The Medical Device Coordination Group (MDCG), an advisory body of the European Commission comprised of the representatives of all Member States, has published a guidance document dedicated to harmonized administrative practices and alternative technical solutions until EUDAMED is fully functional. The guidance provides an overview of the alternatives that could be applied before EUDAMED, the new union-wide database for medical devices, would be fully functional. At the same time, it is also important to mention that the present document does not have legal force and only provides certain recommendations to be considered by the parties involved in operations with medical devices placed on the EU market.
Regulatory Background
The union-wide database of medical devices should be introduced in accordance with Article 33 of the Medical Devices Regulation 2017/745 (MDR), the new regulation on medical devices replacing the Directives. The regulation prescribes that the new database should be comprised of six modules covering the following aspects:
- Registration of entities, medical devices, systems, and procedure packs;
- Registration of notified bodies and certificates;
- Conformity assessment;
- Clinical investigations;
- Vigilance;
- Market and post-market surveillance.
According to the notice published by the European Commission later in October 2019, the new database requires all six modules operating to be ready for launch. The initial launch of EUDAMED was scheduled for May 2022, which is the date when the new In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 enters into force. At the same time, in accordance with the applicable provisions of the new Regulations, should the new database be not available and fully functional before the MDR enters into force, the appropriate provisions of the previous Directives should be applied with regard to the requirements on the information exchange.
The scope of the present MDCG guidance describes the alternative approaches to be applied during the period when the new database is unavailable. In particular, the document describes procedures and processes to be applied with regard to the information exchange before all modules of EUDAMED would become available and operating. The suggested approach describes the most efficient way the parties involved may achieve and sustain compliance with the regulatory requirements set forth under the MDR. The approach suggested in the document is also based on the decision to make each module of the new database available for use as soon as it becomes operational. The appropriate decisions were taken earlier in March 2020, to accelerate the availability of the new union-wide database on medical devices. However, the approach outlined in the document should not contradict the procedures prescribed by the MDR. Moreover, as soon as EUDAMED would become fully operational, all the parties involved should achieve and sustain compliance with any and all information exchange requirements set forth therein.
The document also refers to the MDCG guidance on the EUDAMED actor registration module.
EUDAMED Alternative Solutions
The present MDCG guidance describes in detail the alternative solutions to be applied by all the parties involved in operations with medical devices in order to comply with the regulatory requirements on information exchange set forth by the new Regulations. For this purpose, the document contains a schedule indicating the appropriate article of the MDR, its brief description, a description of an alternative approach to be applied, and also the parties responsible for implementation. The alternative solutions suggested by the MDCG include, inter alia, the following ones:
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- As soon as the functionality is available in Eudamed, the system may be used for the registration of devices even before the notice of full functionality of Eudamed has been published. Nevertheless, manufacturers should refer to the national provisions in the Member States establishing product registration schemes.
- The same approach as described above could be applied with regard to the registration of manufacturers, authorized representatives, and importers.
- The submission of the different sets of the required information will become possible on a voluntary basis from the date when the Commission makes available the respective Eudamed module.
- The publication of notifications continues to take place via NANDO.
- The information in relation to requests for suspension or withdrawal of certificates is managed at a national level. The obligation to inform the competent authority for medical devices of the Member States in which the manufacturer has its registered place of business should take place by suitable communication channels (e.g. secure directory in CircaBC or e-mail).
As explained in the document, CircaBC stands for the Communication and Information Resources Centre for Administration, Business, and Citizens, where the dedicated secure directories could be created. According to the document, the notified bodies should upload the information on medical devices to the appropriate directories in CircaBC once it becomes available. However, the appropriate national systems could still be applied. In such a case, it is also important to ensure compliance with the notification requirements prescribing that all other notified bodies should be informed properly.
The technical platform supporting the activity of the expert panels would be managed by the European Commission.
Another important aspect relates to the operations with the certificates. According to the present MDCG guidance, certificates will be made available upon request or will be uploaded in the national system where required. As soon as the functionality is available in Eudamed, the system may be used for the upload of the certificates even before the notice of full functionality of Eudamed has been published.
Additional Aspects of Information Exchange
Besides the points highlighted hereabove, the present MDCG guidance covers various aspects of the information exchange procedures to be applied by the parties involved in operations with medical devices in accordance with the current regulatory requirements. For instance, the document states that in case of applications for clinical investigations the national procedures could be applied. The same approach should be used in case of non-substantial modifications thereto.
The document also mentions the CIV-ID – a new union-wide unique single identification number for clinical investigations used to identify the information related to the particular clinical investigation.
Summarizing the information provided here above, the present MDCG guidance describes the approach to be applied by all the parties involved in operations with medical devices in order to achieve and sustain compliance with the regulatory requirements on information exchange set forth by the MDR before EUDAMED will be fully operational and available for use. In this regard, the document describes the particular processes and procedures to be applied. According to the document, the information exchange procedures set forth under the national legislation could be applied before the new database for medical devices will become operational. Moreover, according to the decision taken, the implementation of EUDAMED should take place gradually – the modules should be launched and accessible one by one as soon as they become available. At the same time, the approach suggested in the document should not replace the regulatory requirements set forth under MDR. The procedures described therein would remain applicable only during the period of time the new database is under development.
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