The responsibilities of an EU Authorized Representative are defined in the European legislation, but it is essential to clearly stipulate the tasks your Authorized Representative will assume on your behalf.
Duties and responsibilities result from the defined role of an Authorized Representative
Under the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR),
“‘authorized representative’ means 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 […]”.MDR, IVDR
mdi Europa will be your European Regulatory Affairs representation. As such, we will be responsible towards the EU competent authorities that you, the manufacturer, fulfill all duties and responsibilities as stipulated by the Regulations.
The EU authorities will not correspond with non-European manufacturers directly. All contacts and correspondence with regards to your company and your devices will go via your European Regulatory Affairs Representative, mdi Europa.
The name and address of your European Authorized Representative must be shown on your labeling, packaging or instructions for use. As a result, various parties from all over Europe will contact us, when they have queries or questions regarding your devices. This means, we will be in constant communication with your distributors, end-users, customers, etc.
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mdi Europa will support all necessary reporting, registration and communication with European authorities and bodies – to the right person at the right time, every time. The Regulations also require that the European Authorized Representative holds a copy of the manufacturers Declaration of Conformity and Technical File and a register of product complaints in Europe.
The points above must be clearly defined in a formal mandate. Manufacturers should also be aware that under the MDR and IVDR the EU Authorized Representative becomes fully liable for the manufacturer’s devices.
What you get on top
mdi Europa may assume a range of additional services – please get in touch with us to find out more about us and our portfolio.
Independently owned and operated, mdi Europa ensures the elimination of every possible conflict of interest with regards to confidential trade or product information. We guarantee the highest level of professional confidence and courtesy at all times. This is confirmed in our standard service contract, or – at your request – by signing a separate confidentiality agreement with you.