For software manufacturers that are interacting with the healthcare system, it is important to know if the software developed qualifies as a medical device. Software that is considered a medical device can be placed on the market or put into service only if it complies with the rules applicable to medical devices.
However, not all software used within healthcare is qualified as a medical device. This is why understanding the rules on the qualification of medical devices is important.
As Romania is a Member State of the European Union, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (“MDR”) is directly applicable in Romania.
The Romanian Government adopted, by Emergency Ordinance no. 46/2021 (“GEO 46/2021”), the measures establishing a framework for the implementation of the MDR.
Under the MDR, “medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
- 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,
- providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
- and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:
- devices for the control or support of conception;
- products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.”
Therefore, it can be observed that software must have a medical purpose on its own to be qualified as a medical device software. To this aim, the intended purpose as described by the manufacturer of the software is relevant.
If the software does not fall within the definition of medical devices, it might be intended as an accessory for a medical device or an in vitro diagnostic medical device. In such cases, the respective software still falls under the scope of MDR or, respectively, the Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (“IVDR”).
According to the MDR, an “‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);”.
Under the IVDR, also directly applicable in Romania, “in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:
- concerning a physiological or pathological process or state;
- 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.”
There are also implementing and classification rules in the MDR that indicate certain software that is considered a medical device. As such, it is considered a medical device:
- the software that drives a device or influences the use of a device
- the software that is intended to provide information which is used to take decisions with diagnosis or therapeutic purposes
- the software intended to monitor physiological processes.
For cases where it is hard to draw a line between mere software and medical devices, there is a Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR („Software Qualification Guidelines“), endorsed by the Medical Device Coordination Group (MDCG) within the European Union, but which is not legally binding. However, it sets out orientations and examples to help qualify the software as a medical device.
For example, according to the Software Qualification Guidelines:
- are not medical devices in themselves: hospital information systems (that support the process of patient management); information systems that are intended only to transfer, store, convert, format, archive data; communication systems that are normally based on software for general purposes; Image Management System only used for viewing, archiving and transmitting images; Software intended for archiving patient results or for transferring results obtained from in vitro diagnostic medical devices from the home environment to the healthcare provider;
- are medical devices: decision support software; software module generating alarms based on the monitoring and analysis of patient specific physiological parameters; telesurgery systems; modules that are intended to influence the surgery procedure, modules that are intended to monitor the medical performance of medical devices; modules whose intended purpose is to assess the criticality of tests required and to perform automatic reprioritisation of the order based on patient data.
Other examples of qualification of software as a medical device can be found in the Manual on Borderline and Classification in the Community Regulatory Framework For Medical Devices (europa.eu).
According to the Software Qualification Guidelines, the following decision steps should be taken for qualification of software as a medical device:
- Assess if the product is a software.
- Assess if the product is an MDR Annex XVI device (products without an intended medical purpose that are listed in Annex XVI), or an accessory for a medical device, or a software driving or influencing the use of a medical device. If affirmative, then it must be considered as part of that device in its regulatory process or independently if it is an accessory, and the MDR or the IVDR is applicable. If it is not, step 3 must be followed.
- Assess if the software does perform an action on data, or performs an action beyond storage, archival, communication, simple search, lossless compression (i.e., using a compression procedure that allows the exact reconstruction of the original data) then it may be a medical device software. If not, then the MDR or the IVDR is not applicable. If yes, step 4 must be followed.
- Assess if the action is for the benefit of individual patients. If not, then the MDR or the IVDR is not applicable. If yes, step 5 must be followed.
- Assess if the software is a medical device software according to the Software Qualification Guidelines. If yes, then the MDR or the IVDR is applicable.
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