The advancements in technology and digital revolution of the healthcare and medical device industry have created a vast amount of technical solutions, software applications and other software being used for medical purposes. The legal framework regulating medical devices hasn’t kept up with the rapid movement and advancements in technology, creating an urgent need for updated regulations, covering critical aspects of development, classification and security of medical device software. The solution on the EU-market was presented in the Regulation (EU) 2017/745 –Medical Devices Regulation (“MDR”), with its date of application on May 26, 2021. The upcoming MDR brings changes to concepts, definitions and procedural requirements which affect all players in the medical device industry, particularly the manufacturers of medical device software. This white paper is intended to provide a brief overview of the key impact of the MDR on medical device software (“MDSW”). A follow-up white paper will be published during the summer in which clinical evidence requirements for MDSW and related topics will be discussed in detail.
Under the Medical Device Directive (“MDD”), software is considered a medical device if the intended use falls within the scope of the directive, meaning that the software is intended to be used for a medical purpose. The definition of a medical device is more or less maintained with the introduction of the MDR but with some important clarifications and extensions of the scope.
The EU medical device definition has contained the term ‘software’ since 2009, when it was incorporated following pressure from the Swedish Medical Products Agency. In an attempt to achieve international harmonization on what software is to be considered as a medical device, the International Medical Device Regulators Forum (IMDRF) introduced the phrase ‘software as a medical device’ (“SaMD”), which is defined as ‘software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device’. If a hardware medical device needs software to achieve its intended purpose, the software is not SaMD but rather a part of the hardware medical device. The U.S. Food and Drug Administration (FDA) has adopted the term SaMD, whilst in the EU the term ‘medical device software’ is used instead. The main reason for this is that in the EU, both software that fullfils a medical intended purpose and software intended to drive or influence the use of a hardware medical device is now regulated as MDSW under the MDR. Accordingly, it shall be noted that the term “stand alone software”, which was used in the MDD, is no longer used in the MDR. The rationale for the change is that software should be qualified and classified solely based on its intended purpose, regardless of its location.
SaMD= software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device (definition introduced by IMDRF and mainly used in the US and previously used under MDD)
MDSW= software that is intended to be used, alone or in combination, that fullfils a medical intended purpose and software intended to drive or influence the use of a hardware medical device (definition used in EU under MDR)
Read our latest white paper to get an overview of the impact of MDR on medical device software: MEDICAL DEVICE SOFTWARE – Understanding the impact of the MDR
In the summer there’ll be a follow-up white paper digging into the details of clinical evidence for medical device software.
This white paper is the third in a series published by Clarvin AB, Morris Law, Kickfile and Devicia AB – Your Medical Device CRO. Now in collaboration with SwedenBIO, the national association for the life science industry in Sweden, which Devicia AB – Your Medical Device CRO and Kickfile are proud new members of.
Åsa Runnäs, Sara Berglund Jonsson, Nicole Kvist, Siri Mårtensson Hjälmberg, Karin Odkrans, Malin Levin, Julia Edman, Nicole Hanzon, Helena Strigård, Frida Lawenius, Sofia Nordgren, Elisabeth Liljensten, Sara Nilsson, Amanda Lantz