UDI Expert Talk: EU MDR UDI requirements – Strategies for addressing US and EU direct marking compliance

In addition to labeling and packaging requirements, the US Food and Drug Administration’s (FDA’s) Unique Device Identification (UDI) regulation and the European Union’s (EU's) new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) require certain devices to have UDI direct marking.

With the US Class I and EU MDR Class III direct marking compliance deadlines approaching, join us to learn about the differences in the requirements and strategies for compliance. USDM Life Sciences will address the requirements for US and EU MDR direct marking, FOBA will address how best to implement direct marking, and USDM will also provide QMS and validation guidance for direct marking.

This discussion will include:

- US Class I and EU MDR Class III direct marking compliance requirements
- Nuances and differences in the US and EU requirements
- Strategies to address the differences and simplify your UDI and validation efforts
- Implications to your Quality Management System (QMS)