Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Sweden drafts proposals for classification of software-based IT systems

This article was originally published in SRA

Executive Summary

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...



Global Pharma Guidance Tracker – November 2020

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.

Global Medtech Guidance Tracker: November 2020

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.

Labeling Changes In Store For Hydroxychloroquine In EU After COVID-19 Experience

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.

UsernamePublicRestriction

Register

ID1132679

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel