Updates

Amendments to Harmonised Standards for Medical Products

In this article...

The European Commission issued Implementing Decision (EU) 2024/815, amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for medical.

On 6 March 2024, the European Commission issued Implementing Decision (EU) 2024/815, which amends Implementing Decision (EU) 2021/1182. This update pertains to harmonised standards for several critical aspects of medical products, including:

  • Medical Gloves for Single Use
  • Biological Evaluation of Medical Devices
  • Sterilization of Health Care Products
  • Packaging for Terminally Sterilized Medical Devices
  • Processing of Health Care Products

The List of Standards is available in our library. Also, the database of standards is updated and now includes the updates.