Comar Sets the Standard with CE UDI Labeling Capability and EU MDR Compliance

Company expands regulatory leadership and supports customer success in European markets

Comar has achieved CE certification under the EU Medical Device Regulation (EU MDR 2017/745), reaffirming its commitment to regulatory excellence, patient safety, and market leadership. In alignment with this achievement, Comar has invested in advanced Unique Device Identification (UDI) labeling capabilities, positioning itself at the forefront of compliance and customer support.

The updated EU MDR imposes stringent requirements for traceability, including visible, legible, and indelible CE markings and UDI labeling on devices and packaging. Comar has developed robust in-house systems to ensure each product is UDI-compliant, in both Device Identifier (UDI-DI) and Production Identifier (UDI-PI) in human- and machine-readable formats.

“Our UDI labeling process ensures clear identification, traceability, and swift recall if needed,” said Sonia Hardikar, VP of Quality and Regulatory Affairs at Comar. “It’s about protecting patients and simplifying compliance for our clients.”

As a contract manufacturer, Comar is equipped to assign, generate, and apply CE labels and UDI codes across its medical device portfolio, including oral syringes, AccuCup® dosage cups, dropper assemblies, and press-in bottle adapters.

Beyond its own products, Comar provides regulatory and labeling support for clients shipping devices into the European Union. “We actively help our clients navigate EU MDR requirements,” added Cari Smith, Director of Quality Systems and Regulatory Affairs. “Our regulatory and labeling teams offer practical solutions to help ensure readiness for import.”

Comar’s early CE certification under EU MDR ensures uninterrupted access to European markets and provides confidence to customers seeking a reliable partner in the evolving regulatory landscape.

“Our investment enhances our value to customers preparing for EU MDR,” added Hardikar.