According to the Article 11(5) of the Regulations the authorised representative is legally liable for defective devices under the following terms: “Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10, the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.
In light of the above, the authorised representative may have a particular interest to verify that the manufacturer has fulfilled its obligations, including the manufacturer’s obligation to have measures in place to provide sufficient financial coverage (e.g. liability insurance) under Article 10(16) of the Regulations.
Therefore, we strongly suggest you will obtain a professional Product Liability policy with sufficient financial coverage applicable to your market.
Article 11(3) of the Regulations requires the authorised representative to perform the tasks specified in the mandate agreed between the authorised representative and the manufacturer. Upon request, the authorised representative has to provide a copy of the mandate to the competent authority. Article 11(3) of the Regulations describes the minimum tasks that the mandate (in relation to the devices that it covers) should comprise and which the manufacturer should enable the authorised representative to perform. The mandate may however also contain additional agreed tasks between the parties.
The Authorised Representative will:
Act as your official correspondent towards all National Competent Authorities.
Verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.
Comply with the registration obligation obligations laid down in Article 31 and verify that the manufacturer complies with the registration obligations laid down in Articles 27 and 29.
Communicate requests from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned.
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.
Immediately 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.
Submit Notification for your class I medical devices.
Where required by national regulation, Register your medical devices with the National Competent Authorities.
Medical Device and in vitro diagnostic medical devices labelling such as Instructions for Use, Device Label, Device Packaging, will include the Authorised Representative name and address. , the label or outer packaging or instructions for use shall contain the name and the address of the authorized representative where the manufacturer does not have a registered place of business in the Community.
Where a manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative (Article 11(1) MDR and IVDR).
As regards its portfolio of devices therefore, a manufacturer can have more than one authorised representative if the devices fall under different generic device groups (as defined in Article 2(7) MDR and Article 2(8) IVDR.3). However, for one specific generic device group, the manufacturer should designate only one authorised representative (i.e. a ‘sole’ authorised representative’).
Article 11(2) of the Regulations provide that ‘the designation shall constitute the authorised representative's mandate, it shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group’.
The manufacturer and the authorised representative are free to configure the structure of their contractual relationship as they see appropriate, as long as there is a written mandate that meets the minimum requirements of Article 11(3) of the Regulations and the content of which is agreed between the parties. A mandate should be drawn up irrespective of whether the authorised representative is independent/outside of, or is part of the same larger organization as the manufacturer.
An Authorised Representative is any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under this regulation (Article 2(32) MDR and Article 2(25) IVDR).
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