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.
Who Can Be an Authorised Representative in the EU
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 Authorised Representative must be a legal entity registered in one of the European Union countries, where they act as the point of contact with EU supervisory authorities - primarily in the country where they are located.
The representative must have a Person Responsible for Regulatory Compliance (PRRC). The Authorised Representative must have such a person on staff or have permanent access to an external PRRC. The PRRC, in turn, must have sufficient experience in the field of European regulatory requirements for medical devices or in vitro diagnostic products.
Duties of the Authorised Representative according to the AR agreement
The next point that must be considered in the mandate of the Authorised Representative is his responsibilities.
Mandatory provisions of the Authorised Representative's mandate
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:
Ensuring the availability and currency of the Declaration of Conformity and technical documentation.
Verifying that the conformity assessment procedure has been completed in full.
Retaining copies of the technical documentation and relevant certificates.
Fulfilling the obligation to register medical devices in the Eudamed system.
Collaborating with competent authorities.
Optional Provisions of the Mandate
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:
Product registration with national regulatory authorities (if needed).
Obtaining Certificates of Free Sale.
Certain functions related to post-market surveillance.
Incident reporting.
What should not be included in the Authorised Representative Agreement
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.
Rights of the Authorised Representative
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.
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.
Who Can Be an Authorised Representative in the EU
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 Authorised Representative must be a legal entity registered in one of the European Union countries, where they act as the point of contact with EU supervisory authorities - primarily in the country where they are located.
The representative must have a Person Responsible for Regulatory Compliance (PRRC). The Authorised Representative must have such a person on staff or have permanent access to an external PRRC. The PRRC, in turn, must have sufficient experience in the field of European regulatory requirements for medical devices or in vitro diagnostic products.
Duties of the Authorised Representative according to the AR agreement
The next point that must be considered in the mandate of the Authorised Representative is his responsibilities.
Mandatory provisions of the Authorised Representative's mandate
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:
Ensuring the availability and currency of the Declaration of Conformity and technical documentation.
Verifying that the conformity assessment procedure, as specified in the MDR or IVDR, has been completed in full.
Retaining copies of the technical documentation, Declaration of Conformity, and, for products requiring certification, relevant certificates.
Fulfilling the obligation to register medical devices in the Eudamed system.
Providing supervisory authorities, upon request, with all necessary information and documentation to demonstrate product compliance with regulatory requirements.
Furnishing the manufacturer with any requests from EU supervisory authorities.
Collaborating with competent authorities regarding preventative or corrective actions (CAPA).
Promptly notifying the manufacturer of reports from healthcare professionals, patients, and users regarding presumed incidents.
Optional Provisions of the Mandate
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:
Product Registration with National Regulatory Authorities. In some cases, products need to be registered with the regulatory authorities of an EU member state. This function is often taken on by the Authorised Representative.
Certificates of Free Sale. Such certificates are issued by the regulatory authorities of EU countries. They are frequently required for product registration in Asian and Latin American countries. If you plan to enter these markets, it makes sense to include a provision in the contract for the Authorised Representative to obtain such certificates.
Post-Market (Post-Registration) Surveillance. By agreement, the Authorised Representative may take on certain functions related to post-market surveillance. In this case, it is advisable to specify in the mandate which specific functions the representative will perform.
Incident Reporting. By agreement with the manufacturer, the Authorised Representative may undertake certain functions related to incident reporting and processing incidents to the regulatory authorities of the European Union.
What should not be included in the Authorised Representative Agreement
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.
Rights of the Authorised Representative
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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