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Safeguarding adults in care homes

Clinical Guideline 2021-02-26 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by NICE in Public Health & Primary Care (2021).

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Safe midwifery staffing for maternity settings

Clinical Guideline 2015-02-27 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by NICE in Women's Health & Obstetrics (2015).

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South Korea — Medical Devices Act (Act No. 17007)

Regulation 2020-02-18 Regulations South Korea (MFDS)

The South Korean Medical Devices Act (MFDS) governing approval, manufacturing, import, and post-market surveillance of medical devices. Last major amendment 2020.

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Singapore meeting outcome statement

IMDRF Outcome statement IMDRF Documents

Outcome statement published by IMDRF.

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Sydney meeting outcome statement

IMDRF Outcome statement IMDRF Documents

Outcome statement published by IMDRF.

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Regulatory Resources

Sickle cell disease: managing acute painful episodes in hospital

Shared decision making

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

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

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

Safeguarding adults in care homes

Safe midwifery staffing for maternity settings

South Korea — Medical Devices Act (Act No. 17007)

Singapore meeting outcome statement

Sydney meeting outcome statement

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