On the 3rd of August, we had a great and fruitful session about the medical device regulatory landscape presented by Tobias Schreiegg, from Siemens Healthineers. These two webinars are part of the same session within the acceleration programme in which the solutions selected (#GameChangers) for OC#1 are participating.
Within those webinars, the HCR regulations were covered.
Some of the topics Schreiegg addressed were: – What is a medical device? – How to get requirements: Laws and standards – Harmonized standards – General Safety and Performance Requirements Annex I, MDR – Specific Requirements – Scan pre- and postmarket databases – Clinical claim vs. Technical claim – Conceptually claiming clinical benefit is a clinical claim – Article 10, MDR – Conformity Assessment PathsIndirect risk – Is artificial intelligence covered by the term „software“? – 21st Century Cures Act: Speed-up market access & Support new technologies for better health care – Digital Health Program and 21st Century Cures Act De-regulation of software, etc.