EU MDR: The final countdown

Bob Tilling, new business development manager at enterprise labelling company, Kallik, explores the issues that compliance preparations have raised for manufacturers – particularly in relation to global labelling management.

When the EU Medical Device Regulation (MDR) comes in to force, new medical devices sold in the EU must comply with the new MDR requirements. The exception is certain low-risk medical devices currently classified as class I, which are set to be moved into a higher-risk class under the MDR at a later date, since they have been granted an extended transitional period.

Much has been written already about the phasing in of MDR, and the in vitro device equivalent - In Vitro Diagnostic Regulation (IVDR). But what challenges remain for all classes of medical devices getting ready for MDR?

Playing catch up

Many medical device manufacturers have not factored in just how demanding this wholescale process change is. Preparing for MDR has involved playing catch up to a large extent. Up to this point, and in comparison with the pharmaceutical and biotech sectors, the medical device industry has been bound by relatively relaxed controls over device identification and traceability, and product lifecycle monitoring and reporting. This, as well as the relative scale of many of the firms involved, has meant processes such as global labelling management have not been a board-level priority.

Physical labels have tended to be created as templates and printed manually on the factory floor using data from Enterprise Resource Planning (ERP) systems, while other customer-facing materials such as Instructions For Use (IFU) leaflets come under the remit of separate teams - even external design agencies. This lack of a joined up approach has impeded the industry’s MDR preparations, as the EU requires systematic process co-ordination and content uniformity.

The pivotal role of labelling

In the event of a safety scare and potential product recall, it is not enough for patients and their medical consultants or pharmacy outlets to know which type of devices are affected. To limit the harm and manage the fears and hysteria, as well as cap the cost to the manufacturer and minimise the impact on their brand reputation, it is important that faulty batches of products can be accurately identified and tracked down 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 generated all of the new safety measures that have recently come in, have the potential to create enormous damage. This is what MDR is designed to put an end to.

Consolidated control and visibility

Organisations now realise that the only way to ensure consistency and reliability is to have a single global source of labelling ‘truth’ that all market-facing product information and materials flow from; namely, one single place to update and check everything - which any authorised team can access, anywhere in the world, supported by appropriate limits on who can do what to and with the content assets.

The perils of eleventh hour preparation

The most significant impact MDR has had on manufacturers relates to the scale of the work involved. Many companies have radically underestimated the resource and time required. 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. Worse, it’s a costly workaround that doesn’t deliver the quality control, compliance confidence or process efficiencies the manufacturer needs. This is clearly less applicable to device manufacturers in the class I bracket, since they now enter a transitional period. But experts caution this shouldn’t mean that these manufacturers should be lulled into a false sense of security and so slow their preparations to any great degree. What’s more, the class I extension has no impact on timescales for device manufacturers to include the device identifier and appropriate symbols mandated by the EU on their labels.

More regulation on the horizon

Another sobering realisation has been that regulatory disruptions are not – or certainly won’t be - a one-off event. Any companies that haven’t taken the time to do things properly this time around face having to go through new upheaval the next time new international requirements are introduced.

For instance, from May 2021 unique product identifier codes/detailed product serialisation information will have to appear on all product labelling – so there is a lot to get right in the coming months and years and having a structured way of managing this will be critical.

The specific requirements of MDR are just part of this bigger picture, which is about ensuring patient safety and restoring public trust in the industry and its product - so manufacturers should not be limited by them in their efforts to streamline their approach to global labelling management.