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/GRRP WG/N63 FINAL:2024 (Edition 2): Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews

IMDRF Technical document 2024-04-26 IMDRF Documents

Technical document published 2024 by IMDRF.

IMDRF Documents

IMDRF/GRRP WG/N63 FINAL:2024 (Edition 2): Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews

IMDRF/MC/N83 FINAL: 2024: Slide Template for IMDRF Membership Application Presentations

IMDRF/MC/N82 FINAL:2024: IMDRF 25th Session Workshop: White Paper on Reliance

IMDRF/RPS WG/N13 Final:2024 (Edition 4): In Vitro Diagnostic Medical Device Regulatory Submission Table of Contents (IVD ToC)

IMDRF/MC/N84: IMDRF Document Implementation Report

IMDRF/RPS WG/N9 Final:2024 (Edition 4): Non-In Vitro Diagnostic Device Regulatory Submission Table of Contents (nIVD ToC)

IMDRF/AET WG/N85 FINAL: 2024: Common Data Set for Adverse Event Data Exchange Between IMDRF Regulators

IMDRF 26th MC Meeting Seattle, Washington September 2024 – Outcome Statement

IMDRF/SaMD WG/N81 FINAL:2025: Characterization Considerations for Medical Device Software and Software-Specific Risk

IMDRF/MC/N87: IMDRF 26th Session Workshop – White Paper on Developing a Regulatory Framework

IMDRF/AIML WG/N88 FINAL:2025: Good machine learning practice for medical device development: Guiding principles

IMDRF 27th MC Meeting Tokyo, Japan March 2025 – Outcome Statement

IMDRF/AE WG/N43: Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes

IMDRF/MC/N1: IMDRF Terms of Reference

IMDRF/NCAR WG/N14 FINAL:2025 (Edition 5): Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form

IMDRF/MC/N2: IMDRF Standard Operating Procedures

IMDRF 28th MC Meeting Sapporo, Japan September 2025 – Outcome Statement

IMDRF/MC/N84: IMDRF Document Implementation Report

IMDRF/MC/N91 FINAL:2025: IMDRF Strategic Plan 2026-2030

Medical Device Navigator

Directory

Company

Content