EU MDR: The Challenge of Compliance by May 2020

Medical device manufacturers are less mature in their labeling management compared to peers in other regulated industries, because until now regulatory measures around traceability and reporting have been less pronounced. But with EU Medical Device Regulations (MDR) due to go live in just a few months, how will device manufacturers cope with the numerous implications for patient-facing content? Kallik’s Graham Francis measures the gap companies must close.

Graham Francis

November 15, 2019

5 Min Read
EU MDR: The Challenge of Compliance by May 2020

The EU’s new Medical Device Regulations (MDR) will go live in May 2020, to increase patient safety by making products more readily traceable. Among the requirements are significant implications for product labeling in all its forms. For instance:

  • Product information published on the manufacturer’s web site must be kept up to date, including labeling content.

  • Unique Device Identification (UDI) data needs to be uploaded to the EUDAMED database for all devices by May 26, 2020, with the UDI required on materials that fall under FDA’s definition of labeling to follow.

  • IFUs can now be provided in a non-paper format for the first time - manufacturers must indicate by means of a new symbol on the label that the IFUs are published in electronic rather than in paper form.

  • Device labeling must be provided electronically via the manufacturer’s web site as well as in traditional printed form.

  • Details of the organization’s EC representatives’ symbol, name, and address must be provided on the label.

  • A new symbol must be included on the label identifying the product as a medical device.

  • Additional symbols must be added relating to device reprocessing and safety.

Despite the long run-up to preparations, many organizations have underestimated the work and the time involved and are now worried about being compliant in time for the May deadline. This is unfortunate, not least because the new rules promote greater use of electronic labeling (e-labeling) and instructions for use (IFU) – something that should be much easier and more cost-efficient for manufacturers to work with, with the right controls in place.

So what’s the problem?

Historically, product & package labeling, IFUs, and web site content have been managed by separate teams across medical device organizations. In addition to the potential for discrepancies between all of this content, with scope for serious impact on patient health and outcomes, managing content across multiple disconnected systems and processes can delay the launch of products and entry into new markets.

But now there is the strongest reason yet to bring all of this under control: MDR, including its emphasis on electronic labeling output.

Scoping the challenge

Achieving MDR compliance requires that device manufacturers achieve coordinated control of all labeling outputs; optimize the use of ‘label real estate’, and achieve consistency across graphical and textual content wherever this appears; as well as positively embracing electronic labeling - to reduce wastage and per-country printing costs.

All of this requires, in turn, that:

  • Artwork teams creating labels collaborate more closely with the teams responsible for IFUs and booklets, in whatever format these appear. This includes those charged with looking after web content (for instance, external web management agencies).

  • There is a single place to go to get an accurate view of labeling content, wherever it appears - identifying where labeling artworks are stored, what the latest version is, and so on. This should encompass product-specific variants, country-specific requirements and localized content to keep track of.

Despite the time pressure, simply implementing a new factory print solution will not suffice as a strategy for achieving MDR compliance. This approach won’t cater to the changes needed to IFUs, booklets and web content, and it will not provide the single view necessary to ensure that labeling content published electronically aligns with factory and printed materials. Rather, medical device manufacturers need a means of achieving full transparency across all label assets - from individual symbols and statements, to label layouts and templates, IFUs, booklets, and other promotional materials – in whatever format these exist.

The process of locating the latest approved versions of each of these files and then importing these into the new solution should not be underestimated. Typically organizations find that there are double the amount of labels impacted by MDR than first thought, so it takes two or three times longer than anticipated to discover and collate the materials, so it is vital that companies lose no more time in implementing end-to-end control of enterprise labeling.

With full visibility of all assets, the task of updating labels, IFUs and booklets to ensure alignment with the new regulations can begin.

In parallel, a new data governance framework will be needed, ensuring that ownership of all labeling content is clearly defined and brought under control. Eventually, the ownership of all materials (including electronic versions) will come under the jurisdiction of the labeling team.

Once everything that is published can be managed and controlled within a single platform, it will be much easier to correlate changes across labels, IFUs, and booklets to ensure accuracy, alignment, and consistency. Where the managing software can export these files as XML content, this will ensure content can be sent directly to the web site for error-free publishing.

Final considerations

Given that medical device IFUs can be anything from 20 to 150 pages long, the need to have automated comparison tools for documents is becoming increasingly important, too. So this is a further consideration as companies look for improved reliability and new efficiencies.

Ultimately, a more structured approach to managing content collation, correct phrasing, addresses, and symbols, for re-use across multiple resources, will improve healthcare provider relationships and deliver better patient outcomes. It allows for the transition from documents to data, making it much easier to deconstruct and reconstruct labels, IFUs, and booklets built on shared and approved content.

All of which adds up to a more connected organization that is much better placed to embrace ongoing market and regulation-driven labeling changes.

About the Author(s)

Graham Francis

Graham Francis is Channel Marketing Manager at global enterprise labeling solutions leader Kallik, bringing to the role over 40 years’ experience of working with sophisticated software products to solve complex business problems in heavily-regulated industries.

[email protected]

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