By contrast software for general purposes even when used in a healthcare setting or software intended.
Software as a medical device eu mdr.
The new regulatory landscape on software medical devices that will apply under the new regulations regulation eu 2017 745 medical device regulation mdr and regulation eu 2017 756 in vitro diagnostic regulation ivdr as of 26 may 2020 and 26 may 2022 respectively has been somewhat clarified by new guidance published by the european commission s medical devices coordination group.
The new eu mdr with a mandatory compliance date of 26 may 2020 replaces the former medical device directive mdd and introduces new concepts definitions classification rules and procedural requirements for medical device software and particularly for software products currently regulated as class i medical devices in europe.
Medical devices need a ce conformité européenne marking in order to be placed on the market in the european economic area eea and switzerland.
Medical software that falls under the scope of the mdr is considered a medical device and needs ce marking.
Examples of software as a medical device samd i think you need to see some examples to really understand what is a samd.
She also noted that by eu mdr definition software in its own right when specifically intended by the manufacturer to be used for one or more medical purposes set out in the definition of a medical device does qualify as a medical device.
You may find this pdf copy of the eu mdr to be a helpful reference tool as it contains quick links to each section of the eu mdr.
More on the basics of ce marking in the eu can be found here.
This would always be the case if the software goes a long way beyond controlling the medical device.
The eu mdr will soon replace the mdd and goes into effect in may 2021 so we will focus on it in this article.
The european commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations.
The european commission s medical device coordination group mdcg on friday released guidance to help medical software manufacturers understand the criteria for the qualification of software under the new eu medical devices regulation mdr and in vitro diagnostic regulation ivdr.
If for example software for calculating contraindications was encapsulated in hardware rule 11 would still apply.
But it s still software for the medical device regulation eu ivdr 2017 746 and eu mdr 2017 745.
Samd software as a medical device is a complex area and over the course of the 26 years since the medical devices directive 93 42 ec was first enforced for devices to be sold in the eu market software development has advanced leaps and bounds.
The eu considered making rule 11 applicable to software in medical devices as well as for stand alone software.
