The new EU regulations for medical devices – MDR, IVDR – have introduced stricter requirements for the EU Authorised Representative. We look at the key requirements and introduce Avoca Terrigal S.R.L. our EU-based partner for EU Authorised Representative services.

By Val Theisz

The EU Medical Devices Regulation or MDR and the In Vitro Diagnostic Medical Devices Regulation or IVDR introduced more stringent requirements for EU Authorised Representatives. These are outlined in Article 11 of the MDR and IVDR.

While in the past designation of EU Authorised Representatives could be done simply by issuing a letter by the non-EU manufacturers, the new regulations stipulate that the designation must be done via a “mandate” that is valid only when accepted in writing by the Authorised Representative.

The mandate must require, and the manufacturer must enable, the Authorised Representative to perform at least following tasks:

1. verify existence of EU declaration of conformity (DoC) and technical documentation and, where applicable, check appropriateness of the conformity assessment procedure carried out by the manufacturer;
2. keep available a copy of the technical documentation, the EU DoC and, if applicable, a copy of the relevant certificate, including any amendments and supplements at the disposal of competent authorities for the required period;
3. comply with the registration obligations regarding Single Registration Number (SRN) and verify manufacturer compliance with the registration obligations regarding Unique Device Identification System (UDI) and Eudamed;
4. respond to competent authorities’ requests with information and documentation necessary to demonstrate the conformity of a device;
5. forward to the manufacturer any request by a competent authority of the Member State in which the authorised representative has its registered place of business for samples, or access to a device;
6. cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;
7. inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;
8. terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.

The overseas manufacturers may delegate some but not all their obligations to their EU Authorised Representatives. The following manufacturer’s obligations may not be delegated to the EU Authorised Representative:

• ensure that medical devices have been designed and manufactured in accordance with the requirements of MDR/IVDR when placing them on the market or putting them into service;
• establish, document, implement and maintain a system for risk management as described in the MDR/IVDR;
• conduct a clinical evaluation in accordance with the requirements set out in the MDR/IVDR.
• draw up and keep up to date technical documentation for medical devices other than custom-made devices, to allow the conformity assessment of the device with the requirements of the MDR/IVDR;
• draw up a DoC and affix the CE marking of conformity to show compliance of medical devices, other than custom-made or investigational devices, with the applicable general safety and performance requirements (GSPR);
• comply with the obligations relating to the UDI system and with the Eudamed registration obligations;
• establish, document, implement, maintain, keep up to date and continually improve a quality management system for mass production and design change management in compliance with MDR/IVDR in a manner that is proportionate to the risk class and the type of device
• implement and keep up to date the post-market surveillance system in accordance with MDR/IVDR requirements;
• comply with the requirements for information supplied with the device in an official Union language(s) determined by the Member State in which the device is made available to the user or patient;
• take the necessary corrective action regarding non-conforming devices placed on the market or put into service, and inform the distributors of the device in question and, where applicable, the authorised representative and importers accordingly

Market Access (AUS) collaborates with EU-based Avoca Terrigal S.R.L. to provide EU Authorised Representative services to our MedTech start-ups (note the unmistakable Australian connection in the name!). Avoca Terrigal S.R.L. is registered in Eudamed under Actor ID/SRN RO-AR-000034301.

Market Access (AUS) and Avoca Terrigal S.R.L. are independent services providers, we are not involved in the sale or distribution of medical devices anywhere in the world, which ensures we are completely independent and free from conflicts of interest.

Manufacturers may change to another EU Authorised Representative if they so wish. The arrangement for a change of authorised representative must be detailed in an agreement between the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised representative.

The agreement must cover at a minimum the following aspects:

1. the date of termination of the mandate of the outgoing authorised representative and date of beginning of the mandate of the incoming authorised representative;
2. the date until which the outgoing authorised representative may be indicated in the information supplied by the manufacturer, including any promotional material;
3. the transfer of documents, including confidentiality aspects and property rights;
4. the obligation of the outgoing authorised representative after the end of the mandate to forward to the manufacturer or incoming authorised representative any complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device for which it had been designated as authorised representative.

Further information on EU Authorised Representatives, Importers and Distributors: European Commission Factsheet