Editor’s Note: Originally planned for 2020, EU Medical Device Regulation (EU MDR) implementation has been extended to 2021. The regulation mandates identification and traceability measures for all medical device labeling in the EU. The regulation highlights flaws within manual labeling processes and, for some manufacturers, could require a complete overhaul of global labeling management operations. Bob Tilling, vice president of Global Sales at Kallik, explains that streamlining labeling processes now will ensure businesses are compliant with regulations and are prepared for future regulatory changes. Because this time around, products really do have to do what they say on the packaging.

For some medical device manufacturers, the EU MDR’s delay to 2021 may come as good news, but manufacturers should not use the extension as an excuse to ignore making operational changes until just before the deadlines. Rather, they should take the opportunity to properly prepare operations for increased compliance.

Bob Tilling

Physical labels are typically templated and printed manually on the factory floor using data from enterprise resource planning (ERP) systems. Other customer-facing materials such as instructions for use (IFU) leaflets tend to come from separate teams or external design agencies. This disjointed approach will not be sufficient as the EU regulations assume more systematic process coordination and content uniformity.

For many, the upcoming regulation will require a labeling change and a complete overhaul of the labeling process to ensure consistency.

Manufacturers face four key challenges to be EU MDR compliant, and capable automated labeling solutions will be central to this process.

1. Identification, traceability

Incorrect labeling means products don’t have the required transparency as they move from factories, through distribution, to the hospitals, surgical centers, and pharmacies. Incidents such as the PIP breast implant scandal of 2009/2010 could still wreak havoc. This is what MDR is designed to avoid.

Under MDR, everything from bandages and crutches to digital patient monitoring devices, contraceptive implants, hearing aids, and pacemakers will need to carry a unique device identifier (UDI) on all labeling, enabling rapid lookup if an issue occurs. Faulty batches of products can be pinpointed for targeted remedial action – but this depends on accurate, consistent, and reliable labeling.

The stringent MDR measures also demand logging information in a huge central EU database, EUDAMED – a prerequisite for marketing medical devices in European markets. Products must be correctly labeled with specified safety information and symbols and meet requirements around electronic IFUs. Devising a more defined strategy for enterprise labeling and artwork is critical.

Any change to labeling can threaten the quality and reliability of what is issued, as even simple adjustments can compromise the layout, leave a barcode partially missing, or obscure critical wording. So, manufacturers must not rely on ad-hoc manual processes to ensure all ensuing output meets the new regulations consistently and definitively.

2. Single source of truth

Manufacturers can’t maintain product identification and traceability, or manage this with rigor and efficiency, if they don’t have clear visibility, control, and systematic coordination across everything included on or with their products – through every channel, in every market.

In the final countdown to MDR compliance, many manufacturers will realize that their internal systems cannot handle the requirements across global operations. Teams may know what they must do, but getting the right labels onto products and packaging when manufacturing and distribution operations span locations in the Far East and U.S., as well as Europe, is a big challenge.

The only way to ensure consistency and reliability is to digitize the labeling process and have a single source of labeling truth from which all market-facing product information and materials flow – one definitive place to update and check everything which any authorized team can access anywhere in the world, supported by appropriate controls governing who can do what with the content assets.


3. Label management consolidation

The biggest impact MDR will arguably have on medical device manufacturers relates to the scale of work involved – but many companies will underestimate this and delay projects. Dispersed teams and disjointed processes, as well as inevitable duplication between content sources such as translation databases (where these have existed separately for label and IFU creation), make for highly complex scenarios that take time to unravel. This all needs to be done before improvements can be implemented to streamline and automate processes, such as change management.

If organizations leave MDR preparations until the eleventh hour they’ll be forced by time pressures to do the minimum required for compliance, even if that’s a costly workaround that doesn’t deliver the quality control, compliance, confidence, or process efficiencies the manufacturer needs.

4. More regulatory changes ahead

Regulatory disruptions are not a one-off event. MDR won’t be the only major global change in the industry, so companies that don’t take the time to properly implement change are likely to have to do it all again. For example, product serialization on device labeling is likely to become mandatory in the coming years.

For the time being, manufacturers marketing products in Europe only need to provide UDI information to the EUDAMED database, but starting in May 2021, unique product identifier codes and detailed product serialization information will have to appear on all product labeling. The 2021 deadline applies for Class III devices – the most safety sensitive – followed by Class II in 2023, then Class I items in May 2025. The UDI must appear in plain text on all parts of a product’s packaging, be machine-readable, and include a wealth of very specific information under two different categories – a Device Identifier (DI) and a Production Identifier (PI). There’s a lot to get right in the coming months and years.

5. Seize the moment

This is the first time in the medical device sector that label and IFU changes have come simultaneously, showing manufacturers how inadequate some of their existing disconnected processes are. If they haven’t already, companies need to review the extent of their inefficiencies and start working toward a common approach to managing market-facing information based on common content, shared data, and more connected ways of working.

By implementing a consistent and compliant labeling solution, medical device manufacturers don’t only optimize their global label management processes, they increase accountability and transparency, and reduce compliance risks ahead of the MDR deadline and any future regulation changes. Remember, manufacturers who appear ready to comply, even going the extra mile to give consumers the reassurances they need, will gain market confidence around their brand. The desire for greater transparency and consumer self-service is not going to go away, so the more manufacturers can do proactively to satisfy this need, the better received their products will be.


About the author: Bob Tilling is VP Global Sales at Kallik. He can be reached at sales@kallik.com or +44 1827 318100.