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

IEC 62304:2006/AMD1:2015 — Medical device software — Software life cycle processes

IEC Standard 2015-06-01 Standards

Download PDF

ISO/TR 24971:2020 — Medical devices — Guidance on the application of ISO 14971

ISO Technical Report 2020-06-01 Standards

Download PDF

ISO 14971:2019 — Medical devices — Application of risk management to medical devices

ISO Standard 2019-12-01 Standards

Download PDF

ISO 13485:2016 — Medical devices — Quality management systems — Requirements for regulatory purposes

ISO Standard 2016-03-01 Standards

Download PDF

Presenting Risk Information in Prescription Drug and Medical Device Promotion

FDA Guidance 2009-05-01 FDA Guidance

Draft FDA guidance on labeling. Published 2009 by CDRH/CBER.

Download PDF

Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development

FDA Guidance 2016-02-01 FDA Guidance

Final FDA guidance on human factors. Published 2016 by CDRH/CBER.

Download PDF

Modifications to Devices Subject to Premarket Approval (PMA) — PMA Supplement Decision-Making Process

FDA Guidance 2008-12-01 FDA Guidance

Final FDA guidance on pma. Published 2008 by CDRH/CBER.

Download PDF

Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials

FDA Guidance 2010-02-01 FDA Guidance

Final FDA guidance on clinical evidence. Published 2010 by CDRH/CBER.

Download PDF

Humanitarian Use Device (HUD) Designations

FDA Guidance 2013-01-01 FDA Guidance

Final FDA guidance on hde. Published 2013 by CDRH/CBER.

Download PDF

Medical Device Classification Product Codes

FDA Guidance 2013-04-01 FDA Guidance

Final FDA guidance on classification. Published 2013 by CDRH/CBER.

Download PDF

Loading more resources…

Regulatory Resources

IEC 62304:2006/AMD1:2015 — Medical device software — Software life cycle processes

ISO/TR 24971:2020 — Medical devices — Guidance on the application of ISO 14971

ISO 14971:2019 — Medical devices — Application of risk management to medical devices

ISO 13485:2016 — Medical devices — Quality management systems — Requirements for regulatory purposes

Presenting Risk Information in Prescription Drug and Medical Device Promotion

Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development

Modifications to Devices Subject to Premarket Approval (PMA) — PMA Supplement Decision-Making Process

Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials

Humanitarian Use Device (HUD) Designations

Medical Device Classification Product Codes

Medical Device Navigator

Directory

Company

Content