Harmonised standard

Meeting a harmonised standard cited in the Official Journal presumes conformity with the MDR or IVDR requirements it covers, and its Z annexes show which ones. Using harmonised standards is voluntary; other solutions are allowed if they are justified.

‘harmonised standard’ means a European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012;

EU MDR, Article 2(70)

‘harmonised standard’ means a European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012;

IVDR, Article 2(73)