Following the implementation of the Unique Device Identifier (UDI) regulation in America, other countries and regions are now fasttracking the adoption of medical device regulations in their respective jurisdictions. Next one up with significant implications is the European Union which has set a compliance date of May 2020. The EU’s Medical Device Regulation (MDR) went into effect in May of 2017 to establish greater control and transparency on the quality and safety of medical devices manufactured or imported to the EU. A key  component of the MDR regulation is the European Database on Medical Devices (EUDAMED) that collects certain medical device data from manufacturers and makes them accessible to the public. Unlike the FDA’s Global Unique Device Identification Database (GUDID), EUDAMED requires more extensive data including unstructured information related to clinical investigations, safety & performance studies, vigilance and market surveillance.

As such, the UDI data required by the FDA is just one of six modules covered in EUDAMED, which are:

• Actor Registration
• Device Registration (UDI)
• Notified Bodies & Certificates
• Clinical Investigations & Performance Studies
• Vigilance
• Market Surveillance

As stakeholders await the final technical specifications from the European Commission on UDAMED, manufacturers are scrambling to understand the requirements, collect the relevant data and establish a process to submit data to EUDAMED under pressing time constraints. Innovit’s MDR Connector solves these challenges by allowing device manufacturers to implement a “global system and unified process” that is fully integrated with internal systems for submitting both structured and unstructured data to EUDAMED.