How To Navigate Clinical Data Per EU MDR
By Matthias Fink, MD, TÜV SÜD America
In May 2017, the European Medical Devices Regulation (MDR) 2017/745 was published to replace the current Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD). In April 2020, the European Parliament adopted the European Commission’s proposal to postpone the Date of Application (DoA) of the MDR by one year, and as such, the new DoA is May 26, 2021. It is worth noting that the end of the transition period for MDD and AIMDD certificates remains May 26, 2024, thus reducing the timeline for manufacturers to get their MDR certificates from four to three years.
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March 9, 2021
- CA US
Compliance4All
Phone:8004479407
Overview:
This session will provide insights on moving from the traditional regulatory strategies for mature technologies to the new regulatory strategies for novel uses of AI and ML while engaging FDA and/or Notified Bodies in the effort. The IMDRF, US and EU perspectives on what s next for AI and ML as SaMD will be explored.
Why you should Attend: This session will engage professionals looking to understand the regulatory challenges of software as a medical device (SaMD) with special focus on AI/Machine Learning (ML).
Areas Covered in the Session:
Describe actual and future AI applications that are changing patient treatment and healthcare delivery through the exploration of real-world examples (across different diagnostic/therapeutic and technology areas)
Sunday, February 28, 2021
Regulation 2020/561 (Regulation) was passed by the EU in April last year to take account of issues raised by the COVID-19 pandemic and to defer the date of application of certain provisions of Regulation 2017/745 (MDR) by one year.
The Regulation was published on 24 April 2020 through an EU accelerated procedure, and although the COVID-19 pandemic is still a major issue, the expiry of the one-year deferral is fast approaching.
The Regulation recognised that the COVID-19 outbreak and the associated public health crisis presented an unprecedented challenge to EU member states and constituted an immense burden for national authorities, health institutions, Union citizens and economic operators. Further, it recognised that the public health crisis created extraordinary circumstances that demand substantial additional resources, as well as an increased availability of vitally important medical devices, that could not reasonably have been anticipated