Change up ahead: How medical device manufacturers can prepare for new regulations

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Change up ahead: How medical device manufacturers can prepare for new regulations

November 27, 2020

1. Identification and traceability requirements demand more than manual processes
Incorrect labeling means products do not have the required transparency as they move through the supply chain to the patient – incidents such as the PIP breast implant scandal of 2009/2010 could still wreak havoc. This is what MDR is designed to avoid.

Under MDR, everything from bandages and crutches to digital patient monitoring devices, contraceptive implants, hearing aids and pacemakers will need to carry a unique device identifier (UDI) on all of its labeling, enabling rapid lookup in the event of an issue. Faulty batches of products can be pinpointed and tracked down in the market for targeted remedial action – but this depends on accurate, consistent and reliable labeling.

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On top of traceability, the stringent new measures under MDR demand that information is logged in a huge central EU database, EUDAMED – a prerequisite for marketing medical devices in European markets. Products must be correctly labeled with specified safety information and symbols and meet requirements around electronic IFUs. Devising a more defined strategy for enterprise labeling and artwork is critical.

Any change to labeling can threaten the quality and reliability of what is issued, as even simple adjustments can throw out the layout, leave a barcode partially missing or obscure critical wording. So, it is imperative that manufacturers are not still relying on ad-hoc manual processes for ensuring that all ensuing output meets the new regulations consistently and definitively.

2. Under the new regulation, consistency will be key
Clear visibility, control and systematic coordination across everything included on or with their products will be essential if manufacturers want to keep abreast of identification and traceability demands.

In the run-up to MDR compliance, many manufacturers will realize their internal systems are not up to the task of handling the new EU requirements across global operations. Although the responsible teams at these companies know what they have to do, getting the right labels out onto products and packaging is a big challenge when manufacturing and distribution operations span locations in the Far East and U.S., as well as Europe itself.

The only way to ensure consistency and reliability across all channels and markets is to digitize the labeling process and have a single source of labeling ‘truth’ that all market-facing product information and materials flow from. In other words, one definitive place to update and check everything – which any authorized team can access, anywhere in the world, supported by appropriate controls governing who can do what to and with the content assets.

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