EU Commission’s Latest Medical Device Standards Update

On 6th March, the EU Commission published Decision EU 2024/817 and Decision EU 2024/815. These two decisions focused on updating the list of harmonized standards.

Amendment to harmonized standards in EU Medical Device Regulations

Implementing Decision (EU) 2024/815 amending Implementing Decision (EU) 2021/1182 as regards harmonized standards for medical gloves for single use, biological evaluation of medical devices, sterilization of health care products, packaging for terminally sterilized medical devices and processing of health care products.

This decision adds the following standards to the list of harmonized standards:

• • EN 455-3:2023
  • EN ISO 10993-15:2023
  • EN ISO 10993-17:2023
  • EN ISO 10993-18:2020
  • EN ISO 11137-2:2015
  • EN ISO 11607-1:2020
  • EN ISO 11607-2:2020
  • EN ISO 17664-2:2023

Implementing Decision (EU) 2024/817 amending Implementing Decision (EU) 2021/1195 as regards harmonized standards for medical gloves for single use, biological evaluation of medical devices, sterilization of health care products, packaging for terminally sterilized medical devices and processing of health care products.

This decision adds the following standards to the list of harmonized standards:

• • EN ISO 11137-2:2015
  • EN ISO 11607-1:2020
  • EN ISO 11607-2:2020

You can view the full proposals here and here.

Competent Authorities and Notified Bodies will now expect these standards to be met for medical devices and IVDs to which they are applicable.

If you need help in understanding how these updates impact your medical device or IVD, or need support in meeting the required standards, please don’t hesitate to contact us.

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