detected 2026-08-12 MODIFIED+61 −62§
no amending act named
applies from: unchanged
In paragraph 7, the reference to an assessment of the technical documentation specified in Sections 4.4 to 4.8 of Annex IX was replaced with a reference to an assessment of the technical documentation specified in Section 4 of that Annex.
The same substitution was made in paragraph 9, changing the cited technical documentation sections from Sections 4.4 to 4.8 of Annex IX to Section 4 of that Annex.
Cited: Art. 48, v2
text before / after
32017R0746 → 02017R0746-20170505
Article 48
Conformity assessment procedures
1. Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI.
2. Prior to … 561 unchanged words … of the scientific opinion by the EU reference laboratory as specified therein.
7. Manufacturers of class C devices, other than devices for performance study, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, including and, in addition, to an assessment of the technical documentation as specified in Sections 4.4 to 4.8 Section 4 of that Annex of for at least one representative device per generic device group.
In addition to the procedures referred to in the first subparagraph, for devices for self-testing and near-patient testing, the manufacturer shall follow the procedure for technical documentation assessment set out in Section 5.1 of Annex IX.
In addition to the procedures referred to in the first and second subparagraphs, for companion diagnostics the notified body shall for every device follow the procedure for technical documentation assessment laid down in Section 5.2 of Annex IX, and shall apply the procedure for technical documentation assessment laid down in Sections 4.1 to 4.8 of Annex IX and shall consult the competent authority designated by the Member States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the procedure set out in Section 5.2 of Annex IX.
8. Manufacturers of class C devices, other than devices for performance study, may, instead of the conformity assessment procedure pursuant to paragraph 7, choose to apply a conformity assessment as specified in Annex X coupled with a conformity assessment as specified in Annex XI except its Section 5.
For companion diagnostics the notified body shall in particular for every device consult a competent authority designated by the Member States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the procedure set out in point (k) of Section 3 of Annex X.
9. Manufacturers of class B devices, other than devices for performance study, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and including and, in addition, to an assessment of the technical documentation as specified in Sections 4.4 to 4.8 Section 4 of that Annex for at least one representative device per category of devices.
In addition to the procedures referred to in the first subparagraph, for devices for self-testing and near-patient testing, the manufacturer shall follow the procedure for assessment of the … 368 unchanged words … Sections 3.4 and 4.3 of Annex IX and points (f) and (g) of Section 3. of Annex X.
The implementing acts referred to in the first subparagraph shall be adopted in accordance with the examination procedure referred to in Article 107(3).