Before jumping headfirst into the complexity of the Medical Device Regulation, you must be 100% sure that it is worth it. This assessment can be complex if you sell health-related software in the European Union, as the boundaries between device categories remain unclear.
The focus is on the qualification of a device as a Medical Device Software (MDSW) or an In Vitro Diagnostic Medical Device Software (IVD MDSW), which both fall under the EU MDR or IVDR.
Can the software be considered as a medical device software ?
First of all, the software must fulfill the definition of the medical device and/or of the in Vitro medical device to be qualified as a MDSW. Moreover, it must have a medical purpose on its own and be intended to drive/influence the use of a (hardware) medical device, used alone, or in combination, for a specific purpose.
A MDSW is a software that provides informations on…
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
- control or support of conception;
- products specifically intended for the cleaning, disinfection or sterilization of devices as referred to in Article 1(4) and Annex XVI products.
An IVD MDSW is a MDSW which provides information…
- concerning a physiological or pathological process or state (by investigation of this process or state); or
- concerning congenital physical or mental impairments
- concerning the predisposition to a medical condition or a disease;
- to determine the safety and compatibility with potential recipients;
- to predict treatment response or reactions;
- to define or monitoring therapeutic measures.
In a former guidance, the MDCG additionally defined this term as a set of instructions that processes input data (provided through the use of a human data-input device) and creates output data (produced by a software).
Is the medical device software covered by the MDR or IVDR ?
In March 2021 the MDCG published an infographie on this topic. It describes the decision steps to assist qualification of MDSW.
Quick overview concerning the FDA:
The term “Software as a Medical Device (SaMD)” is defined by the IMDRF as a “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”. The FDA published several guidances on the requirements for the SaMD, here are some:
- Clinical Decision Support Software
- Guidance for Industry and Food and Drug Administration Staff
- Draft Guidance for Industry and Food and Drug Administration Staff
- Federal Register NoticeExternal Link Disclaimer on “Prescription Drug-Use- Related Software”