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.
- The Regulation: IVDR 2017/746/EU
- Path to EU Market Entry: Conformity Assessment Procedures
- Notified Bodies under the IVDR
- Authorized Representatives under the IVDR
- Clinical Evidence and Performance Evaluation
- Clinical Performance Studies
- Person Responsible for Regulatory Compliance
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