medicines-medical devices-medtech-regulatory affairs
medicines-medical devices-medtech-regulatory affairs
The following commission implementing decisions on the harmonised standards for medical devices drafted in support of the Medical Devices Regulation (EU) 2017/745 (MDR) of the European Parliament and of the Council have been published thus far: Commission Implementing Decision (EU)…
Last updated: 10 January 2022 See all updated at the end of this post. Swissmedic has published guidance on the requirement for Swiss authorised representative (CH-REP) for medical devices. Definition of a Swiss authorised representative Natural or legal person in…
Hologic has launched its Artificial Intelligence (AI) based Genius Digital Diagnostics system in Europe, for cervical cancer screening. The burden of cervical cancer in Europe According to a study by the EPF in 2020: Current estimates indicate that every year, 61,072…
Last updated: 10 November 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…
The UK, US and Canadian regulators have identified ten guiding principles to be addressed when medical devices use Artificial Intelligence (AI) or machine learning software. AI and machine learning technologies have the potential to transform health care by deriving new…
The Medical Device Coordination Group (MDCG) has published the following updates: MDCG number Notes MDCG 2021-26 Questions and Answers on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746This document presents questions and answers…
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,…