medicines-medical devices-medtech-regulatory affairs
medicines-medical devices-medtech-regulatory affairs
The Medical Device Coordination Group (MDCG) has published the following updates: MDCG number Notes MDCG 2021-24 Guidance on classification of medical devicesThe purpose of this chapter is to provide a general overview on the impact of the classification of medical…
Last updated: 16 October 2021 See section on updates at the end of the post. The importance of Article 117 of the MDR, for Drug-Device Combination (DDC) products should not be underestimated. Anyone in regulatory affairs working on Drug-Device combination…
TGA, Australia has published guidance on the imminent reclassification of certain medical devices. Which medical devices are going to be reclassified? The following medical devices are going to be reclassified: Medical devices in direct contact with the heart, central circulatory…
The UK MHRA is updating regulations applying to software and artificial intelligence (AI) as a medical device. The exciting and fast developing field of software and artificial intelligence (AI) as a medical device has an increasingly prominent role within health…
The UK MHRA is consulting on the future regulation of medical devices in the UK. Powers in the Medicines and Medical Devices Act (2021) allow the MHRA to amend the Medical Devices Regulations 2002 which govern medical devices regulation in…
A new, sensitive COVID-19 test produces sample-to-signal in under ten minutes. Researchers from the University of Birmingham have confirmed the speed, accuracy and simplicity of a novel, highly sensitive testing method for COVID-19 that can be deployed at entertainment venues,…
The TGA. Australia has provided further information on the reclassification of of software based medical devices. Recent changes to regulation of software based medical devices The regulatory changes came into effect on 25 February 2021 as previously reported in this…
The Medical Devices Branch (MDB) of the Health Sciences Authority (HSA) Singapore, has recently released a draft regulatory guideline for the classification of Standalone Medical mobile applications (commonly referred to as Software as a Medical Device (SaMD)) and Qualification of…
The European Medicines Agency (EMA) has adopted a guideline on quality documentation for medicinal products when used with a medical device. The guideline was adopted on 22 July 2021 and will come into effect on 1 January 2022. What is…
The TGA, Australia has published guidance for developers and users of software to decide which software and apps are medical devices. The flowcharts in the guidance document show which software products are regulated as a medical device and which are…