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

56 resources

2020 ESC Guidelines on Sports Cardiology and Exercise in Patients with Cardiovascular Disease

Clinical Guideline 2020 Cardiology & Vascular European Guidelines

Clinical Guideline by ESC in Cardiology & Vascular (2020).

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2020 ESC Guidelines for the management of Adult Congenital Heart Disease

Clinical Guideline 2020 Cardiology & Vascular European Guidelines

Clinical Guideline by ESC in Cardiology & Vascular (2020).

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2019 ESC/EAS Guidelines for the management of dyslipidaemias

Clinical Guideline 2019 Cardiology & Vascular European Guidelines

Clinical Guideline by ESC in Cardiology & Vascular (2019).

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2019 ESC Guidelines on Supraventricular Tachycardia

Clinical Guideline 2019 Cardiology & Vascular European Guidelines

Clinical Guideline by ESC in Cardiology & Vascular (2019).

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2019 ESC Guidelines on Diagnosis and Management of Acute Pulmonary Embolism

Clinical Guideline 2019 Cardiology & Vascular European Guidelines

Clinical Guideline by ESC in Cardiology & Vascular (2019).

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2018 ESC/EACTS Guidelines on Myocardial Revascularisation

Clinical Guideline 2018 Cardiology & Vascular European Guidelines

Clinical Guideline by ESC in Cardiology & Vascular (2018).

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2018 ESC/EACTS Fourth Universal Definition of Myocardial Infarction

Clinical Guideline 2018 Cardiology & Vascular European Guidelines

Clinical Guideline by ESC in Cardiology & Vascular (2018).

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2018 ESC Guidelines for Diagnosis and Management of Syncope

Clinical Guideline 2018 Cardiology & Vascular European Guidelines

Clinical Guideline by ESC in Cardiology & Vascular (2018).

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21 CFR Part 803 — Medical Device Reporting (MDR)

Regulation 2024-01-01 Regulations US (FDA)

Mandatory reporting for incidents where a device may have caused or contributed to death or serious injury. Applies to manufacturers, importers, and device user facilities.

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21 CFR Part 801 — Device Labeling

Regulation 2024-01-01 Regulations US (FDA)

Covers all labeling requirements for medical devices including labels affixed to the device and all descriptive and informational literature that accompanies it.

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Regulatory Resources

2020 ESC Guidelines on Sports Cardiology and Exercise in Patients with Cardiovascular Disease

2020 ESC Guidelines for the management of Adult Congenital Heart Disease

2019 ESC/EAS Guidelines for the management of dyslipidaemias

2019 ESC Guidelines on Supraventricular Tachycardia

2019 ESC Guidelines on Diagnosis and Management of Acute Pulmonary Embolism

2018 ESC/EACTS Guidelines on Myocardial Revascularisation

2018 ESC/EACTS Fourth Universal Definition of Myocardial Infarction

2018 ESC Guidelines for Diagnosis and Management of Syncope

21 CFR Part 803 — Medical Device Reporting (MDR)

21 CFR Part 801 — Device Labeling

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