The new article provides additional details regarding the aspects related to the responsibilities of authorized representatives.
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission (EC) responsible for medical devices regulations, has published a guidance document dedicated to authorized representatives to be appointed by medical device manufacturers based in non-EU countries to be allowed to offer their products in the EU Member States. In particular, the document provides additional clarifications regarding the applicable regulatory requirements set forth under the Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic Medical devices Regulation 2017/746 (IVDR) – collectively “the Regulations” – as well as recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance thereto. At the same time, provisions of the guidance are non-binding and are not intended to introduce new rules or impose new obligations. It is explicitly stated that the present guidance document is not an official EC document, while in case of any discrepancies with the provisions of the applicable regulations the latter should prevail.
The document describes, inter alia, the key points related to the mandate as an authorizing document to be issued by a foreign medical device manufacturer, empowering its authorized representative to act on behalf of the manufacturer and perform its functions as it is set forth under the Regulations. In particular, the Regulations explicitly state that the mandate cannot be used to delegate certain obligations of the manufacturer under the MDR/IVDR, even though the authorized representative may assist the manufacturer in performing the respective functions.
Furthermore, it is also stated that importers should verify that the authorized representative following Article 11 has been designated by the manufacturer. The corresponding requirement is set forth by both MDR and IVDR. For this purpose, importers may check the name of an authorized representative that should appear on documentation related to the product, e.g., the EU declaration of conformity or labeling. The validity of the designation could also be checked via the EUDAMED, the EU-wide database for medical devices, or by contacting the manufacturer directly to obtain the respective confirmation. The said confirmation could be provided in the form of a letter of designation or its copy.
Registration & Verification Obligations
The document further describes in detail the obligations of authorized representatives related to registration and verification. In this respect, the MDCG distinguishes the authorized representatives’ obligations, and also the ones they have towards medical device manufacturers.
According to the Regulations, authorized representatives are required to ensure compliance with the registration obligations set forth therein. This includes, inter alia, submitting their details for inclusion in the database. Apart from this, an authorized representative is obliged to ensure that:
- Its registered information is updated within one week of any change occurring; and
- The accuracy of the data has been submitted at intervals defined in Article 31(5) MDR/Article 28(5) IVDR, namely not later than one year after the initial submission of the information, and every second year thereafter.
Concerning the information related to authorized representatives to be included in the EUDAMED, the MDCG refers to the respective guidance document “EUDAMED: Economic Operator user guide” which describes in detail the procedures related to the mandate and the way it should be reflected in the database.
Apart from the ones described hereinabove, the Regulations also establish the obligations of authorized representatives toward medical device manufacturers. For instance, authorized representatives should verify whether the manufacturer follows the requirements related to the UDI and device registration. The MDCG additionally emphasizes that in line with Article 11(4) of the Regulations, the manufacturer’s obligation to register its information and devices in EUDAMED cannot be delegated to the authorized representative.
Minimum Tasks and Responsibilities
The document also deals with the minimum tasks and responsibilities of authorized representatives as set forth under the Regulations. In this respect, it is stated that the medical device manufacturer should take all the steps necessary to enable the representative it has authorized to conduct the tasks covered by the scope of a mandate.
As required under the Regulations, an authorized representative should verify that the EU declaration of conformity and technical documentation has been drawn up (i.e. check the existence of such documents) and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer; while if the authorized representative considers or has reason to believe that the conformity assessment procedure is not appropriate for the device in question, they may inform the manufacturer.
Apart from merely checking the existence of key documents related to medical devices, an authorized representative is also in charge of keeping a copy of the technical documentation. The said documentation should be duly kept within the timeframes set forth under the Regulations – at least 10 years (15 years for implantable products) from the date the last product in question has been placed on the market. At the same time, there is a corresponding obligation of the medical device manufacturer to ensure that the authorized representative is provided with all the technical documentation it should have access to. The Regulations employ the concept of “Permanent availability”, which stands for an obligation of the manufacturer to provide the most recent versions of documentation and certificates. The said documents should be constantly available in paper or electronic format.
In summary, the present MDCG guidance describes in detail the responsibilities of authorized representatives and provides classification thereof based on the dependence on the manufacturer. The document also explains how the obligations of medical device manufacturers and their authorized representatives correspond to each other.
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