Masterarbeit

The new aspects and changes of the Medical Device Regulation on classification of Medical devices with focus on software

Moritz Hass (2019)

Summary
Language: English
This master thesis provides an overview of the regulatory legislation for software as a medical device and of the changes resulting from the new Medical Device Regulation (MDR). For this purpose, the legislation before the entry into force of MDR is first presented. It then explains basic requirements for medical devices and related directives, followed by an elucidation of the conformity assessment procedures and the CE certification.
Next, the Medical Device Directive (MDD) and the In-Vitro Diagnostica Directive were highlighted in terms of software and its classification.
Based on these remarks, the thesis compares the new MDR requirements for software, especially rule 11, with the old legislation. The thesis shows which changes result from the new legislation for software classification and thus for the conformity assessment procedures.
In the end, the text deals critically with the new MDR in terms of software. Possible consequences of the new tightened requirements for software are presented and given food for thought for a future revision.
Pages: 40, Annexes: pages : 0