Comar Leads the Way in EU MDR Compliance and CE UDI Labeling Innovations
Comar Sets New Standards in Healthcare Packaging
Comar, a pioneering force in healthcare packaging, has successfully achieved CE certification under the rigorous EU Medical Device Regulation (EU MDR 2017/745). This achievement underscores Comar's dedication to regulatory excellence and patient safety while signaling a significant move toward enhancing their leadership in the medical device packaging sector. With a robust investment in advanced Unique Device Identification (UDI) labeling capabilities, Comar is well-positioned to lead in compliance and customer support within European markets.
Understanding the Shift to EU MDR
The updated EU MDR introduces stringent requirements for traceability, mandating visible, legible, and indelible CE markings along with comprehensive UDI labeling on medical devices and their packaging. In responding to these requirements, Comar has developed and implemented sophisticated in-house systems to guarantee that each product adheres to UDI compliance. This includes compliance for both Device Identifier (UDI-DI) and Production Identifier (UDI-PI), presented in formats readable by both humans and automated systems.
Sonia Hardikar, the Vice President of Quality and Regulatory Affairs at Comar, emphasized the importance of the UDI labeling process, stating, "Our UDI labeling ensures clear identification, traceability, and facilitates swift recalls if necessary. Our focus is on safeguarding patients and easing compliance procedures for our clients."
Comar’s Capabilities and Client Support
As a notable contract manufacturer in the medical device industry, Comar is equipped to assign, generate, and apply CE labels and UDI codes across its extensive portfolio of medical devices. This range includes oral syringes, AccuCup® dosage cups, dropper assemblies, and press-in bottle adapters. Comar's adeptness doesn't end with its own products; the company also extends regulatory and labeling support for clients striving to navigate the complex EU MDR requirements when attempting to enter the European Union market.
Cari Smith, the Director of Quality Systems and Regulatory Affairs, stated, "We actively assist our clients in navigating EU MDR regulations. Our regulatory and labeling teams offer valuable solutions to ensure their products are ready for import."
Ensuring Continuous Market Access
Comar's proactive approach to obtaining early CE certification under the EU MDR guarantees a seamless transition for its clients into the European markets. This not only enhances the company’s status as a reliable partner amidst evolving regulatory conditions but also instills confidence in customers who seek dependable solutions in healthcare packaging.
Hardikar remarked, "Our investments not only bolster our readiness for EU MDR but also enhance our value to customers as they prepare for compliance. We aim to be the preferred partner in this evolving landscape."
About Comar
Headquartered in Voorhees, New Jersey, Comar operates across eleven strategic manufacturing locations. The company utilizes a variety of advanced plastic molding technologies, including injection molding and extrusion blow molding, thereby offering a full suite of value-added services. With over 75 years of experience, Comar has established itself as a trusted partner for clients seeking to launch impactful packaging and medical solutions from concept to fulfillment, thereby positively influencing the global healthcare landscape. Additionally, Comar has earned a Silver Medal in sustainability from EcoVadis, highlighting its commitment to environmental, social, and ethical responsibility. The company is predominantly owned by Morgan Stanley Capital Partners.
Conclusion
Comar's relentless pursuit of regulatory excellence and its innovative UDI labeling capabilities not only solidify its leadership in the healthcare packaging domain but also reaffirms its commitment to patient safety and compliance. As the company continues to support its clients in navigating the complexities of EU MDR, it positions itself as a vital ally in the medical device sector on a path toward continued success.