The Sedgwick brand protection recall index is the essential reference for medical device manufacturers seeking impartial and reliable perspective on past, present, and future product recall data and safety trends.
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Contact usThe latest edition of our highly coveted product recall index report offers a comprehensive year-in-review of 2021 medical device product recall data and trends, and insightful predictions for the remainder of 2022. It is the only report of its kind that aggregates and tracks essential data to help medical device business leaders mitigate litigation and reputational damage caused by product recalls and other in-market product incidents.
While we strongly recommend you download and read the whole index, the following excerpt provides a glimpse into the key insights and analysis from the medical device sector.
medical device recalls rose in 2021
recall events in 2021
leading cause of recalls
The medical device industry continued to prepare for changes to the transition periods required to take in vitro diagnostic (IVD) medical devices to market in 2021. IVDs are tests used on biological samples to determine the status of a person's health. They include both self-administered tests such as those for pregnancy or blood glucose levels, and more complex testing performed in clinical laboratories. HIV tests and COVID-19 tests are also examples of IVDs. New rules were expected to go into effect in May 2022, but that deadline was extended and amended by EU lawmakers to avoid shortages of critical medical products that may be subject to delays under the new transition periods.
The EU also took steps to address medical device shortages, granting the European Medicines Agency (EMA) the ability to create and manage a European Shortages Monitoring Platform to streamline the collection of information on shortages and the supply and demand of medicinal products. UK regulators, specifically the Medicines and Healthcare products Regulatory Agency (MHRA), also took more aggressive regulatory steps in 2021 as industries adjusted to Brexit and changes in regulations. These new regulations will likely continue to impact businesses inside and outside the UK in 2022 as companies adjust to the post-Brexit landscape.
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Download the reportThe volume of product recalls in the medical device category rose sharply in 2021 compared to the previous year – up 40% to 2,886. Quality issues were the most common reason listed for medical device recalls throughout the year, accounting for 21.8% (630) events. Software was the leading cause of product recalls in Q3 and Q4 and finished the year as the second most common reason for medical device recalls with 408, followed by sterility (275).
Germany was the top country for notifications, followed by Italy and France. In terms of country of origin for recalled medical devices, the same three countries topped the list. While there were no medical devices recalled in Europe that originated in the United States in the first half of 2021, there was a jump in the second half of the year to finish with 169 events.
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Get unrivaled analysis and perspective on the latest medical device product safety trends and regulation.
Download the reportWhile product recall numbers are important, they are only part of the story. Here's what you should take away from medical device product safety developments in 2022:
Recall index report
Get unrivaled analysis and perspective on the latest medical device product safety trends and regulation.
Download the reportWhether you’re planning for — or currently facing — a product recall, market withdrawal or any other in-market product incident, our experts are on hand to support you.
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