Module 19 2021

24/05/2021

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

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

1.‘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 …; 2.A statement that the EU declaration of conformity is issued under the sole responsibility of the manufacturer;’

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