FDA 21 CFR Part 11 , the American Food and Drug Administration (FDA) specifies requirements for electronic documents, electronic signatures and handwritten signatures applied to electronic documents regarding trustworthiness, reliability, and equivalence to paper documents and handwritten signatures applied on paper. The requirements always apply, if information is created, changed, stored, transmitted or accessed electronically. If the documents generated, stored, transmitted or modified in this way serve to prove compliance with regulatory obligations, the requirements must be met. However, 21 CFR Part 11 is to be applied especially, if electronic records replace paper.
Medical Device Regulation (MDR) – Regulation 2017/745 (EU) on Medical Devices The German counterpart to the term “Medical Device Regulation” is “Medizinprodukteverordnung”. The regulation 2017/745