Britische MHRA veröffentlicht Leitlinien zu Software als Medizinprodukt

UK’s MHRA announced the Software and AI as a Medical Devices Change Programme last year to ensure regulatory requirements for software and AI are clear and patients are protected.

MHRA thinks that an inappropriate intended purpose statement can lead to non-compliance with the law and possible safety concerns and considering the emerging need of regulatory compliance in this area MHRA published the guidance on Software as a Medical Devices.

MHRA is trying to outline some common concerns with…