Bringing a Medical Device to The European Union
To comply with EU Regulations, there are a number of complex regulatory-related tasks that will need attention. Medical device registration and Unique Device Identification (UDI) are two major areas with specific requirements. Voluntary industry activity has been underway for some time in preparation for the anticipated launch of the EUDAMED database. The Actor Module and the UDI/Device Registration Module are open to voluntary submissions. Starting a regulatory strategy early in the process will help in getting to market for both the US and EU.
What is EUDAMED?
EUDAMED (European Database on Medical Devices) is the web-based portal implemented by the European Commission to serve as a centralized database for economic operators (medical device manufacturers worldwide, designated representatives and system/procedure pack providers) for the registration and required EU regulatory information submission. The existing three directives for the European Union–Medical Devices (MDD), Active Implantable (AIMDD) and In Vitro Diagnostics (IVDD)–have been replaced by two regulations: the Medical Devices Regulation (MDR) 2017/745 and the In Vitro Diagnostics Regulation (IVDR) 2017/746. Unique Device Identification (UDI) database requirements are being implemented by a number of global health regulators to improve the safety of patients and facilitate product modernization.
How do the US FDA and EU Medical Device Regulations Compare?
The EU MDR regulations are more similar to US FDA in many areas, especially around quality system compliance and conformance with international standards. Key differences still exist in understanding stated ‘conditions’ and scenarios. We took a side-by-side approach to understanding the similarities and differences. Fill out the form to see a side-by-side list of comparisons as well as other resources pertaining to FDA and EU regulations.
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Unique Device Identification (UDI)
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