The reg­u­la­tion of med­ical device soft­ware (MDSW) is a chal­leng­ing area, in view of the numer­ous con­fig­u­ra­tions in which it can be used and how it inter­acts with hard­ware. Thus, the new guid­ance doc­u­ment, MDCG 2023-4, on MDSW meant to work in con­junc­tion with hard­ware com­po­nents which has been issued by the Euro­pean commission’s Med­ical Device Coor­di­na­tion Group (MDCG).

It is the inter­ac­tion between the MDSW, hard­ware or hard­ware com­po­nents, espe­cial­ly inte­grat­ed sen­sors, which brings into ques­tion the qual­i­fi­ca­tion and the cor­rect reg­u­la­to­ry path­way or con­for­mi­ty assess­ment of these hard­ware or hard­ware com­po­nents. The doc­u­ment looks at, and explains which par­tic­u­lar reg­u­la­to­ry fac­tors apply when the hard­ware or hard­ware com­po­nent incor­po­rat­ing the data col­lec­tion ele­ment, for exam­ple cam­era, is a med­ical device or an acces­so­ry to a med­ical device. 

The guid­ance also explains cir­cum­stances where the hard­ware or hard­ware com­po­nent incor­po­rat­ing a data col­lec­tion ele­ment are not med­ical devices or acces­sories to a med­ical device. 

The guid­ance includes a sec­tion explain­ing dif­fer­ent exam­ples of how MDSW and hard­ware, or hard­ware com­po­nent, func­tion in com­bi­na­tion to achieve a med­ical pur­pose and how they can be placed on the mar­ket. Hom­ing in on the case of exter­nal hard­ware com­po­nents deliv­er­ing input data to a MDSW app, the guid­ance exam­ines the reg­u­la­to­ry posi­tion of a sen­sor insert­ed in a der­mal patch, both where the man­u­fac­tur­er of the hard­ware com­po­nent and the MDSW app are the same indi­vid­ual and where they are dif­fer­ent peo­ple. After that, it goes into cas­es where the man­u­fac­tur­er of the hard­ware com­po­nent is incor­po­rat­ed with­in a smart­phone or wear­able con­nect­ed to a MDSW app or smart­phone or wearable.

In respect of reg­u­la­to­ry con­clu­sions, the guid­ance states that it is appar­ent that the MDSW, and the hard­ware or hard­ware com­po­nent, are inca­pable of achiev­ing a med­ical pur­pose on their own. For the soft­ware to be eli­gi­ble as a med­ical device, the man­u­fac­tur­er has to ascer­tain a med­ical pur­pose and accord­ing­ly present ver­i­fi­ca­tion that the said device abides by Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR). This means hav­ing to ver­i­fy, sub­stan­ti­ate and ascer­tain that the inter­ac­tion between the MDSW and the hard­ware, or hard­ware com­po­nent, pro­duces a valu­able, safe and well-per­form­ing MDSW. 

The guid­ance offers help­ful back­ground infor­ma­tion to grasp the con­text of its guid­ance, includ­ing an esti­ma­tion that about 25% of med­ical devices either incor­po­rate MDSW or are, in them­selves, MDSW. 

Source: Medtech Insight (an Infor­ma product)

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website