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
54 resources

MDCG 2024-5: Guidance on the Investigator’s Brochure content

MDCG Guidance 2024-04 Clinical Investigation and Evaluation MDCG Guidance
Download PDF

MDCG 2024-3: Guidance on content of the Clinical Investigation Plan

MDCG Guidance 2024-03 Clinical Investigation and Evaluation MDCG Guidance
Download PDF

MDCG 2024-15: Guidance on publication of clinical investigation reports in absence of EUDAMED

MDCG Guidance 2024-11 Clinical Investigation and Evaluation MDCG Guidance
Download PDF

MDCG 2024-10: Clinical evaluation of orphan medical devices

MDCG Guidance 2024-06 Clinical Investigation and Evaluation MDCG Guidance
Download PDF

MDCG 2019-15: Guidance notes for manufacturers of class I medical devices

MDCG Guidance 2019-12 Class I Devices MDCG Guidance
Download PDF

MDCG 2025-5: Q&A regarding performance studies of IVDs under Regulation 2017/746

MDCG Guidance 2025-06 Clinical Investigation and Evaluation MDCG Guidance
Download PDF

Helsinki Procedure: Helsinki Procedure for borderline and classification under MDR & IVDR

MDCG Guidance 2021-09 Borderline and Classification MDCG Guidance
Download PDF

MDCG 2022-5: Guidance on borderline between medical devices and medicinal products under MDR

MDCG Guidance 2024-10 Borderline and Classification MDCG Guidance
Download PDF

MDCG 2021-24: Guidance on classification of medical devices

MDCG Guidance 2021-10 Borderline and Classification MDCG Guidance
Download PDF

Manual on Borderline v4: Manual on borderline and classification under Regulations 2017/745 and 2017/746

MDCG Guidance 2025-09 Borderline and Classification MDCG Guidance
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