Glossary

Harmonised standard [MDR/IVDR]

MDR IVDR

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

[Definition under (EU) 2017/745 Article 2 No. 70 also corresponds to definition under (EU) 2017/746 Article 2 No. 73]

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