Back in Octo­ber, the Med­ical Device Coor­di­na­tion Group (MDCG) pub­lished MDCG 2023-4, Med­ical Device Soft­ware (MDSW) – Hard­ware com­bi­na­tions, Guid­ance on MDSW intend­ed to work in com­bi­na­tion with hard­ware or hard­ware com­po­nents.

Accord­ing to the scope state­ment of the doc­u­ment, the guid­ance “intends to exam­ine and pro­vide clar­i­fi­ca­tions on which spe­cif­ic reg­u­la­to­ry con­sid­er­a­tions apply when the hard­ware or hard­ware com­po­nent incor­po­rat­ing the data col­lec­tion ele­ment (cam­era, electrical/optical sen­sors etc.) are a med­ical device or an acces­so­ry to a med­ical device. [It] also out­lines sce­nar­ios where the hard­ware or hard­ware com­po­nent incor­po­rat­ing a data col­lec­tion ele­ment are not med­ical devices or acces­sories to a med­ical device.” mdi Europa will issue a ded­i­cat­ed arti­cle on that top­ic at a lat­er stage.

Del­e­gat­ed Reg­u­la­tion (EU) 2023/2197 has been pub­lished in the Offi­cial Jour­nal of the Euro­pean Union on Octo­ber 20. The reg­u­la­tion amends annex VI of the MDR. Man­u­fac­tur­ers may now assign a Mas­ter UDI-DI for con­tact lens­es of the same design para­me­ters where pre­vi­ous­ly indi­vid­ual UDI-DIs were required for dif­fer­ent con­tact lens vari­ants. The reg­u­la­tion enters into force the twen­ti­eth day after its pub­li­ca­tion. Man­u­fac­tur­ers may already now fol­low the act and it becomes oblig­a­tory as of Novem­ber 9, 2025. 

You can find the doc­u­ment in our library.

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website