Module 19 2021

24/05/2021

Conformity

• Article 17 – EU declaration of conformity – statement that a device conforms with all the relevant requirements of the IVD Regulation. • Conformity assessment procedures are detailed in Annexes IV*, IX, X and XI of the IVDR. • Legal manufacturer chooses the appropriate conformity assessment route (Annex) which will usually include the involvement of a Notified Body to audit and verify that the device does conform to the requirements of the IVDR that apply to it. • Legal Manufacturer signs the DoC having followed the appropriate conformity assessment procedure.

* Annex IV – Declaration of Conformity

The Organisation for Professionals in Regulatory Affairs

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Involvement of a Notified Body

Device class determines Notified Body involvement Class A: Annex IV with no Notified Body involvement ● Exception: sterile Class A IVD Class B: Annex IX ● QMS audit, surveillance audit and unannounced audit ● Technical documentation (product) assessment: representative sample per category of device (not self test or near patient test) Class C: Annex IX or X + XI ● QMS audit with annual surveillance audit and unannounced audit ● Technical documentation assessment: representative sample per generic device group (not self test, near patient test or Companion Diagnostics) Class D: Annex IX or X + XI ● QMS audit with annual surveillance audit and unannounced audit ● Technical documentation assessment for each device ● Verification by Reference Lab ● Batch release managed through notified body

The Organisation for Professionals in Regulatory Affairs

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