Since May 2021, medical devices manufacturers operating and/or selling within the EU must comply with the EU MDR (EU 2017/745). The regulation’s objective is to improve patient safety by evaluating existing devices (e.g. through PMS and PMCF) and ensuring transparency throughout a device’s lifecycle.
One major new demand of the MDR (Annex II) is that manufacturers’ technical documentation must be presented in a “clear, organized, readily searchable and unambiguous manner”. Until now, many affected companies have been working with unstructured, inflexible data collection and sharing systems, such as paper, Excel or email. Since these systems are cost-inefficient, unsafe, and likely to struggle in the post-MDR era, we can expect a surge in companies moving their technical documentation into the cloud.
But the new regulation isn't the only reason for going digital with your technical documentation. Our infographic "Going Paperless in Clinical Trials" offers six reasons for moving trials and post-market surveillance into the cloud. Not only will this help you become MDR compliant, it also offers benefits such as:
We hope you will enjoy this Infographic! If you have any issues accessing it or any additional questions, please feel free to reach out to us at any time: