TÜV SÜD MDR Interpretation: Is Article 23 paragraph 2 of the MDR applicable to software?

TÜV SÜD MDR Interpretation: Is Article 23 paragraph 2 of the MDR applicable to software?

Software manufacturers would like to know if Article 23 paragraph 2 is applicable to their devices. If we look at this Article, we can split it into two paragraphs, paragraph 1 and paragraph2. Paragraph 2 is applicable to hardware as well as software. Paragraph 1, due to the fact that it refers to “defective or worn”, can be just applicable to hardware.

Tuv Sud,MDR,Tüv Süd,Medical Device Regulation,Medical Devices,Notified Body,software,Software update,