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The Authorised Representative in the EU (AR, EC REP) plays an important role for medical device companies located outside the European Union and seek to sell their products within the EU territory.
The requirement for having an Authorised Representative is outlined in both European regulations: in the Medical Devices Regulation (MDR) and in the In Vitro Diagnostic Medical Devices Regulation (IVDR). Each of the regulations dedicates a separate article to the Authorised Representative, namely, Article 11.
One of the important requirements of European regulations is that there must be a written agreement between the manufacturer and the Authorised Representative, officially referred to as the Authorised Representative Mandate, which European supervisory authorities may request if necessary. The mandate has some characteristics that distinguish it from other contracts.
Below, we will discuss these characteristics and what should be included in the agreement with the Authorised Representative.
It makes sense to begin with who can serve as your Authorised Representative. In other words, what conditions must they meet. And these conditions should be reflected in the mandate.
In principle, there are two main conditions.
The next point that must be considered in the mandate of the Authorised Representative is his responsibilities.
Certain responsibilities of the Authorised Representative are defined by law and outlined in the MDR / IVDR. These can be directly taken from these regulations with little to no modification. These include requirements such as:
Another group of responsibilities of the Authorised Representative that can be included in the contract covers functions that are not stipulated by legislation as mandatory but can be present in the mandate if corresponding agreements are reached with the manufacturer.
These may include the following duties:
MDR and IVDR specify types of activities that should not be included in the agreement between the manufacturer and the Authorised Representative. These activities encompass aspects such as product design, specification creation, quality management system requirement development, and technical documentation compilation. The responsibility for these activities lies entirely with the manufacturer.
The Authorised Representative shares responsibility for the medical devices mentioned in the mandate, alongside the manufacturer. Therefore, the Authorised Representative must have continuous access to the manufacturer's up-to-date technical documentation, covering the entire lifecycle of each product. This right should be specified in the contract.
The same applies to changes in the manufacturer's quality system. Any significant changes that may directly impact the production or key processes, such as the collection and updating of clinical data, post-market surveillance, incident reporting, etc., must be communicated by the manufacturer to the Authorised Representative. It would be entirely reasonable for the Authorised Representative to want to see relevant provisions in the mandate.
In the case of any changes that may affect the safety, effectiveness, or quality of the medical devices, the manufacturer must promptly notify the Authorised Representative. Additionally, the Representative must be informed of any changes in the manufacturer's details, including changes in contact information.
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The Authorised Representative in the EU (AR, EC REP) plays a crucial role for medical device companies located outside the European Union and seek to sell their products within the EU territory.
The requirement for having an Authorised Representative is outlined in both European regulations: in the Medical Devices Regulation (MDR) and in the In Vitro Diagnostic Medical Devices Regulation (IVDR). Each of the regulations dedicates a separate article to the Authorised Representative, namely, Article 11.
One of the important requirements of European regulations is that there must be a written agreement between the manufacturer and the Authorised Representative, officially referred to as the Authorised Representative Mandate, which European supervisory authorities may request if necessary. The mandate has some characteristics that distinguish it from other contracts.
Below, we will discuss these characteristics and what should be included in the agreement with the Authorised Representative.
It makes sense to begin with who can serve as your Authorised Representative. In other words, what conditions must they meet. And these conditions should be reflected in the mandate.
In principle, there are two main conditions.
The next point that must be considered in the mandate of the Authorised Representative is his responsibilities.
Certain responsibilities of the Authorised Representative are defined by law and outlined in the MDR / IVDR. These can be directly taken from these regulations with little to no modification. These include requirements such as:
Another group of responsibilities of the Authorised Representative that can be included in the contract covers functions that are not stipulated by legislation as mandatory but can be present in the mandate if corresponding agreements are reached with the manufacturer.
These may include the following duties:
MDR and IVDR specify types of activities that should not be included in the agreement between the manufacturer and the Authorised Representative. These activities encompass aspects such as product design, specification creation, quality management system requirement development, and technical documentation compilation. The responsibility for these activities lies entirely with the manufacturer.
The Authorised Representative shares responsibility for the medical devices mentioned in the mandate, alongside the manufacturer. Therefore, the Authorised Representative must have continuous access to the manufacturer's up-to-date technical documentation, covering the entire lifecycle of each product. This right should be specified in the contract.
The same applies to changes in the manufacturer's quality system. Any significant changes that may directly impact the production or key processes, such as the collection and updating of clinical data, post-market surveillance, incident reporting, etc., must be communicated by the manufacturer to the Authorised Representative. It would be entirely reasonable for the Authorised Representative to want to see relevant provisions in the mandate.
In the case of any changes that may affect the safety, effectiveness, or quality of the medical devices, the manufacturer must promptly notify the Authorised Representative. Additionally, the Representative must be informed of any changes in the manufacturer's details, including changes in contact information.
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We do not use our own or third-party analytical, preferences, statistics, marketing, functional, advertisement, performance or any other non-essential cookies.