Health

#32026D1231R(01)Corrigendum on the application date for EU medical device harmonised standards

🇪🇺European Union··Other·Low Impact·View source ↗

AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.

🇬🇧 English

This corrigendum changes one date in the EU decision on harmonised standards for medical devices: Point (5) of the Annex will apply from 17 June 2031, not 15 June 2031.

AI-generated summary. May contain errors. Refer to official sources for legal decisions.

Key Changes

  • Corrects the application date for Point (5) of the Annex.
  • Replaces 15 June 2031 with 17 June 2031.
  • Does not change the substance of the medical device standards decision.

Obligations

What this law requires

low

Apply Point (5) of the Annex to Commission Implementing Decision (EU) 2026/1231 from 17 June 2031, instead of 15 June 2031.

Entities relying on or applying EU harmonised standards for medical devices under Commission Implementing Decision (EU) 2026/1231
operational

Affected Parties

Medical device manufacturersCompliance teams using EU harmonised standards

Tags

medical devices,harmonised standards,corrigendum