Whether you’re a global medical device organization with international reach or a smaller specialist manufacturer, Loftware’s labeling software can transform your label and packaging processes. We enable compliance with the latest industry regulations and support scaling product identification across your enterprise.
The European Union Medical Device Regulation (EU MDR) is a comprehensive regulatory framework (Regulation (EU) 2017/745) that governs the safety, performance, and labeling of medical devices. If you supply products to the EU, manufacturers must comply with this regulation to legally place them in the EU market.
EU MDR makes labeling more detailed, regulated, and traceable, aiming to enhance patient safety and product transparency. Manufacturers must update their labels and Instructions For Use (IFUs) to ensure full compliance and give public access via EU Medical Device Database (EUDAMED). Failing to do so can prevent a product from being legally marketed in the EU.
Labeling is an area critically impacted by EU MDR including:
Device identification
Language requirements
Symbol usage
Devices must include a Unique Device Identification (UDI) on their label and packaging to facilitate traceability and easier recalls
Loftware helps medical device companies of all sizes manage labeling in a regulated environment by simplifying validation and compliance.
Implement an automated, validated-ready solution that can easily accommodate new requirements and safeguard against future regulations rather than rely on spreadsheets, legacy systems, and basic labeling software packages that are not secure.
Your business may have many locations, but that doesn’t mean it should be “every entity for itself.” Centralized cloud labeling brings visibility, scalability, and control – providing the ability to demonstrate compliance globally.
Best practice for managing EU MDR and other labeling regulations is to source data from approved Content Management Systems (CMS), trusted Enterprise Resource Planning (ERPs), and other applications that generate serial numbers required for EU MDR.
Business users should be able to create and manage labels and configure business rules without calling on stretched IT resources. This allows users to quickly respond to any changing regulations.
Provide full auditing and reporting capabilities, with business intelligence to monitor and track all medical device labeling activity including eSignature capabilities to ensure all regulations are met correctly.
Enable users to manage a single template for a range of labeling variations to support increasingly complex requirements with dynamic, data-driven labeling, speeding up the validation process.
We needed to have a controlled release process that started from our head office in Belgium. So, our goal was to implement an integrated label management process that guaranteed accurate labels and data integrity.
Patrick Taels
ICT Manager
ラベルの作成方法について監査員と30分かかっていた会話を、システムにログインして実際のラベル画像を監査員に提出する数分に短縮することができました。
Michael R. Kinnett
医療製品部門、製品のラベル管理
当社は現在、医療機器のグローバル市場へのアクセスを確実にし、必要に応じてラベルの内容をカスタマイズすることができるようになったため、製品承認の迅速化と規制遅延の削減につながっています。
Mark Illgner
ラベル開発シニアエンジニア
The Product Labeling team can support over 3,800 SKUs with only 75 label designs and 7000 image files. The team can easily swap format files and images based on customer needs, quickly adjusting languages, product brand name, size details, information, and instructions on the labels to comply with regional customer or regulatory requirements.
Michael R. Kinnett
医療製品部門、製品のラベル管理
