Here, Bob Tilling, VP Global Sales at Kallik, shares his experience from recent customer projects and explains how medical device manufacturers can recover lost time when preparing for EU MDR labelling and IFU compliance — and make sure they are better positioned for other regulations that are bound to follow.
Certain industry commentators have suggested that the one-year delay in new EU MDR rules has helped to buy medical device manufacturers enough time to “fix” issues with their enterprise labelling. But, despite the extended timeframe, the postponement has not changed the scale of the task at hand.
The new MDR regulations are four times longer and contain five more annexes than the EU Medical Devices Directive (MDD) and will require most medical device manufacturers to update their clinical data, technical documentation and labelling.
Many device manufacturers have miscalculated the scale of the task. Initial estimates of Class III device labels and IFUs have typically been out by a factor of three or more — 100 IFUs and 2000 labels have become 300 and 6000, respectively.
Ensuring compliance across labels, cartons and IFUs for every single device adds another dimension. Once extrapolated out across Class II and Class I devices, then both the second and third waves of EU MDR start to look alarming.
Even those organisations that have emerged from the maze of Class III device labelling realise they require a better map next time. Others who are yet to start their EU MDR change project face many blind alleys.
Bob Tilling
Once the labelling is done, IFUs are up next … as are Patient Implant Cards. Some manufacturers have started to recover lost ground on labels and are now getting to grips with the challenge of addressing IFUs. But, worryingly, others are still burying their heads in the sand.
The IFU problem defined
A mid-sized device manufacturer may have anything from 100 to more than 1000 IFUs across their product line. Rewriting these content-heavy documents in a style that’s appropriate for the user, adding new symbology and statements, plus translating the text into languages for 20+ EU countries makes the task of updating these to comply with EU MDR larger than first anticipated.
There’s also a disconnect to bridge between labels and IFUs — where little, if any, upstream alignment exists. Often, the first time labels and IFUs come together is at the point of packaging and shipping, not the ideal time or place to be checking for consistency.
IFUs also tend to be owned by artwork teams rather than labelling teams and don’t change as regularly, limiting capacity for wholesale changes. When IFU artworks are outsourced, there is the added risk that agencies lack the resources to manage the changes in required timescales — if they actually comprehend exactly what is required.
There are important IFU distinctions for those manufacturers that also sell products outside the EU. Content from translation agencies will also need to be included, followed by several internal review and approval cycles before going to print.
PLM will not bail out medical device manufacturers – and there are labelling lessons to be learned
Product lifecycle management (PLM) does not provide the silver bullet to EU MDR compliance. There may be multiple production variants of a single label stored in PLM software, derived from the need for localised content, different pack sizes and varying production data.
Geographically dispersed factories operating a variety of labelling software solutions make it impossible to gain a single view of these variants.
Additionally, IFUs arriving via a different route into Goods Inwards may bypass PLM systems entirely. Despite regulatory departments being responsible for what goes on the labels, they may not have sight of the finished goods, being left to rely on the efficacy of less qualified colleagues.
Some organisations are making headway in the transition from MDD to MDR from a labelling perspective. Some device manufacturers are approaching MDR as an opportunity for business transformation, whereas others have tried to force feed change into already broken processes.
Already reaching breaking point for Class III, these processes won’t scale for Class II and Class I devices. Many are quickly learning that it takes much longer than forecasted — taking 3 months to locate all the impacted labels, 6 months to complete the change cycle followed by 3 months of print and publishing lead-times — equivalent to one year of elapsed time plus another 3 months to achieve certification.
The timescale could be even longer for extensive IFU documents. The worst-case scenario is that some devices might not ship, disrupting global healthcare supply chains, revenues and shareholder confidence.
Cloud-based labelling and artwork management software brings medical device manufacturers into the future
This is where cloud-based artwork and labelling management software helps to quicken the EU MDR migration. In a fraction of the time taken by labelling teams to extract content from legacy systems, a cloud-based solution can be operational and ready to recoup lost time.
Bringing all labelling and IFU content together in a single solution that fully integrates with localised print facilities and third-party agencies enables globally dispersed teams to operate from a single source of truth.
By removing siloes of information and automated manual processes, they also guarantee safety and security with full traceability and accountability.
Advanced software tools and techniques reduce the number of label and IFU template variants, minimising the risk of errors and non-compliances from misinterpretation — and shortening creation and review cycles.
In the context of MDR, finding impacted labels, updating content, designing new label and IFU layouts, managing translations and demonstrating 21 CFR Part 11 compliance starts and finishes with cloud-based artwork and labelling management software.
Case in point: artwork management and labelling software delivers quantifiable benefits
Mid-sized Class III device manufacturers producing approximately 350 IFUs typically forecast more than 3500 hours to achieve readiness for EU MDR certification, based on current systems and processes.
Average statistics from medical device manufacturers using the Kallik Veraciti solution show that creating multiple language EU MDR-compliant 30-page IFUs can be reduced from 3–5 hours to just 30–40 minutes. Generating individual labels is reduced from one hour to around 10 minutes.
With 350 IFUs and 10,000 labels, 5 work years of lost time has been recovered for Class III devices alone, freeing up resources to start preparing for Class II compliance.
When external agencies are engaged, economies increase further. Translated text and phrases can be stored and reused. Streaming label and IFU layouts and content directly into InDesign also minimises the number of design studio iterations.
Applying business rules logic to prepopulated label templates for locale-specific variants reduces error-prone repetitive tasks and minimises dependence on tribal knowledge.
Avoid the side-effects of non-compliance: now and in the future
Beyond EU MDR, more labelling changes are on the horizon. Brexit now requires all devices shipped to the UK after June 2023 to carry a UKCA marking.
Moreover, products shipped to Northern Ireland from 1 January 2021, where conformity assessments are done in the UK, will need to carry a new UKNI marking. Every impacted label will need to be identified, updated and approved. Other countries, including China and Australia, are also implementing requirements similar to EU MDR.
Volumes of Class II and Class I device labelling and IFU changes will have an overwhelming impact on organisations that fail to embrace change and a move towards technology-based solutions.
Lost time can still be recovered, but only if organisations act now. Delaying action and investment until the second wave of EU MDR hits is certain to result in major disruption, lost revenue and, potentially, serious consumer harm.
