European Union

The EU Commission adds several product categories to its list of exemptions from consumer battery replaceability rules, citing safety and technical complexity. Learn which devices are affected and what the exemption could mean for manufacturers navigating the EU's evolving battery regulations.

The European Commission has streamlined its sustainability reporting requirements, cutting mandatory datapoints by more than 60% while promising significant cost savings for companies across the EU. See what the revised ESRS standards could mean for your organization’s compliance obligations once the review period concludes.

The EU Commission is seeking public comment on draft guidelines designed to help providers and deployers determine whether their AI system qualifies as high-risk under the AI Act — with the comment period open through June 23, 2026.

Europe's medical device notified bodies are sounding the alarm: proposed revisions to the MDR and IVDR could quietly strip away the oversight safeguards that keep patients safe. Here's what's changing — and why it matters.

The EU Commission has issued preliminary findings on TikTok’s platform design, examining how certain features may pose risks under the Digital Services Act. The ongoing investigation highlights concerns around user well‑being and potential regulatory consequences.

After years of regulatory complexity, the EU Commission offers medical device manufacturers a path forward: proposed changes limit AI Act requirements for devices, streamline risk classifications, and create efficiencies that could reduce costs and speed innovation.

The Commission of the European Union (EU) has also introduced a package of measures that it says will help to simplify existing rules and regulations in order to further support the EU’s market size and future growth.

The EU Commission is seeking public input on modernizing its product safety framework through two key initiatives: simplifying market access rules, CE marking, and conformity assessments while reducing administrative burdens, and strengthening market surveillance to help authorities better enforce compliance and prevent unsafe products from reaching consumers.

The Commission of the European Union (EU) is taking legal action to ensure that EU Member States transpose EU directives into national laws.

The government of the United Kingdom is working to align its requirements for certain medical devices with those of the European Union (EU).