Regulatory Resources

Clinical guidelines, MDCG guidance, FDA guidance, standards, and compliance tools

Home/Resources
All Categories
American Guidelines 221 Annex XVI Products 3 Borderline and Classification 5 Brazil (ANVISA) 1 Cardiology & Vascular 19 Cardiology & Vascular 47 China (NMPA) 1 Class I Devices 1 Clinical Investigation and Evaluation 17 Dermatology & Venereology 12 Dermatology & Venereology 7 Endocrinology, Diabetes & Metabolism 19 Endocrinology, Diabetes & Metabolism 20 EU 3 EU Regulation 2 EUDAMED 2 European Guidelines 510 Eye, ENT & Neurosensory 5 Eye, ENT & Neurosensory 7 FDA Guidance 106 Gastroenterology & Hepatology 40 Gastroenterology & Hepatology 47 Imaging & Radiology 6 Imaging & Radiology 5 IMDRF Documents 115 India (CDSCO) 1 Infectious Diseases & Microbiology 31 Infectious Diseases & Microbiology 13 Internal Medicine & Emergency 14 Internal Medicine & Emergency 4 IVDR 2 Japan (PMDA) 1 MDCG Guidance 54 MDR 8 Medical Guidelines & Recommendations 731 Medical Technology & Engineering 0 Medical Technology & Engineering 0 NB White Papers 15 Neurology & Neurosurgery 56 Neurology & Neurosurgery 12 New Technologies 7 Notified Bodies 4 Oncology & Haematology 74 Oncology & Haematology 33 Other / Transition 5 Paediatrics 16 Paediatrics 6 Post-Market Surveillance and Vigilance 5 Public Health & Primary Care 39 Public Health & Primary Care 8 Regulations 17 Rehabilitation & Geriatrics 4 Rehabilitation & Geriatrics 15 Respiratory & Intensive Care 29 Respiratory & Intensive Care 8 Rheumatology & Immunology 29 Rheumatology & Immunology 11 South Korea (MFDS) 1 Standards 51 Surgery & Orthopaedics 5 Surgery & Orthopaedics 30 Team NB Documents 50 UDI 4 UK (MHRA) 1 Umbrella & Cross-Cutting 8 Umbrella & Cross-Cutting 0 US (FDA) 8 Women's Health & Obstetrics 33 Women's Health & Obstetrics 12
115 resources

IMDRF/GRRP WG/N47 FINAL:2024 (Edition 2): Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices

IMDRF Technical document 2024-04-26 IMDRF Documents

Technical document published 2024 by IMDRF.

Download PDF

IMDRF/GRRP WG/N40 FINAL:2024 (Edition 2): Competence, Training, and Conduct Requirements for Regulatory Reviewers

IMDRF Technical document 2024-04-26 IMDRF Documents

Technical document published 2024 by IMDRF.

Download PDF

IMDRF/GRRP WG/N59 FINAL:2024 (Edition 2): Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews

IMDRF Technical document 2024-04-26 IMDRF Documents

Technical document published 2024 by IMDRF.

Download PDF

IMDRF/GRRP WG/N52 FINAL:2024 (Edition 2): Principles of Labelling for Medical Devices and IVD Medical Devices

IMDRF Technical document 2024-04-26 IMDRF Documents

Technical document published 2024 by IMDRF.

Download PDF

IMDRF/GRRP WG/N61 FINAL:2024 (Edition 2): Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews

IMDRF Technical document 2024-04-26 IMDRF Documents

Technical document published 2024 by IMDRF.

Download PDF

IMDRF/GRRP WG/N66 FINAL:2024 (Edition 2): Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews

IMDRF Technical document 2024-04-26 IMDRF Documents

Technical document published 2024 by IMDRF.

Download PDF

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.

Download PDF

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

IMDRF Procedural document 2024-05-20 IMDRF Documents

Procedural document published 2024 by IMDRF.

Download PDF

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

IMDRF Information document 2024-05-03 IMDRF Documents

Information document published 2024 by IMDRF.

Download PDF

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

IMDRF Technical document 2024-06-25 IMDRF Documents

Technical document published 2024 by IMDRF.

Download PDF
Loading more resources…

Medical Device Navigator

The comprehensive free database for medical device companies, FDA-cleared devices, EU Notified Bodies, competent authorities, clinical guidelines, and regulatory resources worldwide - 4,975 companies · 5,064 devices · 53 EU Notified Bodies · 1,129 resources & guidelines. Founded by Dr. Hatem Rabeh (MD, MSc Ing).

Directory

Company

Content

© 2026 Medical Device Navigator. All rights reserved. Privacy Policy Terms Cookies Take Down Policy
Scroll to Top