medicines-medical devices-medtech-regulatory affairs
medicines-medical devices-medtech-regulatory affairs
This post is an attempt to provide an information resource for Advance Therapy Medicinal Product (ATMPs) in the EU. The information provided is by no means exhaustive. Click on the ‘+’ sign next to each heading to access the information…
Lucida Medical’s AI based and CE marked prostate cancer detection software, Prostate Intelligence™ (Pi™) is to undergo a retrospective cohort validation study . In May 2021, Lucida Medical was granted a CE Mark for Prostate Intelligence™ (Pi™ ), its AI-machine…
The European Commission is conducting a targeted stakeholder consultation on the amendments to Commission Implementing Regulation (EU) 520/2012 on pharmacovigilance activities. About Commission Implementing Regulations A Commission Implementing Regulation is a legally binding act of the European Union. It is…
Title of guidance Type and level of guidance About the guidance What does the guidance not address ? Source FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Final FDA is issuing this…
TGA Australia has published its 2021-2022 business plan. The 19 page document is packed with a wide range of priorities and they include the following: Priority 1- Product regulation and safety Digital transformation The four-year digital transformation will deliver simpler,…
CMDh Minutes for the meeting on 22-23 June 2021 The minutes for the above meeting are now available here (24 page document) and the following items are included: 1. Brexit (pg 7) The CMDh discussed a topic included under 8.3…
This post is an attempt to provide an information resource for the Clinical Trials Regulation (EU) no 536/2014 (CTR). The information provided is by no means exhaustive. Click on the ‘+’ sign next to each heading to access the information…
The Medical Device Coordination Group (MDCG) has published the following updates: MDCG number Notes MDCG 2021- 23 Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746…
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…