Do your homework to avoid a sticky situation, says Mark Cusworth, VP Research and Development, PRISYM ID. Here he examines the EU Medical Device Regulation and its implications on labelling – and looks ahead to the future and the predicament companies will begin to face unless they start to make changes now
The labelling of medical devices is an already complex process, but it’s only set to become more complicated for the medical device manufacturers that do business in Europe. New medical device regulations (MDR) are coming into place that dictate numerous requirements that anyone involved in the design, manufacture, approval and commercialisation of devices that are sold in the EU must adhere to. And although full adoption is not expected until 2020, the clock is ticking, and many requirements need to be in place now.
Replacing the old EU Medical Device Directive, the EU MDR is a new regulation that governs the production and distribution of medical devices. Due to this, medical device companies – and their external partners – are now forced to review the processes and systems which hit every touch point of their operations.
Since going live at the end of last year, the European Database for Medical Devices (EUDAMED), has acted as the catalyst for the influx of labelling challenges, which if aren’t addressed, could fundamentally block businesses from selling their devices in Europe. Essential to the functioning of the MDR, the EUDAMED requires device registrations to be submitted to them in order to permit sale in the EU. This process necessitates company compliance to the new specific requirements surrounding labelling content. These include, but are not limited to, labelling requirements around: single-use devices, clinical investigation, hazard warnings, electronic labelling, electronic IFUs and the future introduction of mandatory symbols. There are even new requirements which means company label designs need to be amended, such as the new symbol which shows if a package contains a medical device. And although many of these changes will sit in line with the US UDI, the EU however will have to adopt tighter controls than the FDA.
These changes will impact numerous touch points across the company, changing the way visibility, control and connectivity are both viewed and managed. Worryingly, a recent industry survey highlighted that half of the industry hasn’t yet begun planning for change. What is more is that the other half have not even begun thinking about the challenge ahead. There is risk ahead; and time is not on our side.
As anticipated, many organisations have begun to adopt processes that support FDA UDI in preparation for the EU’s requirements. In light of the US experience, there are a number of learnings we can take away from it that will help advise and educate the industry in time for adoption in the EU.
The impact that UDI implementation will have on operations shouldn’t be underestimated, as it will result in slowed and complicated development and deployment, which in turn will make the process more expensive. This is especially important in the case of MDR, as it is regulation which holds a larger scope, an increasingly complicated process, and greater penalties for failed compliance. Without adherence, companies will have put shipping on hold while they wait for a license; highlighting the potential ramifications if companies do not act in time.
Just like the labelling itself, UDI touches upon every aspect of a business. Due to this, it is important to keep all relevant stakeholders in mind when developing systems to support MDR compliance. In particular, building integrated teams which include stakeholders from across and outside the organisation can be chief to securing success. Essentially, establishing these groups early on and maintaining engagement with them will be the key to shaping a collaborative strategy.
It is important to look over your current system before jumping to new implementations, as your existing system may host capabilities that have gone unnoticed. With many solutions claiming to have functionalities which don’t transpire into real-world experience such as offering a ‘single source of the truth’, it is important to make sure that they will successfully integrate with your systems. Poor integration will make it difficult for users to access their data, therefore testing your company software and hardware should be a first call of action so that any uncertainties can be raised with your technology partner.
Reliable data has never been more important; adhering to the MDR means stricter rules and an increased need for all areas of enterprise data to be integrated into packaging and labelling. Understanding and trusting your data model is key to a successful implementation, however, there is still a lack of confidence when it comes to companies and their data. Knowing where your data is stored, how it’s maintained and what controls are in place is essential to maintain coherence across the board. The solutions which allow users to capture compliant data which meets all the needs of stakeholders involved is the best way of cultivating confidence in organisational data.
It is unknown what the regulatory landscape will look like tomorrow, so it is important to look long-term and build solutions that will flex with the environment. A closed view focusing on present-day requirements will only halt organisational functions when the landscape shifts, and therefore operational agility made up of continual collaboration internally and externally is crucial. This can be achieved through an industry expert technology partner who can alleviate any uncertainties by designing a system based on the fluctuating regulatory environment.
Ultimately, the best labelling solutions will ensure that label lifecycle management works in harmony from the label design process through to audit control. Access to a full view of data assets will also give medical device organisations the capabilities necessary to meet the requirements of the EU MDR. But the clock is ticking; there isn’t time to delay, companies need to act now and prepare for the changes to come or risk the alternative.
For more, read PRISYM ID’s EU MDR whitepaper.
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