Sweden drafts proposals for classification of software-based IT systems
This article was originally published in SRA
A Swedish Medical Products Agency working group has issued recommendations for framing guidance on the classification of software-based healthcare information systems as a medical device1,2.
You may also be interested in...
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Twenty-four guidance documents have been posted on the tracker since its last update.
The risk of psychiatric disorders with chloroquine and hydroxychloroquine-containing medicines received renewed attention in the EU after they were being used as potential treatments for COVID-19.