Module 19 2021

24/05/2021

Conformity assessment options

A B

C

D

EU Declaration of Conformity Annex IV*

Quality Management

Quality Management

Quality Management

Type Examination Annex X (includes Technical Documentation)

Type Examination Annex X (includes Technical Documentation)

System Assurance Annex IX Ch I & III

System Assurance Annex IX Ch I & III

System Assurance Annex IX Ch I & III

* Except sterile

Assessment of Technical

Assessment of Technical

Assessment of Technical Documentation * Annex IX Ch II

Production Quality Assurance Annex XI

Production Quality Assurance Annex XI

Documentation per category device § - Annex IX Section 4

Documentation per generic device § - Annex IX Section 4

* Assessment of technical documentation - Class D, Class B, C, D self test and near patient tests and Companion Dx

For Companion Diagnostics CA consultation Annex IX 5.2 §

For Companion Diagnostics CA consultation Annex X 3

Verification by EU Reference Laboratory

Verification by EU Reference Laboratory

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Definitions from MDCG 2019-13

MDCG 2019-13 is the guidance issued for sampling of IVDs for assessment of technical documentation. Allows manufacturers to group together Class B and C devices for the purpose of technical documentation review.

Category of Device – As defined by the relevant IVR codes according to Regulation (EU) 2017/2185 designation codes for Notified Bodies

Generic Device Group – 3rd level of the EMDN (one letter (W) plus 4 digits with the most appropriate IVP code. MDCG 2019-13 Guidance also allows manufacturer and NB to group using 4th level (W + 6 digits)

Only Generic Device Group is actually defined in the IVDR – having the same or similar intended purpose or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics

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