Lessons from EU Medical Device Regulation compliance preparations
As new device identification and traceability measures become compulsory in 2020 under MDR, Kallik’s Bob Tilling explores the outstanding labelling challenges for manufacturers.
From May 2020, new medical devices sold in the EU must comply with new Medical Device Regulation (MDR) requirements. So how well prepared are manufacturers as the deadline approaches, and what challenges remain?
1. Starting from scratch: the pain of playing catch-up
Many medical device manufacturers have been caught off-guard by just how demanding this wholescale process change can be. Preparing for MDR has been a colossal catch-up exercise for them. Up to now, compared to the pharmaceutical and biotech sectors, the medical device industry has been subject to more relaxed controls over device identification and traceability, and product lifecycle monitoring and reporting. This, added to the relative size of many of the firms involved, has meant processes such as global labelling management have not been a board-level priority.
But that must change now as disjointed approaches to preparing different types of labelling output does not lend itself well to the kinds of controls the EU is now imposing.
2. The centrality of labelling
In the event of a safety scare and potential product recall, it is no longer sufficient for patients and their medical consultants or pharmacy outlets to know which type of device has been affected. It must be possible to swiftly pinpoint and track down faulty batches of product in the market, for targeted remedial action. This in turn depends on consistently-reliable labelling.
Incidents like the PIP breast implant scandal of 2009/2010, which triggered all of the new safety measures coming through now, could still wreak havoc. This is what MDR is designed to avoid.
3. Consolidated control & holistic visibility as critical success factors
Manufacturers cannot hope to keep on top of product identification and traceability, or manage this with rigour and efficiency, if they do not have clear visibility, control and systematic coordination across everything included on or with their products - through every channel, in every market.
The only way to ensure consistency and reliability is to have a single global source of labelling ‘truth’ that all market-facing materials flow from; one definitive place to update and check everything - which any authorised team can access, anywhere in the world, supported by appropriate controls governing who can do what to and with the content assets.
4. Integrating & harmonising processes takes time
Arguably the most significant impact MDR has had on manufacturers relates to the scale of work involved. Many companies have drastically underestimated this. The danger, where companies have left MDR preparations until the eleventh hour, is that they are forced by time pressures to do the minimum required for compliance, compromising the internal business benefits.
5. Change is a constant
Another sobering realisation has been that regulatory disruptions are not a one-time event. Any companies that haven’t taken the time to do things properly this time around, then, face having to go through new upheaval next time new international requirements are introduced.
For instance, from May 2021 unique device identifier (UDI) codes/detailed product serialisation information will have to appear on all product labelling, which present further challenges for device manufacturers lacking a structured way of managing this.
It is important to keep in mind the bigger picture here – which is about ensuring patient safety and trust. The specific requirements of MDR are just part of this wider vision, so manufacturers should not be limited by them in their efforts to overhaul their approach to global labelling management.
Bob Tilling is New Business Development Manager at market-leading enterprise labelling company Kallik. www.kallik.com