MDCG issued its first 2021 guidance that clarifies to Member States and other parties on the application of certain MDR provisions during the absence of EUDAMED. The guidance describes harmonised administrative practices and alternative technical solutions for the exchange of information until EUDAMED becomes fully functional. Many important aspects have been clarified, such as:
- Alternative solutions to submit and/or exchange information for Registration of devices (as per art. 29 of the MDR), should be carried out by the manufacturer, based on the following instructions:
- As soon as the functionality is available in Eudamed, the system may be used for registration of devices even before the notice of full functionality of Eudamed has been published. Nevertheless, manufacturers should refer to the national provisions in Member States establishing product registration schemes. Manufacturers should note that the obligation of UDI assignment (Basic UDI and UDI-DI) to a device applies from 26 May 2021 (Art. 27(3) MDR). Labelling requirements apply gradually, starting from 26 May 2021 (Art. 123(3)(f) MDR)
- Alternative solutions to submit and/or exchange information for Summary of safety and clinical performance (as per art. 32 of the MDR), should be carried out by the manufacturer and Notified Body, based on the following instructions:
- The SSCP shall be made available to the public upon request without undue delay or the manufacturer shall specify where it is made available to the public. As soon as the functionality is available in Eudamed, the system may be used for the upload of the SSCP even before the notice of full functionality of Eudamed has been published.
- Alternative solutions to submit and/or exchange information for Involvement of notified bodies in conformity assessment procedures, in conj. with Section 4.3 of Annex VII (as per art. 53 of the MDR), should be carried out by the Commission (via CircaBC, template) and Notified Bodies (via data upload), based on the following instructions:
- Notified bodies should upload the required information to a dedicated secure directory in CircaBC, using a pre-defined template as soon as it becomes available (organised by the Commission). The required information may also be made available via a national system, provided that compliance with requirements on notification of all other notified bodies is ensured.
- Alternative solutions to submit and/or exchange information for Clinical evaluation consultation procedure for certain class III and class IIb devices (as per art. 54 of the MDR), should be carried out by the Commission (via CircaBC, template, expert panel platform) and Notified Bodies (via data upload), based on the following instructions:
- Notified bodies should notify the relevant parties by uploading the required information to a dedicated secure directory in CircaBC, using a pre-defined template as soon as it becomes available (organised by the Commission). The Commission will provide and manage a technical platform related to the functioning of expert panels. Guidance on this technical solution will be provided separately to relevant parties.
- Alternative solutions to submit and/or exchange information for Certificates of conformity (as per art. 56 of the MDR), should be carried out by Notified Bodies, based on the following instructions:
- 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.
- Alternative solutions to submit and/or exchange information for Application for clinical investigations (as per art. 70 of the MDR), should be carried out by Sponsors (via application) and Commission (via publication), based on the following instructions:
- The application for clinical investigations should take place via the respective national procedures applicable to clinical investigations. Non-substantial modifications will be notified to the Member State before its implementation, via respective national procedures, unless otherwise defined by the Member State. The notification of the relevant information should take place via the respective national procedures applicable to clinical investigations. A list of national contact points for submission should be published on the Commission website. The new clinical investigation application form developed under the MDR framework may be considered at national level to the extent possible.
- Alternative solutions to submit and/or exchange information for Corrective measures to be taken by Member States and information exchange between Member States (as per art. 76 of the MDR), should be carried out by Member States (CircaBC) based on the following instructions:
- The communication of the relevant information to other Member States and to the Commission should take place by uploading the required information to a dedicated secure directory in CircaBC, using a pre-defined template once available.
- Alternative solutions to submit and/or exchange information for recording and reporting of adverse events that occur during clinical investigations (as per art. 80 of the MDR), should be carried out by Sponsors (via notification) based on the following instructions:
- The reporting should take place via the respective national procedures applicable to clinical investigations and in accordance with the MDCG Guidance on safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745.
In addition, it is highlighted that the Commission and other relevant parties should endeavour to make use of already existing CircaBC directories to the extent that this is possible.
Go to our Library of documents – MDCG to have a look at this important Guidance and all other relevant MDCG documents.
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