Discrepancies in product classification are becoming a big challenge for the channel, says Farzad Henareh, European vice president at Stericycle ExpertSolutions…
In the complicated global supply chain, all stakeholders, manufacturers, suppliers, disties and regulators must take ownership of product safety.
It is not unusual to see technology companies recalling products for a range of reasons, but one of the most challenging to manage is the discrepancies in product classification.
Products across all sectors – from consumer goods to food – are subject to recalls. At Stericycle ExpertSolutions we publish a quarterly European Recall and Notification Index, which for Q2 2015 shows that there has been a seven per cent drop in the number of recalls overall, compared to Q1. However, safety notifications and recalls have actually been on an upward trend since 2003, with 88 per cent of them being categorised as a most serious threat.
Regulations play a considerable role in this, because although they are a crucial component of product safety, they are not consistent across Europe, nor are they enforced by one EU agency. It is the responsibility of individual EU member countries to interpret and enforce the ‘CE’ marking on required products to indicate compliance with safety legislation. But this is in accordance with national laws and procedures. These differ widely across Europe – what may be deemed safe in one country may not be in another.
A prime example can be found in the mobile applications sector. According to a recent report from the Deloitte Centre for Health Solutions, there are currently over 100,000 medical apps available in the UK app store. Where these remind consumers to take critical medication or monitor life-threatening conditions, they can revolutionise people’s approach to health and wellness.
However, developers must be aware of the regulations governing them. The Medicines and Healthcare Products Regulatory Agency, which is responsible for governing medical devices in the UK, and the European Commission, have issued guidance on whether a healthcare app can be considered a medical device based on keywords. Apps that are intended to ‘diagnose’ or ‘monitor’ fall under the medical device category, while those that remind patients of medical appointments are considered consumer applications. Imagine the potential for confusion and safety issues, if apps don’t fit neatly into these two categories, and inevitably, the impact of incorrect classification and a recall on consumers.
The Government is currently reviewing the UK’s system for the recall of unsafe products under consumer champion, Lynn Faulds Wood, and the classification issue is sure to be high on the agenda. In the meantime, our evolving product environment with emerging technologies and devices, new regulations and country-specific requirements, demands that all of us have to remain vigilant and do our bit to keep consumers safe.
Farzad Henareh is European VP at Stericycle ExpertSolutions, which focuses on managing automotive and consumer products. www.stericycleexpertsolutions.com