Medical Device Software

Software that is intended for a medical purpose is classified as a medical device under the Medical Device Regulation (EU) 2017/745 (MDR) and In vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR).  

Medical software and medical apps (Software as a Medical Device (SaMD)) are growing in importance. To reflect this, the Regulations (MDR and IVDR) introduce new requirements for software which are detailed in MDCG guidance documents such as MDCG 2019-11, MDCG 2020-1. 

Software differs from other parts of medical devices in some fundamental ways. It is intangible and has a significant number of internal states, which make it highly complex; in addition software failures are system failures by definition. Dealing with these challenges requires different approaches (as opposed to hardware) with respect to the processes to be used during the development and to software maintenance, depending on whether the software is stand-alone or part of a medical device. 

This webinar session outlines most important aspects for Medical Device Software, including decision-making about whether a software is a medical device as well as correct classification, standards and guidance documents. 

Date and time: Monday, 17 May 2021, 4.30 pm (CEST)

Your speaker: Marco Caproni, Senior Product Specialist Software (MDA 0315) 

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