Path to EU Market Entry: Conformity Assessment Procedures

Path to EU Market Entry: 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- Option 1

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- Option 2

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 ALL Class D (regardless of above chosen path)

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- Option 1

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 - Option 2

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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