Europe – MDCG 2024-10 Clinical evaluation of orphan medical devices
The level of clinical evidence that is required to place medical devices on the market has been increased by the MDR, including an increased...
Switzerland – Swissmedic prepares medtech industry for activation of medical devices database module
The first module of the swissdamed medical devices database goes online in August
Since the MRA with the EU has not been updated, Swissmedic does...
Europe – Health Technology Assessment : Guidance on reporting requirements for multiplicity issues and...
This guidance describes how to deal in practice with multiplicity issues and
complementary analyses (like specific subgroup analyses, specific post hoc analyses and sensitivity analyses)...
Europe – Health Technology Assessment : Guidance on outcomes for joint clinical assessments
Clinical outcome assessments (COAs), used in clinical studies (whether they are interventional (also called experimental), or observational), are a key component of health technology...
Europe – Phthalates in certain medical devices: updated SCHEER guidelines published
Today, following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) provided the update of their guidelines on...
Australia – Medical device regulation changes
Changes have been made to the regulation of:
software-based medical devices
prescription spectacle lenses
medical devices containing microbial, recombinant, or animal substances
medical device...
France – Le Grand Défi « Dispositifs médicaux numériques en santé mentale »
La méthodologie d’élaboration du plan d’actions du Grand Défi a permis de faire émerger un ensemble de propositions d’actions suite à l’audition de 153 acteurs et...
Europe – Update – MDCG 2022-13 Rev.1 – Designation, re-assessment and notification of conformity...
This document aims to provide guidance to the authorities responsible for notified
bodies (hereafter, the Designating Authorities) and joint assessment teams (JATs)
when conducting:
− assessments of...
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...
Europe – MDCG 2024-1-5 : Guidance on the vigilance system for CE-marked devices DSVG...
The aim of this Device Specific Vigilance Guidance (DSVG) is to harmonise vigilance
reporting and provide guidance for manufacturers of Urogynaecological Surgical
Mesh Implants used for...
