International – IMDRF Document Implementation Report – Final document
This report (30 August 2024) provides details on the status of various medical device regulations, as self-identified by IMDRF members. It covers documents on...
International – ISO/DIS 10993-1(en) Biological evaluation of medical devices — Part 1: Requirements and...
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried...
International – Lancement de la plateforme MeDevIS pour améliorer l’accès aux technologies et dispositifs...
L’Organisation mondiale de la Santé (OMS) annonce le lancement en ligne du Système d’information sur les dispositifs médicaux (MeDevIS), la première plateforme mondiale d’échange...
International – ISO/DIS 14155 will replace ISO 14155:2020
This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the...
International – 1SO 10933-1:2018 will be replaced by ISO/DIS 10993-1
Biological evaluation of medical devices
Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
This document specifies:
—...
International – IMDRF publishes AI/ML guiding principles echoing US, UK, Canadian regulators
The International Medical Device Regulators Forum (IMDRF) has published guiding principles for artificial intelligence/good machine learning (AI/ML) practices in medical device development that are...
International – FDA, Health Canada, MHRA release guiding principles on transparency for machine learning...
The US Food and Drug Administration (FDA), Health Canada, and the UK Medicines and Healthcare products Regulatory Agency (MHRA) have released additional guiding principles...
International – Assessment and Decision Process for the Recognition of a Conformity Assessment Body...
This document defines:
• the process and lifecycle for recognizing, maintaining, or ceasing recognition of a
CAB;
• the process of managing, grading, and closure of assessment...
International – Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies...
This document defines the content of the Regulatory Assessment Program and
provides guidance on the process-based assessment method. The Assessment
Program defines how Regulatory Authorities will...
International – Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device...
Standards perform a key role in the conformity assessment process; however, utilizing
existing standards for recognition of medical device CABs performing regulatory
reviews presents challenges. Regulatory...
