Medical Devices: Find your path through the regulatory jungle

Published Date
Jan 2, 2024
In Germany and the EU, medical devices are subject to a complex and evolving regulatory framework, covering aspects such as safety, performance, clinical evaluation, labelling, post-marketing surveillance and environmental considerations.

Eda Zhuleku, Stefanie Günther and Florian Preinfalk have summarised the German legal framework for medical devices, which is to a large extent based on EU law, in a practical note published on Thomson Reuters Practical Law. The practice note provides an overview over the regulatory regimes applicable to various types of medical devices, such as software, drug-device-combinations, electric medical devices and medical devices using chemicals. It covers aspects throughout the lifecycle of a medical device, from the development phase to its end of life.

You can read the article here.

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This content was originally published by Allen & Overy before the A&O Shearman merger