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...
USA – FDA drafts guidance on essential outputs for drug delivery devices
The US Food and Drug Administration (FDA) has issued a draft guidance to assist sponsors of drug-device combination products in developing “essential drug delivery...
UK – Medical devices: UK approved bodies
Approved bodies under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) for medical devices...
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)...
