The article provides an overview of the clarifications provided concerning solutions available during the temporary unavailability of the global European database.
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The Medical Device Coordination Group (MDCG), an advisory body of the European Commission (EC), has published a guidance document describing harmonized administrative practices and alternative technical solutions until Eudamed, the new union-wide database for medical devices will be fully functional concerning in vitro diagnostic (IVD) medical devices covered by the scope of Regulation 2017/746 (IVDR). The document is intended to provide recommendations to be followed by medical device manufacturers and other parties involved in operations with medical devices placed on the market and used in the European Union. At the same time, it is important to mention that the present guidance does not constitute an official EC document and is non-binding.
Regulatory Background
According to the existing legal framework, the new EU-wide database on medical devices, Eudamed, should include 6 electronic systems (modules) intended to improve and streamline the processing of regulatory information related to medical devices, generated in the course of various activities by all the parties involved, including medical device manufacturers, notified bodies and certification agencies. The new database is intended to contain information about medical devices themselves, as well as certificates issued, clinical investigations in which the devices are used, various performance studies, and also activities related to post-market surveillance.
At the same time, current legislation also provides that the new database would not be fully operational for a certain period, hence, a transitional period will apply. Thus, the present guidance is intended to provide additional clarifications regarding the way the Eudamed-related provisions of the new regulations on general and in vitro diagnostic devices (MDR and IVDR) should be applied during the period when the new database is not fully operational. In particular, the document describes harmonized administrative practices and alternative technical solutions for the exchange of information until Eudamed becomes fully functional. The approach described in the guidance is expected to assist medical device manufacturers and other parties involved in complying with the regulatory requirements they are subject to according to the new Regulations. For instance, the scope of the guidance covers, inter alia, the aspects related to information exchange and steps to be taken to ensure its efficiency. At the same time, the MDCG additionally emphasizes that the recommendations provided herein should not impact the obligations of the parties as set forth by the regulations. The guidance also refers to the MDCG documents dedicated to the Eudamed actor registration module and the Single Registration Number (SRN).
The document describes the articles of the Regulations dedicated to the regulatory procedures requiring integration with Eudamed and provides recommendations to be followed to address the issues associated thereto. As it was mentioned before, the scope of the present guidance covers only in vitro diagnostic medical devices.
Registration of Medical Devices
According to Article 26, IVDR, when registering an IVD product, it is necessary to assign a Basic UDI-DI and provide it to the respective database. It is further stated that after the issuing of the relevant certificate and before placing the device on the market, the manufacturer shall provide the Basic UDI-DI to the UDI database; and also the manufacturer shall enter or, if already provided, verify in Eudamed the information referred to in Section 2 of Part A of Annex VI.
Concerning the above, the authority mentions that the functionality which is necessary to perform the above actions is already available in the new database. Moreover, the system could already be used voluntarily, even if the database is not fully functional yet. However, the parties applying for medical device registration are allowed to follow the regulatory requirements for product registration as set forth by the respective national legislation. The authority also mentions that the actual implementation of some of the requirements is subject to transitional rules – for instance, the requirements related to labeling for in vitro diagnostic medical devices will become applicable starting from May 26, 2023.
Establishment Registration
The guidance also provides clarifications regarding the applicability of the provisions related to the registration of manufacturers, authorized representatives, and importers. By the respective article of the Regulation, an applicant entity is required to obtain a single registration number (SRN), and then use it for reference purposes in all interactions with a notified body, and also for accessing the new database.
According to the guidance, the above functionality is already available in Eudamed as well and could be used voluntarily for the registration of the parties involved in operations with medical devices. In this respect, the guidance refers to the MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States.
Safety and Performance-Related Data
As set forth by the IVDR, the parties responsible for Class C and D medical devices – the ones associated with a relatively high risk – are obliged to provide a summary of safety and performance concerning the products intended to be marketed and used in the EU. According to the IVDR, the said information shall be made available to the public via Eudamed. Moreover, the respective documentation should be subject to validation by the notified body, and once the information is validated, a summary should be uploaded to the database.
According to the guidance, the functionality related to the SSP shall be available upon request, even if the database, in general, is not fully operational.
In summary, the present MDCG guidance explains the approach to be applied to comply with certain requirements set forth by the IVDR during the period when Eudamed is not fully operational. The document highlights the key points to be taken into consideration and provides recommendations to be followed by medical device manufacturers and other parties involved.
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