Medical Writing EU Regulations EU software regulations: The new normal or innovation stagnation?

Volume 29, Issue 3 - EU Regulations

EU software regulations: The new normal or innovation stagnation?


Advances in software and its application in a medical device and as a medical device have opened the door for many new technological capabilities in healthcare. Around the globe, government agencies have begun to take a heightened interest in how these devices are regulated. Whether it is software embedded in a medical device, software as a medical device, mobile medical applications, or artificial intelligence/machine learning mechanisms, there are potential risks to both user and patient. Cybersecurity is the gateway for evaluating vulnerabilities and protecting devices and patients. In this article, we examine how the EU has introduced new regulations regarding software, cybersecurity, and the impact on the total product life cycle development and innovation of new technologies. Privacy rules in compliance with the EU General Data Protection Regulation may present innovators with challenges by limiting AI’s usage of patient data.

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President's Message
The In Vitro Diagnosgtics Regulation and the role of medicals writers
Eudamed's delay and its impact on discolsure of clinical investigations under the EU MDR
Recent and upcoming regulatory changes in the European Region: Opportunitiess for medical writers
New documents required by the medical device regulation
Risk management plans in the EU: Managing safety concerns
Scientific advice procedures in the EU – an overview ofthe regulatory background
EU software regulations: The new normal or innovation stagnation?
The new PubMed – underestimated regulatory obstacles
Ethical challenges in acknowledging professional writing support
Publication management software for medical writers
Regulatory Matters
News from the EMA
Medical Devices
Medical Communications and Writing for Patients
Getting Your Foot in the Door
Lingua Franca and Beyond
My First Medical Writing
In the Bookstores
Good Writing Practice

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