Tighter requirements for manufacturers and increased liability risks

Category: compliance, product liability Industry: healthcare Author: Year:

Medical Device Regulation – classification, quality management, UDI labelling and liability

An article by Miriam Schuh in the specialist journal Haftpflicht international – Recht und Versicherung (PHi), (“International public liability – law and insurance”) issue 2017, no. 5

Since May of this year, the new European regulations for medical devices and in vitro diagnostic medical devices have been in force. The aim of the new regulations is to create a higher degree of safety for patients and users. Accordingly, the obligations of manufacturers in particular have been extended and tightened. 

Miriam Schuh explains what really matters when it comes to classification, quality management, UDI and liability for manufacturers, and why there may be bottlenecks, particularly for small and medium-sized businesses.