Comar Achieves CE Certification for Medical Devices Under New EU MDR Regulations
BUENA, N.J., May 29, 2024 /PRNewswire/ -- COMAR, a leading provider of innovative medical devices and packaging solutions, is thrilled to announce a significant achievement. After rigorous preparation, they successfully obtained their CE certificate under the latest EU Medical Device Regulations (EU MDR 2017/745).
This certification is a significant milestone, marking COMAR's compliance with the latest European Union medical device standards. The new EU MDR introduces more stringent requirements for the safety and performance of medical devices, seeking to ensure patient safety and device traceability. The successful certification demonstrates COMAR's commitment to excellence and to bringing high-impact solutions to market, where they can positively impact the world around us.
With this certification, COMAR can continue to sell CE-marked Oral/Topical Dispensing Devices in the European Union, specifically Class I devices with a measurement function and Class I non-measuring devices, which are press-in bottle adapters. The certification covers COMAR's Oral Syringes, Dosage Cups (AccuCup®), Dosage Spoons, Dosage Scoops, and Dropper Assemblies.
"Receiving the new CE certificate under the EU MDR is a testament to the dedication and hard work of our entire team," said Sonia Hardikar, VP of Quality and Regulatory Affairs at COMAR. "This accomplishment reflects our unwavering commitment to delivering safe and reliable medical devices to our customers. We are excited to continue serving our European clients while exploring new opportunities with this certification."
COMAR extends its heartfelt gratitude to everyone involved in this significant milestone. We sincerely appreciate the dedication and hard work of our entire team, the support of our valued customers, and the collaboration with the certification body and auditors. This achievement sets the stage for continued growth and innovation in the medical and pharmaceutical device sectors.
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Comar, headquartered in Voorhees, NJ, has 11 strategic manufacturing and distribution locations and employs a host of plastic molding technologies, including injection molding, injection blow molding, injection stretch blow molding, and extrusion blow molding, which are complemented by a full suite of value-added service offerings. For 75 years, Comar has partnered with clients to launch high-impact packaging and medical solutions—transforming them from concept to reality, where they can positively impact the world around us. Comar is majority-owned by Morgan Stanley Capital Partners.
SOURCE Comar
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