Lessons and leftover challenges from MDR preparations

The stringent new measures under MDR/IVDR require robust end-to-end product traceability, and that information is logged in a huge central EU database, EUDAMED – a prerequisite for marketing medical devices in European markets. This in turn requires that products are correctly labelled with specified safety information and symbols, and meet requirements around electronic IFUs. So, devising a more defined strategy for enterprise labelling and artwork is critical.

Device identification is a critical element in all of this. 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 device has been affected. To limit the damage, fear and hysteria, not to mention the cost to the manufacturer and the impact on their brand reputation, it is important that faulty batches of product can be pinpointed and tracked down in the market, for targeted remedial action. This in turn depends on consistently-reliable labelling.

If the correct label is not fixed to the right product at the right time, products will not have the required transparency as they move from factories, through distribution, to the hospitals, doctors’ surgeries and pharmacies who supply them, and the recipient patients. 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.

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.

In the final countdown to MDR compliance, 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; 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.

Arguably the most significant impact MDR has had on medical device manufacturers relates to the scale of work involved. Many companies drastically underestimated this, leaving projects too late. Dispersed teams and disjointed processes, as well as inevitable duplication between content sources such as translation databases (for instance where these have existed separately for label and IFU creation), make for highly complex scenarios that take time to unravel. That’s before improvements can be implemented to streamline and (where possible) automate processes, such as change management.

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, even if that is a costly workaround that doesn’t deliver the quality control, compliance confidence or process efficiencies the manufacturer needs.