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.

IMDRF Documents

Clinical guidelines, regulatory resources, and compliance tools

115 resources

115 resources

Singapore meeting outcome statement

IMDRF Outcome statement IMDRF Documents

Outcome statement published by IMDRF.

IMDRF Documents

Singapore meeting outcome statement

France meeting outcome statement

Sydney meeting outcome statement

San Fransisco meeting outcome statement

Tokyo meeting outcome statement

Washington D.C meeting outcome statement

Brazil meeting outcome statement

Kyoto meeting outcome statement

Vancouver meeting outcome statement

Florianópolis meeting outcome statement

China meeting outcome statement

Moscow meeting outcome statement

China (Beijing) meeting outcome statement

Media statement – Successful Launch to the IMDRF

Ottawa, Canada meeting outcome statement

Brussels meeting outcome statement

IMDRF Chair and Secretariat rotates to Europe

IMDRF/MDSAP WG/N5: Regulatory Authority Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations

IMDRF/UDI WG/N7: UDI Guidance: Unique Device Identification (UDI) of Medical Devices

IMDRF/SaMD WG/N10: Software as a Medical Device (SaMD): Key Definitions

IMDRF/RPS WG/N20: Points to consider in the use of the IMDRF Table of Content for Medical Device Submissions pre-RPS

IMDRF/RPS WG/N21: RPS Beta Testing Document

IMDRF/MDSAP WG/N22: MDSAP: Overview of Auditing Organization Assessment and Recognition Decision Related Processes

IMDRF/Standards WG/N15: Standards WG: Final Report: 'List of international standards recognized by IMDRF management committee members' Current as of: March 2014

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