Module 19: Regulation of In Vitro Diagnostic Medical Devices

28/03/2023

45

EU declaration of conformity IVDR Article 17.2

“2. Where, concerning aspects not covered by this Regulation, devices are subject to other Union legislation … a single EU declaration of conformity shall be drawn up in respect of all Union acts applicable to the device …“

Example: If an electrical IVD also has to comply with RoHS* (Restriction of Hazardous Substances), a CE marking directive.

*Directive 2011/65/EU, as amednded

The Organisation for Professionals in Regulatory Affairs

45

46

IVDR Annex IV ‘The EU declaration of conformity shall contain the following information’:

‘Name, registered trade name or registered trade mark and, if already issued, SRN … of the manufacturer, and, if applicable, its authorised representative, and the address of their registered place of business …;

A statement that the EU declaration of conformity is

issued under the sole responsibility of the manufacturer;’

The Organisation for Professionals in Regulatory Affairs

46