What is IVD software?

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.