The conformity assessment procedure is governed by Articles 52 and 54 and by Annexes IX–XI to EU-MDR58, taking account of the amendments to Article 52, paragraph 4, sub-paragraph 2 EU-MDR adopted by the European Commission by means of delegated acts59.
58 See the footnote to Art. 4 para. 1 let. f.
59 See Annex 4.