EUDAMED, the European database intended to gather all relevant information on Medical Devices should be officially launched in May 2022 (with one year delay). Only one functionality is operational since December 2020, the registration module (module 1) of the actors and of the single registration number (SRN).
The new guidance, issued by the Medical Device Coordination Group in February 2021, is intended to describe harmonized practices and alternative technical solutions for the exchange of information until EUDAMED becomes fully functional.
Different items of MDR2017/745 are concerned by this document.
For article 29 (Registration of devices) or article 31 (Registration of manufacturers, authorized representatives, and importers), the system may be used as soon as the functionality is available in Eudamed even before the notice of its full functionality has been published. It has noted that the module 1 for manufacturers and packers is already operational. The same applies for uploading the SSCP (Article 32: Summary of safety and clinical performance)
For clinical investigations including those for devices bearing the CE marking (chapter VI: clinical evaluations and clinical investigations), respective national procedures remain applicable until availability of the relevant Eudamed module. This also applies for the recording and reporting of adverse events during clinical investigations (article 80) that shall also be conducted in accordance with the MDCG 2020-10/1 and 2020-10/2. The new clinical investigation application form developed under the MDR framework may be considered at national level to the extent possible. Regarding article 73 (Electronic system on clinical investigations), Eudamed2 platform will be still used by member states for issuing a Union-wide unique single identification number (the ‘CIV-ID’) for clinical investigations. This is the continuation of current MDD practice. Because MDR is requiring that the summary and the clinical investigation report shall become publicly accessible through EUDAMED before it is placed on the market, in the transition period, these data should be shared and published via the use of a dedicated publicly available CircaBC directory (article 77). Very interestingly, the procedure for coordinated assessment (article 78) will become mandatory only as of 27 May 2027. No harmonization can be expected sooner as prior to that, the application of the procedure is voluntary.
In this guidance, there are also provisions related to chapter VII (Post market surveillance, vigilance, and market surveillance). Thus, with regards to article 86 related to PSUR, manufacturers of class III devices, classes IIa, and IIb implantable devices, should deliver the PSURs to their notified body by appropriate means such as pdf sent by email. For serious incidents, FSCA and FSN, manufacturers shall pursue reporting according to their respective/relevant national vigilance systems. For serious incidents, the MIR form in place since January 2020 already integrating MDR requirements shall be used (article 87 & 89). For FSCA, the current form is still valid (additional information required under the MDR may be added to the general comments section of the form). For FSN, the competent authorities should make them publicly available to the public in accordance with their national legislation. Regarding the Trend Report, the current form should be used until its updating for MDR compliance (article 88).
For MDR device, communication between competent authorities should take place through a dedicated secure directory in CircaBC (organised by the Commission).
For Legacy and older devices, the existing Eudamed2 system for the NCAR should continue to apply. The coordinating competent authority shall inform by email or other suitable communication channels.
For market surveillance, member States might make available the summaries of this surveillance to the public on their websites.
With regards to article 120 related to transitional provisions, it is important to highlight that these alternative technical solutions set out in this MDCG guidance should also apply to legacy devices where appropriate, considering the availability of the respective EUDAMED modules.
As a conclusion, in addition to the EUDAMED procedure, it is recommended to ensure that all your relevant procedures integrate these alternatives before May 26, 2021, if it is not already done.