Are you ready for the EU Regulations on Medical Devices and in vitro diagnostics?

Find out more helpful information in this paper created by our specialists in the topic and get your EU Regulatory CE Mark for IVD and MD right.

Currently medical devices and in vitro diagnostics are subject to the trinity of long-standing directives—Medical Device Directive (MDD), In Vitro Diagnostic Medical Devices Directive (IVDD), and the Active Implantable Medical Device Directive (AIMD). However, one of the most recent European regulatory overhauls in the life science industry was the publication last year of the new EU medical device and in vitro diagnostic medical device regulations.

These regulations  affect the device manufacturers but also any party that is a part of the supply chain or providing service activities. The regulatory changes are driven by a need to strengthen the regulatory platform, standardize and harmonize information and create a safer environment for patients and users.

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