Europe – MDCG 2021-5 Rev. 1 : Guidance on standardisation for medical devices
The EU legislative framework on medical devices currently consists of two Regulations adopted and entered into force in 2017:
• Regulation (EU) 2017/745 on medical...
USA – Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological...
This guidance addresses key aspects of drug delivery performance information for devices, and combination products that include device constituent parts, intended for delivery of...
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...
