Following up on a joint statement signed on July 25, 2018, by Presidents Juncker (European Commission) and Trump (US), an interim report was published on January 30, 2018, providing an overview on the work done by the US-EU Executive Working Group (EWG).

US and EU commit to bridge the medical device regulatory gap concerning UDI

With the facilitation of transatlantic trade in mind, the EU and US pledge to cooperate, in synergy with ongoing International Medical Device Regulators Forum (IMDRF) endeavors, to improve the identification and tracking of Medical Devices placed on the market. Their concerted efforts are aimed at ensuring the alignment of the electronic database specifications for Unique Device Identifiers (UDIs) and developing a plan for bilateral test of compatibility of respective UDI.

Furthermore, the US and EU currently enforce different medical device regulatory systems that often involve duplicate testing of products, therefore causing delayed access to Medical Devices, as well as higher costs for patients.

To this end, EU pledges to employ active efforts towards making use of single audit reports (an initiative developed by the IMDRF) “in a manner that is compatible with EU legislative requirements”. Although not without its challenges, this initiative is surely welcomed and within reach.

The US is a member of MDSAP, operational since 2017, allowing auditing organizations to conduct a single audit of a medical device manufacturer, simultaneously satisfying multiple regulatory jurisdictions regarding Quality Management Systems (QMS) and Good Manufacturing Practices (GMP) requirements. Existing regulatory differences, however, limit the use of MDSAP on a broader scale, including the EU.