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

1,129 resources

21 CFR Part 812 — Investigational Device Exemption (IDE)

Regulation 2024-01-01 Regulations US (FDA)

Allows investigational devices to be used in clinical studies to collect safety and effectiveness data in support of a PMA or 510(k) submission.

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21 CFR Part 814 — Premarket Approval (PMA)

Regulation 2024-01-01 Regulations US (FDA)

Governs the most stringent FDA device pathway, required for Class III high-risk devices. Requires valid scientific evidence of safety and effectiveness, including clinical data.

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21 CFR Part 807 Subpart E — Premarket Notification 510(k)

Regulation 2024-01-01 Regulations US (FDA)

Requires a 510(k) submission before commercial distribution of a device, demonstrating substantial equivalence to a legally marketed predicate device.

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21 CFR Part 807 — Establishment Registration and Device Listing

Regulation 2024-01-01 Regulations US (FDA)

Requires domestic and foreign manufacturers to register with FDA and list their devices annually. Foreign manufacturers must designate a US Agent.

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FD&C Act — Federal Food, Drug, and Cosmetic Act

Regulation 2024-01-01 Regulations US (FDA)

The foundational US law authorizing FDA to regulate medical devices. Sections 513–520 govern device classification, premarket review, postmarket requirements, and enforcement.

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EU AI Act — Regulation (EU) 2024/1689 — Official Full Text

Regulation 2024-08-01 EU Regulations

The EU AI Act (Regulation 2024/1689) establishes a harmonised legal framework for artificial intelligence in the EU, with key implications for AI-enabled medical devices under MDR and IVDR.

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