The new article describes in detail the aspects related to the responsibilities of authorized representatives as set forth under the existing framework, as well as the liability they could be subject to, and situations when they are allowed to initiate termination of the mandate.
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission (EC) responsible for medical devices, has published a guidance document dedicated to the regulatory requirements for authorized representatives to be appointed by medical device manufacturers based in third countries to be allowed to market their products in the EU. The document provides additional clarifications regarding the requirements as per the existing regulatory framework based on the Medical Device Regulation (MDR) 2017/745 and the In Vitro Medical Devices Regulation (IVDR) 2017/746, as well as recommendations to be considered by all the parties involved to ensure compliance thereto. At the same time, the present guidance should not be construed as an official EC document since it is non-binding and could be subject to changes, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations.
Responsibilities of Authorized Representatives
The scope of the guidance covers, inter alia, the aspects related to the responsibilities of authorized representatives (ARs). In this respect, the MDCG highlights the following key points:
- According to Article 11(3)(d), in response to a request from a competent authority, the authorized representative must provide the competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned.
- To be able to comply with the above requirement, the authorized representative should also continuously stay in touch with the manufacturer, making sure that all necessary documentation is duly prepared by the latter and is available to the authorized representative. It is explicitly stated that the authorized representative should be able to demonstrate compliance with this obligation.
- According to Article 11(3)(e), authorized representatives are also obliged to forward to the manufacturer any request by a competent authority of the Member State in which the authorized representative has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device.
- As prescribed by Article 11(3)(f), the authorized representative should cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices.
- Apart from being in touch with the medical device manufacturer and the competent authority, the authorized representative should also maintain efficient communication with all the parties involved in processes related to the supply of medical devices, including importers and distributors.
- Article 11(3)(g) states that authorized representatives should immediately inform the manufacturer about complaints and reports from healthcare professionals, patients, and users about suspected incidents related to a device for which they have been designated.
Apart from responsibilities, the guidance describes the matters related to liability that authorized representatives could be subject to. In particular, Article 11(5) of the Regulations establishes the liability of authorized representatives for defective devices placed on the market, jointly and severally with the manufacturer. It is important to mention that the said liability applies even in case the non-compliance results from the actions or omissions of the medical device manufacturer. This places authorized representatives in a position where they have a particular interest to verify the compliance of medical device manufacturers with the requirements they are subject to. In certain cases, a competent court will decide whether there is a relationship between the failure of a manufacturer to comply with the respective requirements and the damage caused by the product in question, and this decision with impact of the authorized manufacturer being found liable jointly and severally.
It is also stated that authorized representatives should have the same rights to defend themselves as the manufacturer has under the respective legal framework.
As it was mentioned before, the authorization of an AR is based on the respective mandate issued by the medical device manufacturer. By Article 11(3)(h) of the Regulations, the mandate should enable the authorized representative to terminate the mandate if the manufacturer acts contrary to its obligations under the Regulations. Hence, an authorized representative is entitled to terminate its mandate, should the manufacturer fail to comply with the respective regulatory requirements. The MDCG further explains that due to the scope of applicability of the mandate, it could be terminated within the whole generic device group rather than a specific medical device.
Once the mandate is terminated by an authorized representative, the latter should immediately notify the regulating authority, as well as the notified body involved in the assessment of the product in question. Furthermore, should the said termination be related to a failure or refusal of the manufacturer to take the actions necessary to restore compliance with the applicable requirements, this should be also communicated to the regulating authority.
It is also important to mention that in certain cases, an authorized representative should continue supporting the products supplied during the period of designation in terms of cooperating with the authorities. This could be necessary in case there is no other authorized representative designated.
In summary, the present guidance covers certain specific aspects related to the activities undertaken by authorized representatives, their functions, and their responsibilities. The document outlines the situations in which an authorized representative could be found liable for non-compliance with the existing regulatory requirements, and also describes the way the mandate could be terminated by an authorized representative, should the medical device manufacturer fail to fulfill its obligations and sustain compliance with the respective requirements.
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