Software As A Medical Device Eu Mdr

The european commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations.

Software as a medical device eu mdr.

If for example software for calculating contraindications was encapsulated in hardware rule 11 would still apply. The eu mdr will soon replace the mdd and goes into effect in may 2021 so we will focus on it in this article. Annex viii chapter iii of the eu mdr. 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.

How medical device software and samd are classified in europe. 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. 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 eu considered making rule 11 applicable to software in medical devices as well as for stand alone software.

Examples of software as a medical device samd i think you need to see some examples to really understand what is a samd. 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. Medical software that falls under the scope of the mdr is considered a medical device and needs ce marking. Medical devices need a ce conformité européenne marking in order to be placed on the market in the european economic area eea and switzerland.

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. 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. Legally non binding guidance documents adopted by the medical device coordination group mdcg in accordance with article 105 of regulation 745 2017 pursue the objective of ensuring uniform application of the relevant provisions of the regulations within the eu.