Technical Documentation

Technical Documentation

Manufacturers shall draw up and keep up to date the technical  documentation for those devices. The technical documentation shall be such as to allow the conformity of the device with the requirements of  this Regulation to be assessed. The technical documentation shall  include the elements set out in Annexes II and III of the authorised representative IVDR.

The Technical Documentation shall contain all evidences to demonstrate that an in vitro diagnostic device complies with the general safety and performance requirements specified  in Annex I of the authorised representative IVDR. The Technical Documentation is mandatory for  all devices regardless of their classification (A, B, C or D).

Manufacturers  shall keep the technical documentation, the EU declaration of  conformity and, if applicable, a copy of the relevant certificate,  including any amendments and supplements, available for the competent  authorities for a period of at least 10 years after the last device  covered by the EU declaration of conformity has been placed on the  market.

Upon request by a competent authority, the manufacturer  shall, as indicated therein, provide that technical documentation in its  entirety or a summary thereof.

A manufacturer with a registered  place of business outside the Union shall ensure that the authorized  representative has the necessary documentation permanently available.

Manufacturers  shall, upon request by a competent authority, provide it with all the  information and documentation necessary to demonstrate the conformity of  the device, in an official Union language determined by the Member  State concerned.

The Member State in which the notified body is  established may require that all or certain documents, including the  technical documentation, audit, assessment and inspection reports,  relating to the procedures referred to in paragraphs 1 to 10 be made  available in an official Union language(s) determined by that Member  State. In the absence of such requirement, those documents shall be  available in any official Union language acceptable to the notified  body.

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