Get your labels ready for EU MDR
The date of application for the European Union Medical Device Regulation (EU MDR) is May 26, 2021.
What do you need to know in order to be ready for the deadline?
And how can you ensure that your labeling system and processes are MDR-compliant?
This guide highlights five key steps to getting your labels ready for EU MDR.
Labeling: mission-critical for medical device manufacturers
The medical device industry is on track to see a 35% increase in recalls in 2020.
Source: Stericycle Expert Solutions
In 2018, mislabeling was the 2nd most common cause of medical device recalls.
A single major recall can cost medical device companies as much as $600 million.
Source: McKinsey & Company
On average, the FDA issues 1.5 medical device recalls each week.
Create a standardized labeling environment
Many medical device manufacturers struggle with a siloed approach to label production, with separate systems for each stage of the labeling process. Our labeling solution unites every labeling task on one platform, from design to management to print. It also integrates with your business systems and printers becoming the central point of contact for all of your systems.
Simplify the label design change process
- Design complex labels that can be used across any printer brand or model in minutes, without coding.
- Use universal templates and the graphical “label comparison” tool to consolidate label designs and reduce the number of label variations.
- Improve speed and flexibility in making label changes.
Digitize quality approval workflows
- Digitize and standardize label approval processes to avoid manual quality assurance and mislabeling.
- Automate mass label changes and approvals without creating hundreds of label variations.
- Keep full control of all label changes and get full traceability and visualization of every label ever printed.
Comply with regulatory requirements
- Use a labeling system designed to comply with FDA UDI and EU MDR regulations.
- Maintain a compliant labeling process using built-in role-based access, document versioning, configurable approval workflows, electronic records and electronic signatures (ERES)
- Easily validate your system with our validation acceleration pack and services.
Integrate labeling with your DI and PI data
- Integrate labeling with ERP, PLM, MES or proprietary systems for a ‘single source of truth’ for your label data.
- Secure UDI information on labels to prevent errors and unapproved label changes.
- If you have a Cloud-first IT strategy, use NiceLabel Cloud for Cloud-to-Cloud integration to connect labeling with your other business systems.
Extend standardized labeling to your business partners
- Extend standardized labeling to contract manufacturers, distributors and other suppliers within minutes.
- Improve supply chain efficiency, while reducing labor and inventory costs.
- Guarantee accurate labels regardless of suppliers’ printers and IT infrastructure.
The world’s first validation-ready,
multi-tenant cloud labeling solution
NiceLabel Cloud Compliance helps companies of all sizes manage labeling in a regulated environment by simplifying validation and compliance.
Getting your labels ready for EU MDR: Five steps to ensure your systems and processes are optimized for compliance
The date of application for the European Union Medical Device Regulation (EU MDR) is May 26, 2021. What do you need to know in order to be ready for the deadline? And how can you ensure that your labeling system and processes are MDR-ready? We’ve prepared this brief guide to help you on the path to EU MDR-compliant labeling.
We partner and integrate with
Digitally transforming labeling leads to tangible results
71% of the medical device companies on the Forbes 2000 list use our technology
Using our label management system, medical device manufacturers can respond more quickly to changing market conditions and requirements; ensure accurate, consistent labels and get products to market faster.
Medical device labeling success stories
How LiNA Medical drove process improvement to reduce man hours as part of its UDI compliance initiative.Learn more >
Medical device company achieves global compliance while improving labeling accuracy and reducing costs.Learn more >
Global Healthcare Company streamlined labeling to improve operational efficiency.Learn more >
Global dental device manufacturing company discovers an Oracle integration alternative that reduces licensing and implementation costs while delivering compliant labeling.Learn more >
Let us help you transform your labeling
We know that labeling is a business-critical function in the medical device industry. Your labeling system needs to meet the unique regulatory requirements and market demands in every country where you do business. Our Professional Services Group (PSG) is a team of trained industry professionals who offer services tailored to life science companies. PSG works with you to ensure your system is configured and implemented according to best practices, and that it is validated according to medical device industry standards. They secure the smooth, efficient transformation of your labeling.