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

51 resources

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

ISO Standard 2019-12-01 Standards

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

ISO Technical Report 2020-06-01 Standards

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

ISO Standard 2016-03-01 Standards

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Regulatory Resources

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

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

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

Intertek — Usability Engineering for Medical Devices: IEC 62366

Eurofins — Extractables and Leachables Testing for Medical Devices

SGS — Biocompatibility and Chemical Characterization for Medical Devices

Dekra — Quality Management System for Medical Devices: ISO 13485:2016

TÜV SÜD — Biocompatibility Testing for Medical Devices: ISO 10993 Guide

TÜV SÜD — Cybersecurity for Connected Medical Devices: IEC 81001-5-1

TÜV Rheinland — Risk Management for Medical Devices: ISO 14971:2019

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