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  • EU MDR: How Will Europe’s New Device Regulation Affect Software?

EU MDR: How Will Europe’s New Device Regulation Affect Software?

29th August 2019

Medilink WM patron MasterControl provides an informative article, highlighting to industry that software must not be overlooked when considering MDR requirements and compliance.

When it comes to medical devices, the term software is certainly nothing new. Definitions and requirements for software in the EU have already been clearly laid out in the prior medical device regulation, the Medical Device Directive (MDD or 93/42/CEE).

But while it is now clear that MDR requirements will be considerably more stringent, especially in terms of monitoring, software will be no exception to the rule.

Click here to read the full article provided by MasterControl – where you can also request a free white paper on ‘Top 5 Medical Device Industry Trends in 2019’

Medilink WM offers businesses the opportunity to attend various regulatory workshops taking place over the next few months to help support the new compliance rules from May 2020. Find out more at https://www.medilinkwm.co.uk/events/

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