EU Authorized Representative Responsibilities

authorized representative” means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter’s obligations under this Directive.

This is how the European medical device Directives define the duties and responsibilities of an Authorized Representative. Obviously, the text of the Directives serves as the basis for our daily work. But we do more:

We 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 Directives.

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.

mdi Europa will take care of all necessary reporting, registration and communication with European authorities and bodies – to the right person at the right time, every time. The Directive also requires that the European Authorized Representative holds a copy of the manufacturers Technical File and a register of product complaints in Europe.

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.

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