MDR and IVDR Services - The MDSS Solution!

MDSS has been working to provide all our clients with the most suitable options for all manufacturers to be in compliance with the European Union Medical Device Regulation (MDR (EU) 2017/745) and In-Vitro Device Regulation (IVDR (EU) 2017/746).

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MDR (EU) 2017/745 / IVDR (EU) 2017/746

Article 11

1. Where the 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.

2. The designation shall constitute the authorised representative’s mandate, it shall be valid only when accepted writing by the authorised representative and shall be effective at least for all devices of the same generic device group.

Establish Mandate with MDSS contact.

3. The authorized representative shall perform the tasks specified in the mandate agreed between it and the manufacturer. The authorised representative shall provide a copy of the mandate to the competent authority, upon request.

Tasks are outlined in the contract mandated.

4. The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks in relation to the devices that it covers.

Tasks and responsibilities are stipulated in the MDSS contract. 

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MDR (EU) 2017/745 / IVDR (EU) 2017/746

- For Manufacturers who have a subsidiary in the European Union

- For Manufacturers who want to set up a subsidiary in the European Union

Supported by MDSS Consulting GmbH - Your partner for your best solution!