EAEU Updates Standards for Medical Device Compliance

The Eurasian Economic Commission (EEC) has amended its list of standards for medical device compliance within the Eurasian Economic Union (EAEU) to enhance safety and efficiency.

Key Updates:

• Newly Adopted Standards (2022-2023):
• GOST R ISO 14155-2022: Clinical investigation guidelines.
• GOST R ISO 15223-1-2023: Manufacturer information symbols.
• GOST R IEC 62366-1-2023: Usability engineering for medical devices.
• Focus Areas: Clinical research, labeling, usability, and operational documentation.
• Voluntary Implementation: While not mandatory, the standards enhance compliance and harmonization across EAEU nations.
• These updates align EAEU regulations with international best practices, promoting greater safety and efficiency in medical devices.

Region: European Union

Source: https://eec.eaeunion.org/en/news/vneseny-izmeneniya-v-perechen-standartov-dlya-soblyudeniya-sootvetstviya-medizdeliy-obshchim-trebova/