2 docs tagged with "ce-marking"

MDR conformity assessment procedures are set out in MDR Art. 52 and Annexes IX–XI. IVDR equivalents are in IVDR Art. 48 and Annexes IX–XI. The EU Declaration of Conformity is required under MDR Art. 19 / IVDR Art. 17 and MDR Annex IV / IVDR Annex IV.

MDR Art. 19 and Annex IV (Declaration of Conformity); MDR Art. 20 (CE marking). Equivalent IVDR provisions: Art. 17 and Annex IV (DoC); Art. 18 (CE marking).