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To embed, copy and paste the code into your website or blog: After having dealt with the issue when software may be considered a medical device according to its intended purpose (in part 2) and the implications of the new risk classification regime (in part 3), in this part 4 of our series on Software as a Medical Device in Europe, we will now explore key changes to the quality assurance and documentation requirements for stand-alone medical device software (“ MDR”). INTRODUCTION: A NEW LIFE CYCLE-FOCUSED APPROACH MDD”) primarily focusses on the pre-approval stage of a medical device...

Having shed light on the relevance of the intended purpose of a medical device when determining whether software qualifies as medical devices software (“ MDSW”) under the new EU Medical Device Regulation 2017/745 (“ MDR”) in part 2 of our series of articles, in this part 3, we now turn to the issue of risk classification of such MDSW under the MDR. INTRODUCTION MDD”), most stand-alone MDSW ( i.e., MDSW not implemented in a more complex medical device, such as control software) including, for instance, a mobile app that allows users to take pictures of moles on their skin and evalua...

In Part 2 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will soon govern medical devices...

ISO 14971:2019 — Clarifying Benefit, Risk, & Benefit-Risk This is the third in a series of articles on the changes in the medical device risk management standard ISO 14971 that were released in December of 2019 and supported by guidance in the ISO TR 24971:2020 technical report or guidance on the medical device risk management standard. The standard and the technical report were reorganized and clarifications of the concepts of medical device risk management were included in the two documents. Few changes in the process resulted, but this article covers the change in the process for ben...

Share this article NEWTOWN, Pa., Jan. 28, 2021 /PRNewswire/ -- Micro Interventional Devices, Inc.™ (MID) announced today that it has submitted the required technical documentation for CE Mark approval for its MIA-T™ Percutaneous Tricuspid Annuloplasty System for tricuspid valve repair to its Notified Body. The receipt of a CE Mark would allow MID to commercialize MIA-T in the European Union in countries governed by the European Medical Device Regulations (MDR).  MID is anticipating an approval in 2021.  This will enable a treatment option for millions of patients currently at too high...