European medical device recalls increase by 11%

September 16, 2022

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Sedgwick brand protection releases latest European product recall index report for Q2

LONDON, 16 September 2022 – Sedgwick brand protection published their latest European product recall index report for Q2. Medical device recall increased to 719 events in this year’s second quarter, up 11% from 649 events in Q1 and 7% from 670 recalls in Q2 of 2021.

Both the EU and the UK have introduced new regulations for medical devices, but a shortage of accredited organizations to assess the products’ conformity with EU standards before they can be marketed is creating challenges for manufacturers.

After a five-year transition period, the EU promulgated its In Vitro Diagnostic Medical Devices Regulation (IVDR) in May. Meanwhile, the UK released its own comprehensive strategy for medical device regulation. The proposal looks at 15 different areas for improving patient safety and spurring innovation.

Between September and November 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) asked for input on its consultation around proposed changes to the regulatory framework for medical devices in the UK. As part of its new plan, the MHRA intends to increase safety standards by making medical device manufacturers, importers and distributors more accountable. It also supports the use of Unique Device Identifiers (UDIs) for medical devices sold in the UK and the creation of a more comprehensive device registration database.

To download the latest report, visit European product recall index report.

Q2 2022 medical device recall highlights:

  • The number of medical device recalls increased to 719 in Q2 2022, up 11% from last quarter. This is higher than both the 649 events in Q1 2022 and the 670 recalls in Q2 of 2021.
  • For the fourth quarter in a row, software issues were the most common reason for medical device recalls. They were cited in 81 events, on par with the 82-last quarter.
  • Safety issues and device failure each accounted for 72 recalls in Q2 2022, with false results linked to 67 events.
  • Germany continued to have the most recall notifications, with 206 in Q2, roughly the same as the 209 from Q1 2022. France was second with 193 notifications, up 11%. Italy was third with 185 notifications, up 23% from the previous quarter. The UK had only one notification in Q2.

“Manufacturers seeking to sell certain medical devices throughout Europe now face a frustrating regulatory environment and unsettled market, especially if they haven’t used the transition period to adequately prepare. The data shows an ongoing uptick in recalls that the expected new rules are seeking to address,” said Mark Buckingham, international product recall consultant at Sedgwick.

“In the UK, safety issues continue to be a primary cause of product recalls and it’s crucial that manufacturers closely observe that any new statutes align with the recommendations described in the MHRA response and comply with international rules and standards,” Buckingham added.

The recall index is the industry’s leading research and analysis produced quarterly by Sedgwick’s experts in best practice product recall and remediation solutions. It is an essential reference for manufacturers and retailers seeking impartial and reliable perspective on past, present and future recall data and product safety trends.

For more information on Sedgwick brand protection, visit

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