Transform your labeling to comply with EU MDR

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.

What is EU MDR?

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:

Keep pace with EU MDR regulations

Loftware helps medical device companies of all sizes manage labeling in a regulated environment by simplifying validation and compliance.

Altsysteme überdenken

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.

Ihre Daten zentralisieren

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.

Zuverlässige Datenquellen integrieren

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.

Etikettenänderungen beschleunigen

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.

Auditierbarkeit sicherstellen

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.

Datengesteuerte Etikettierung ermöglichen

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.

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