American Made. EU MDR Approved.
Secure your supply chain and MDR regulatory approval with Merit’s American made and MDR certified syringes.
Custom Plunger Colors
Merit Receives First MDR Certificate for CE Marked Syringes
The MDD to MDR transition period concluded with the official MDR date of application on May 26, 2021. During this transition period, Merit’s global team has worked on the comprehensive implementation of the European Union’s new Medical Device Regulation (MDR).
After months of diligent work, Merit received our first MDR Notified Body certificate of compliance for our complete line of PC and COP syringes. Merit’s global cross-functional team continues to work on MDR compliance for our complete product catalog, now that MDR is required for CE marked products.
Merit’s Certified MDR Compliant Syringes
Many of our OEM partners depend on Merit’s CE mark for accessory products, like syringes, as they launch their own products in the EU. This allows our OEM partners to reduce their regulatory costs and increase their speed to market.
The following syringe product lines have been certified MDR compliant in both sterile and non- sterile configurations.
Customizing Merit’s Proven Products
Partnering with Merit OEM means complete access to Merit’s Core Products. Customize one of Merit’s proven products to meet your specific requirements. Syringe customization options include:
Custom CE Marked Sterile Syringes
Working with Merit OEM provides you with Merit’s regulatory, legal, engineering, and manufacturing capabilities to bring a MDR certified sterile syringe to the EU market. Setting up your private labeled sterile syringe with Merit OEM includes:
Request a virtual meeting with Merit’s Product Development Team
Toll-Free: +1 800 637 4839
Phone: +1 801 208 4313
Hours: 8 am to 5 pm MST | Mon-Fri
