As part of a continued focus on sustainability, the European Commission, Council, and Parliament reached a provisional agreement on the Ecodesign for Sustainable Products Regulation (ESPR) in early December 2023. The new regulation will build on the …
U.S. product recalls fell more than 10% in the third quarter of 2023, the largest quarterly decline recorded in over three years according to Sedgwick’s latest Recall Index report. Despite this decrease, 2023 still remains on track to hit a five-year…
The number of European product recalls increased in the third quarter of 2023 for the fifth consecutive quarter, according to Sedgwick’s latest European Recall Index report. Across the five industries tracked in the report, there were 3,227 recalls i…
Regulators, lawmakers and technology experts alike seem to agree on two things: artificial intelligence (AI) is an important piece of our future and it needs guidelines for its use. Across the globe, there has been a recent flurry of activity ranging…
After largely pausing onsite facility inspections during the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) has resumed this type of oversight in the past 18 months. However, several recent in-market events involving contaminated eye …
Frustration with the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) continues to mount among industry stakeholders over a lack of quick and economical regulatory approval processes. Since the inaction has resulted in s…
Responding to stakeholder concerns, the U.S. Food and Drug Administration (FDA) announced that it will establish a one-year stabilization period for the Drug Supply Chain Security Act (DSCSA) traceability requirements to ensure continuity of the supp…
The U.S. Food and Drug Administration (FDA) continues to work through the redesign of its organizational structure into one unified Human Foods Program (HFP) and recently highlighted its dietary supplements program as a critical priority. In an upd…
In late August, UK Members of Parliament criticised the UK government for failing to lead in regulating artificial intelligence (AI). The criticism came ahead of an AI summit the UK government is hosting in November, and followed the release of a gov…
The risk of product recalls across five key industries remains prevalent in the U.S. according to data from Sedgwick’s latest Recall Index report. Despite recall activity falling less than one percent in Q2 2023 compared to the previous quarter, at o…
European product recalls increased 7.8% in the second quarter of 2023, marking a fourth consecutive quarter of aggregate growth across the automotive, food and beverage, pharmaceutical, medical device and consumer product sectors. According to Sedgwi…
In early August, the government of the United Kingdom released 13 proposals to change product safety. While stakeholders have been expecting these proposals for a while now, a few of the changes came as a surprise to regulatory experts because they c…
The U.S. National Highway Traffic Safety Administration (NHTSA) indicated that it plans to publish a notice of proposed rulemaking on automated driving systems (ADS) this fall. Simultaneously, several members of the U.S. House of Representatives are …
Last month, the European Academy of Paediatrics and 22 other medical associations wrote a letter to the EU Health Commissioner, urging the correction of the new EU Medical Devices Regulation (MDR). They warned that the regulation has led to a shortag…
As technology rapidly evolves, cybersecurity has become indispensable in many industries. As the risk of cyberattacks infiltrates the healthcare industry, U.S. Congress is pressured to take action. As a range of medical devices — IV pumps, MRI …