Article 11 of the Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) outlines the obligations and responsibilities for the Authorised Representative (AR).
Key points are taken in accordance with the guidance:
- A ‘sole’ authorised representative means a manufacturer can have more than one AR for different generic device groups. However, for one specific generic device group, the manufacturer should designate only one AR.
- On behalf of the manufacturer, AR can lodge an application for conformity assessment according to Annex IX, X, XI MDR/IVDR with a notified body at the pre-market stage.
- AR who terminates the mandate may still cooperate with the competent authority for devices which was designated by them, particularly when no new AR has yet been designated for those devices.
- AR must be registered under EUDAMED as per Section 1 of Part A of Annex VI of the Regulations, which needs to be updated within one week of any change occurring and the accuracy of the data at intervals no later than one year after the initial submission of the information, and every second year thereafter.
- AR name shall appear on relevant documentation such as the EU DoC (Declaration of Conformity) and device labelling by the manufacturer.
- The legal representative established by the sponsor of the clinical investigation or performance study is not defined under the AR requirements.
- AR shall keep a copy of the technical documentation and the EU declaration of conformity for at least ten years after the last device covered by the EU DoC and 15 years for implantable devices.
- ‘Permanently available’ means it is mandatory for the manufacturer to provide the requisite documentation in their most recent versions and certificates. This includes amendments or supplements, either in hard or electronic copy to the AR. In practical terms having permanent access to such documents.
- When the liability of the AR is alleged within the framework of a specific legal regime for defective products, the AR is afforded the same rights to defend itself as the manufacturer under that regime.
- In the event of a problematic termination like non-compliance or non-traceability with the manufacturer, the out-going AR is also advised to inform the competent authorities and, where applicable, the notified body.
- In general, a tripartite agreement should exist, except in cases where this is ‘not practicable’ to involve the outgoing AR, the obligation under Article 12(d) to forward complaints to the manufacturer or incoming AR should apply.
- AR may be consulted for market surveillance measures taken by competent authorities to make documentation and information available to them. Also, AR may be subject to announced and unannounced inspections by the competent authorities as part of their market surveillance activities which is also covered for the legacy devices.