Conformity Assessment Procedures

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 of the IVDR.

Class D Conformity Assessment Procedures

Class D first option

Manufacturers of class D devices, other than devices for performance study, shall be subject to a conformity assessment as specified in Chapters I, II and III of Annex IX (Conformity assessment based on a quality management system and on assessment of technical documentation).

  • In addition, 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, for companion diagnostics the manufacturer shall follow the procedure for technical documentation assessment set out in Section 5.1 of Annex IX. Furthermore, the notified body shall consult a competent authority designated by the Member States in accordance with Directive 2001/83/EC of the European Parliament and of the Council or the EMA, as applicable, in accordance with the procedure set out in Section 5.2 of Annex IX.

Class D second option

Manufacturers of class D devices, other than devices for performance study, may choose to apply a conformity assessment as specified in Annex X coupled with a conformity assessment as specified in Annex XI.

  • For companion diagnostics, the notified body shall in particular 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.

For Class D regardless of above option chosen

For devices for which one or more EU reference laboratories have been designated in accordance with Article 100, the notified body performing the conformity assessment shall request one of the EU reference laboratories to verify by laboratory testing the performance claimed by the manufacturer and the compliance of the device with the applicable Common Specifications, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent.

In case where no Common Specifications are available for class D devices and where it is also the first certification for that type of device, the notified body shall consult the relevant panel of experts referred to in Article 106 of Regulation (EU) 2017/745 on the performance evaluation report of the manufacturer.

Class C Conformity Assessment Procedures

Class C first option

Manufacturers of class C devices shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, including an assessment of the technical documentation of at least one representative device per generic device group.

  • In addition 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 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.

Class C second option

Manufacturers of class C devices, may 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,.

Class B Conformity Assessment Procedure

Manufacturers of class B devices shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and including an assessment of the technical documentation for at least one representative device per category of devices.

  • In addition for devices for self-testing and near-patient testing, the manufacturer shall follow the procedure for assessment of the technical documentation set out in Section 5.1 of Annex IX.

Class A conformity Assessment Procedure

Manufacturers of class A devices shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 17, after drawing up the technical documentation set out in Annexes II and III.

  • However, if those devices are placed on the market in sterile condition, the manufacturer shall apply the procedures set out in Annex IX or in Annex XI. Involvement of the notified body shall be limited to the aspects relating to establishing, securing and maintaining sterile conditions.

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