IVDR Conformity Assessment Procedure

 Conformity assessment is a procedure which demonstrates that device in compliance with MDR.

Notified body (NB) is a conformity assessment body that performs third-party conformity assessment activities including calibration, testing, certification and inspection.

Every manufacturer needs to undertake an assessment of the conformity of that device.

Conformity assessment Annexes are listed below,

1.ANNEX IX CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION

v  CHAPTER I QUALITY MANAGEMENT SYSTEM(QMS)

v  CHAPTER II ASSESSMENT OF THE TECHNICAL DOCUMENTATION(TD)

v  CHAPTER III ADMINISTRATIVE PROVISIONS (Record Retention)

EU Quality management system certificate , EU technical documentation assessment certificate

2.ANNEX X CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION

Product based EU type-examination certificate

3.ANNEX XI CONFORMITY ASSESSMENT BASED ON PRODUCTION QUALITY ASSURANCE

EU Quality assurance certificate

Manufacturer can select conformity assessment route based on device class. IVDR CHAPTER V CLASSIFICATION AND CONFORMITY ASSESSMENT, Article 48 of SECTION 2 Conformity assessment explains the various conformity assessment routes as given below.

Class D:

1.     Option 1: Annex IX*.

2.     Option 2: Annex X Production quality assurance

*Chapter II section 5.1 is applicable for only devices used for self-testing and near-patient testing

Companion diagnostics: NB consultation with a competent authority or the EMA per Section 5.2 of Annex IX or Section 3 of Annex X.

EU reference laboratories shall verify the performance claimed by the manufacturer and the compliance of the device with the applicable CS, or with other solutions

Class C:

1.     Option 1: Chapters I QMS and III of Annex IX + Chapter II* Assessment of the technical documentation (TD). Sections 4.4 to 4.8 -TD assessment for at least one representative device per generic device group.

2.     Option 2: Annex X + Annex XI Production quality assurance except its Section 5.

*Chapter II section 5.1 is applicable for only devices used for self-testing and near-patient testing

Companion diagnostics: NB consultation with a competent authority or the EMA per Section 5.2 of Annex IX or Section 3 of Annex X.

Class B:

Option : Chapters I QMS and III of Annex IX + Chapter II* Assessment of the technical documentation (TD). Sections 4.4 to 4.8 -TD assessment for at least one representative device for each category of devices.

*Chapter II section 5.1 is applicable for only devices used for self-testing and near-patient testing

Class A Sterile:

Procedures set out in Annex IX or in Annex XI. NB involvement shall be limited to the aspects relating to establishing, securing and maintaining sterile conditions.

Class A:

1.     Class A device shall have TD as per Annexes II and III.

2.     Self-certification without involving any Notified body

Devices for performance studies shall be subject to the requirements set out in Articles 57 to 77.

Click below link to know more about MDR Conformity Assessment Procedure :https://meddev-info.blogspot.com/2021/01/mdr-conformity-assessment-procedure.html

Source: REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU