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

IMDRF/RPS WG/N50: Round 2, RPS Beta Testing Report

IMDRF Information document 2018-07-27 IMDRF Documents

Information document published 2018 by IMDRF.

IMDRF Documents

IMDRF/RPS WG/N50: Round 2, RPS Beta Testing Report

IMDRF/RPS WG/N27 FINAL:2019: Assembly and Technical Guide for IMDRF Table of Contents Submissions

IMDRF/Standards WG/N51: Optimizing Standards for Regulatory Use

IMDRF/RPS WG/N27: Assembly and Technical Guide for IMDRF Table of Contents Submissions (Archived)

IMDRF/UDI WG/N54: System requirements related to use of UDI in healthcare including selected use cases

IMDRF/UDI WG/N53: Use of UDI Data Elements across different IMDRF Jurisdictions

IMDRF RPS Communication – 24 January 2019: IMDRF RPS Communication – 24 January 2019

IMDRF/UDI WG/N48: Unique Device Identification system (UDI system) Application Guide

IMDRF MDCE WG/N55: Clinical Evidence – Key Definitions and Concepts

Russia Yekaterinburg meeting outcome statement

IMDRF MDCE WG/N56: Clinical Evaluation

Closed session management committee meeting outcome statement

IMDRF MDCE WG/N57: Clinical Investigation

IMDRF/CYBER WG/N60: Principles and Practices for Medical Device Cybersecurity

IMDRF/AE WG/N44: Maintenance of IMDRF AE Terminologies

Singapore Virtual Meeting outcome statement

Korea Virtual Meeting outcome statement

IMDRF/IVD WG/N64: Principles of In Vitro Diagnostic (IVD) Medical Devices Classification

IMDRF/MDSAP WG/N6: Regulatory Authority Assessor Competence and Training Requirements

IMDRF/MDCE WG/N65: Post-Market Clinical Follow-Up Studies

IMDRF/MDSAP WG/N11: MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization

IMDRF/MDSAP WG/N4: Competence and Training Requirements for Auditing Organizations

Korea Virtual Meeting outcome statement

IMDRF/Standards WG/N72 (Edition 1): IMDRF Standards Liaison Program Framework

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