What is IVD software?
By: Amy Eikelenboom – Co-Founder at NAALA
Published on 3 August, 2023
Amy Eikelenboom
Co-founder of NAALA
Published on 3 August 2023
Previously, we wrote about the difference between the MDR and IVDR. We also shared an infographic on Software as a Medical Device. But what if we told you that software can also be an in vitro diagnostic medical device? In this blog we touch upon the difference between MDR and IVDR Medical Device Software and usefull decision steps that can be used to aid the qualification.
What is an IVD software?
An in vitro diagnostic (IVD) medical device is any product intended by the manufacturer to be used in vitro for the testing of specimens.
- What does in vitro mean? In vitro is Latin for “within the glass”. If testing is performed in vitro, a test tube is used, for example. Unlike in vivo testing, it does not take place on or within a living organism but
outside of it. By the way, the original meaning “in the glass” does not
have to be taken so literally anymore: tests are now also performed in
other ways than in (glass) test tubes. Roughly speaking, it can be said
that when the test is performed outside the living organism, is in vitro - What does specimens mean? The word specimen also derives from Latin, in which it means as much as “sample”. Blood and tissue donations, derived from the human body, are
considered specimens in the IVDR.
In short: IVD medical devices are products that are intended to perform tests outside the
human body, for medical purposes, by means of (human) derivatives.
Can software be an IVD?
Software is explicitly mentioned in the definition of an IVD medical device in the IVDR:
“in vitro diagnostic medical device’ means any medical device which is a reagent, […], 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, […]” for the purpose of providing information on one or more of the following:
(a) concerning a physiological or pathological process or state;
(b) concerning congenital physical or mental impairments;
(c) concerning the predisposition to a medical condition or a disease;
(d) to determine the safety and compatibility with potential recipients;
(e) to predict treatment response or reactions;
(f) to define or monitoring therapeutic measures.
Software intended to be an accessory to an in vitro diagnostic medical device also meets the above definition and is subject to the same rules for demonstrating compliance.
Qualification of an IVD as Medical Device Software
MDCG 2019-11 provides valuable decision steps to aid the qualification of software as medical device software (”MDSW”). Not all software used within a healthcare setting qualifies as medical device software automatically. Generally speaking, there are two categories of software that qualify as in vitro diagnostic medical devices:
- Software that is intendepent of any other device (standalone software)
- Software that drives or influences the use of a device.
Software needed to make raw data from an in vitro diagnostic medical device readable to enable the use of the device for its intended purpose are considered to be software that drive or influence the use of the device. In both cases (standalone or embedded), the qualification of software as an in vitro diagnostic medical device is linked to its intended medical purpose and is not affected by the location or type of interconnection between the medical device and the software.
Ellaborating on the decision steps listed in the MDCG 2019-11 guidance, the following needs to be answered:
The EU has a set of rules, known as the Medical Devices Regulation (MDR), that govern the safety and effectiveness of medical devices sold in the EU. However, non-medical purpose products resembling medical devices are not covered by the MDR. Therefore, to ensure consumer safety, the EU has introduced a separate regulation for these products, commonly referred to as “annex XVI products.”
Does you product meet this definition? We will continue with question 2.
Devices listed in Annex XVI to the MDR are products that do not have an intended medical purpose but are still covered by the Regulations. As previously stated, software that is an accessory or drives or influences the use of a (hardware) medical device falls under the Medical Devices Regulations and is subject to the same rules as the product it drives or influences or is an accessory to.
Is your software not any of the above? We will continu with question 3.
As previously discussed, not all software used within a healthcare setting qualifies as MDSW. The following examples of software that do not qualify as MDSW can be derived from MDCG 2019-11:
- the retrieval of records by matching record metadata against record search criteria (i.e. simple search);
- the retrieval of information (e.g. library functions)
- altltering the representation of data for embellishment, cosmetic or compatibility purposes
- software intended for invoicing, staff planning and tasks such as e-mailing, web or voice messaging, data parsing, word processing, and back-up.
For software to qualify as MDSW, the action performed must meet the following two conditions:
- the software processes, analyses, creates or modifies medical information;
- that creation or modification of information is governed by a medical intended purpose.
For example:
- searching images for findings that support a clinical hypothesis as to the diagnosis or evaluation of therapy
- software which locally amplifies the contract of the finding on an image display so that it serves as a decision support or suggests an action to be taken by the user.
Does your software perform an action on data different from storage, archival, communication or simple search? We will continue with question 4.
To determine this, we can use the following examples of software which are not considered as being for the benefit or individual patients:
- the aggregation of populaton data,
- the provision of generic diagnostic or treatment pathways (not directed to individual patients),
- intended for scientific literature, medical atlases models and templates
- intended only for epidemiological studies or registers.
Does your software not fall under any of the above mentioned examples? If se, we will continue with question 5.
MDCG 2019-11 defines MDSW as “software that is intended to be used, alone or in combination, for a purpose as specified in the definition of a ‘medical devices’ in the medical devices regulation or in vitro diagnostic medical devices regulation.”
To determine whether we IVDR or the MDR applies, we use the following three decision steps:
To determine this, it must be researched for your specific product whether it provides information
(a) concerning a physiological or pathological process or state (by investigation of this process or state); or
(b) concerning congenital physical or mental impairments;
(c) concerning the predisposition to a medical condition or a disease;
(d) to determine the safety and compatibility with potential recipients;
(e) to predict treatment response or reactions;
(f) to define or monitoring therapeutic measures.
Examples of this are:
- MDSW that integrates genotype of multiple genes to predict risk a disease or medical condition developing or recurring;
- MDSW that uses an algorithm to characterise viral resistances to various drugs, based on a nucleotide sequence generated by genotyping assays. This software serves to generate new information (virus resistance profile) from available information on the genotype of the virus;
- MDSW intended to be used in microbiology for the identification of clinical isolates and/or the detection of antimicrobial resistances.
- A MDSW algorithm intended to provide information on the statistical predisposition for Down syndrome (Trisomy 21) and Edwards syndrome (Trisomy 18) in the first and second trimesters of pregnancy analyzing input data from various in vitro diagnostic medical device assays as well as, ultrasound measurements of the nasal bone or neck fold.
When your software provides information per the IVDR definition, it may qualify as In Vitro Diagnostic Medical Device Software (IVD MDSW). However, when it provides information on the following, it should be qualified as Medical Device Software (MD MDSW):
(a) diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
(b) diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
(c) investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
(d) control or support of conception;
(e) products specifically intended for the cleaning, disinfection or sterilization of devices as referred to in Article 1(4) and Annex XVI products.
In case the first question is answered affirmatively, we will continue with the next decision step.
When your software provides information based on data obtained solely from in vitro diagnostic medical devices, the software is an IVD MDSW. If the data analysed is obtained from a combination of both IVD medical devices and medical devices, 5.3 step must be answered.
If so, the IVDR applies to the MDSW. If not, the MDR applies to the MDSW.
In case the intended purpose of the MDSW output data fulfils both the medical devices and in vitro diagnostic medical device definitions set out in the MDR and IVDR, a weighting of the data sources based on the significance of the information in relation to fulfilling the intended purpose should be conducted to aid the manuacturer in determining which regulation to apply. MDCG 2019-11 suggests to take a qualitative approach to drive the weighting of data to assess the contribution of each data towards achieving the results.
Questions? We are happy to discuss your specific case.
Questions? We are happy to discuss your specific case.
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Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only. Changes in legal or regulatory requirements may occur at short notice, which we cannot reflect on a daily basis.
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