Solutions  >  Regulatory  >  EU MDR

EU MDR milestone - Is Your Labeling and Artwork Ready?

With the next major milestone for EU MDR (Medical Device Regulation) quickly approaching, medical device companies need to reassess their label and packaging artwork processes to ensure compliance. Whether a large global company with international reach or a smaller manufacturer in medical device market, these pending changes will have major implications for your business.

Download EU MDR Report

Six Keys to Compliance

To ensure compliance you need the correct identifiers in the correct place. That means you need a validated labeling and packaging artwork solution, with access to centralized data, audit tracking and security controls, workflow management and eSignature capabilities, which can quickly expand use for evolving regional and international regulations.

Re-think Legacy Systems

Spreadsheets, legacy systems and even some labeling software packages are not secure. You need an automated, validated solution that can easily accommodate new requirements and safeguard against future regulations.

Centralize Your Data

Your business may have many locations, but that doesn’t mean it should be “every entity for itself.” Centralized labeling brings visibility and control – and the ability to demonstrate compliance.

Integrate Sources of Truth

Best practice for managing EU MDR and other labeling regulations is to source data from approved content management systems, trusted ERPs and other applications that generate serial numbers required for EU MDR.

Enable Label Changes

Business users should be able to create and manage labels and configure business rules without calling on scarce IT resources. This allows them to quickly respond to any changing regulations.

Ensure Security/Auditability

You need a solution that provides full auditing and reporting capabilities, with business intelligence to monitor and track all labeling activity - as well as eSignature capabilities - to ensure you safely meet regulations.

Enable Data-Driven Labeling

It’s important to have dynamic, data-driven labeling which enables users to manage a single template for a range of labeling variations to support increasing complex requirements and ultimately speed up the validation process.



Important EU MDR Dates

Adoption of the new infrastructure and EU Portal, along with reporting procedures and transitional arrangements are scheduled to take effect next year with other transitional deadlines to follow. Here are the pending deadlines for compliance:

mar2020-2

 

Estimated Go Live for EU Database for Medical Devices (EUDAMED)

may2020-2

 

Date of application of EU MDR

may2022

 

Date of application of IVDR (In Vitro Diagnostic Medical Device Regulation)

may2024

 

Notified Body certificates issued under MDD designation become void

may2025

 

End of the transition coming for the few final devices



Resources

EU-MDR-LP

EU MDR report

With the next major milestone for EU MDR (Medical Device Regulation) quickly approaching, medical device companies need to reassess their label and packaging artwork processes to ensure compliance. Whether a large global company with international reach or a smaller manufacturer in medical device market, these pending changes will have major implications for your business.

Learn More →
spectrum4

Spectrum for Medical Device

Loftware Spectrum® for Medical Device redefines how enterprises create, manage and print labels, enabling medical device manufacturers of all sizes to meet rigorous regulatory requirements as they seamlessly implement, deploy, maintain and scale their labeling operations globally.

Learn More →

Loftware EU MDR Solutions

Ultimately, when it comes to managing medical device labeling, you’ll want a solution that enables compliance with EU MDR, FDA UDI and 21 CFR Part 11 regulations and supports validated environments. With Loftware, you’re able to keep pace with EU MDR, and quickly expand use for any evolving regional and international regulations.  

Request Consultation