News - Page 7 of 8

Requirements for mHealth apps in terms of advertising law

Category: product liability Industry: healthcare Author: Miriam Schuh Date: 2018

The classification of mHealth apps as medical devices is geared primarily to their intended use as declared by the manufacturer. An article by Miriam more...

Who is liable for digital products?

Category: cybersecurity , future law Industry: mobility, consumer goods, healthcare Author: Philipp Reusch Date: 2018

EU Cybersecurity Act vs. cyber-resilience. An article by Philipp Reusch at computerwoche.de more...

History and liability of Qualified Persons

Category: compliance , product liability Industry: healthcare, cosmetics Author: Miriam Schuh Date: 2018

pharma technologie journal. A publication by Miriam Schuh in 'The Qualified Person', 2nd issue 2018

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Software as a medical device

Category: product liability , product safety , future law Industry: healthcare Author: Miriam Schuh Date: 2018

For software to qualify as a medical device, the question of whether or not it has direct action in or on the human body is not relevant. The sole more...

Insurance against the costs of recall campaigns – what do manufacturers need to pay heed to?

Category: recall management , product liability , insurance law Industry: consumer goods, cosmetics, healthcare Author: Philipp Reusch Date: 2018

The judgement on care patients' beds and insurance against the costs of recall campaigns. The third and last article in our series on risk management more...

Labelling obligations relating to consumer products

Category: product safety , compliance Industry: consumer goods, cosmetics, healthcare Author: Philipp Reusch Date: 2018

Product safety. A breach of labelling obligations as they relate to product safety law can have far-reaching consequences more...

Tighter requirements for manufacturers and increased liability risks

Category: compliance , product liability Industry: healthcare Author: Miriam Schuh Date: 2018

Medical Device Regulation – classification, quality management, UDI labelling and liability. An article by Miriam Schuh in the specialist journal more...

Cyber-security is an MDR topic too

Category: cybersecurity , compliance Industry: healthcare Author: Daniel Wuhrmann Date: 2017

In order to give hackers no chance when it comes to medical devices, manufacturers must consider the state of the art in IT technology at all times more...

Status quo of ‘delegated & implementing acts’

Category: compliance Industry: healthcare, cosmetics Author: Miriam Schuh Date: 2017

Medical Device Regulation: Status quo of ‘delegated & implementing acts’. Since the new EU Regulation on medical devices (MDR) came into force on 25 more...