Standards, Guidance & Notices
Showing 31–40 of 128
EU
MDCG
MDCG
MDCG 2024-16
Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices
MDCG 2024-16 — Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices — (December 2024)
Published: 2024-12-01
EU
MDCG
MDCG
MDCG 2024-15
Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED
MDCG 2024-15 — Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED — (November 2024)
Published: 2024-11-01
EU
MDCG
MDCG
MDCG 2021-25 rev.1
Application of MDR requirements to " legacy devices " and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC
MDCG 2021-25 rev.1 — Application of MDR requirements to " legacy devices " and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC — (October 2024)
Published: 2024-10-01
JFMDA
Notice
Notice
jaame-well-known-matters-samd
SaMD Rebalance Notification (Phased Approval) Hypothetical Case Collection for Disease Diagnosis SaMD
September 24, 2024 publication by JFMDA's SaMD Regulatory Compliance Working Group providing illustrative case examples based on the phased approval framework for disease diagnosis software as medical devices.
Published: 2024-09-24
JFMDA
Notice
Notice
well-known-matters-chiken-anketo+report2024
Medical Device Clinical Trial Implementation Status Survey Results Report
September 4, 2024 survey report on medical device clinical trial implementation status in Japan, addressing historical challenges regarding high costs, delayed subject enrollment, and data quality concerns in the Japanese clinical trial environment.
Published: 2024-09-04
EU
MDCG
MDCG
MDCG 2021-4 rev.1
Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746
MDCG 2021-4 rev.1 — Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746 — (September 2024)
Published: 2024-09-01
EU
MDCG
MDCG
MDCG 2024-1-5
DSVG 05 on Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence
MDCG 2024-1-5 — DSVG 05 on Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence — (June 2024)
Published: 2024-06-01
JFMDA
Notice
Notice
jaame-committee-40
JFMDA 40th Anniversary Commemorative Project Dedicated Website
Website featuring JFMDA's 40th anniversary commemorative initiatives launched in February 2024, including digest videos and resources celebrating the organization's four decades of contribution to the medical device industry.
Published: 2024-05-07
EU
MDCG
MDCG
MDCG 2022-4 rev.2
Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD
MDCG 2022-4 rev.2 — Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD — (May 2024)
Published: 2024-05-01
NIST
CSWP
CSWP
CSWP 33
Product Development Cybersecurity Handbook: Concepts and Considerations for IoT Product Manufacturers
As interest in Internet of Things (IoT) technologies has grown, so have concerns and attention to cybersecurity of the newly network-connected products and services offered in many sectors, including energy services, water/waste-water services, automobiles, consumer electronics, and government. This Product Development Cybersecurity Handbook will describe concepts important to developing and deploying secure IoT products for any sector or use case, including discussion of IoT Product architecture, deployment, roles and cybersecurity perspectives. This publication extends and elaborates on NIST’s prior work related to development of IoT products. In addition to discussing the concepts, this publication also demonstrates their application and discusses how satisfaction of cybersecurity in IoT products can be approached.
Published: 2024-04-03
