EU Medical Device Regulation: What Does It Mean For The Sticky Label?

The EU MDR introduces additional information that needs to be included on labels, forcing organizations to design new label templates that make room for more data. It’s both a design and a data challenge that must quickly be addressed to avoid a sticky situation, writes Mark Cusworth in this guest column.

Printing at high speed on offset machine. Label, Rolled Up, Printing Out, Group of Objects, Merchandise
About The Author

Mark Cusworth is VP of research and development at Prisym ID, which designs and delivers label management software for organizations that need complete product auto-identification and life-cycle traceability. To find out more about the MDR’s impact on labeling, check out this PRISYM ID webinar.

The definition of "label" has, in the past decade, expanded to include items such as multi-language booklets and instructions for use (IFUs). The EU Medical Device Regulation introduces new rules around these crucial materials.

But what does the EU MDR mean for the sticky label itself?

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Regulation

NHS Orders Halt On Unapproved AI Scribes, Vendors Rush To Self-Certify

 

NHS England's national chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.

Time For Medtech To Have Its Say On Critical Changes In EU Framework Legislation

 

In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.

HHS Suggests Drastic Reductions To Skin Substitute Payments

 
• By 

The US Department of Health and Human Services has proposed cutting Medicare reimbursement for skin substitutes used in chronic wound care by up to 90%. The change aims to address rising costs but could harm patient access and treatment quality, prompting concerns from industry stakeholders.

International Reliance Gets UK MHRA OK In Drive For Agile Pre-Market Regulation – CE Marking Next

 
• By 

The UK government’s response to MHRA public consultation on risk proportionate device routes to market and physical UKCA markings adds momentum to drive for modern, agile system. Another consultation in late 2025 will propose indefinite recognition of CE-marked devices in Great Britain.

More from Policy & Regulation