Rapid Action Required For Medtech Compliance With EU Batteries Regulation

As deadlines approach, the regulatory landscape for medtech batteries is set to change, with an emphasis on sustainability and ethical practices.

Man self-monitoring of blood pressure with a tensiometer
Blood Pressures Monitors Are Among Devices Featuring Batteries • Source: shutterstock.com (Shutterstock)
Key Takeaways
  • Due diligence requirements apply from 18 August 2025
  • Removability and replaceability guideline ready ahead of February 2027 deadline
  • No notified bodies have been named yet under the Batteries Regulation

Medtech manufacturers and other economic operators have until 18 August 2025 to comply with due diligence requirements and ensure responsible sourcing and ethical practices as part of the extended producer responsibility requirements under the new

It will apply only to those marketing of devices that require battery-derived energy with a turnover exceeding €40m ($43m), meaning that small innovative companies in the medtech sector

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