News - Page 7 of 7

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...

Medical devices in the Eurasian Economic Union (EAEU)

Category: product safety , compliance Industry: healthcare Date: 2017

Common market for medical devices and medicines in the EAEU now in force more...

Update Internet of Things (IoT)

Category: compliance , product safety , product liability Industry: healthcare, consumer goods, machine construction Date: 2017

Important act of law for IoT, Industry 4.0, digitalisation and connectivity. Since as long ago as 13 June 2016, the regulatory requirements for radio more...

MDR and IVDR published in Official Journal of European Community (OJEC)

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

On 5 May 2017, the MDR and the IVDR were published in the OJEC. So the final countdown is now on until the two regulations come into force and a new more...