Jul 21, 2022

The European Commission’s Medical Device Coordination Group (MDCG) published new resolutions to help in vitro diagnostic (IVD) device manufacturers comply with the In Vitro Diagnostic Medical Devices Regulation (IVDR) in the interim until the full rollout of the Eudamed database is complete. The guidance, MDCG 2022-12 - Harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for IVDR), offers practical compliance workarounds for manufacturers. The Eudamed medical device and IVD product database is being launched to improve European market transparency so the public can check the safety of medical devices and IVDs.

How can manufacturers comply with IVDR prior to a fully functional Eudamed database?

According to the latest update to the timeline on the Eudamed page, the database is slated to have all six modules in operation and achieve full functionality in mid-2024. Until then, Economic Operators—manufacturers, EU Authorized Representatives, importers, distributors and Notified Bodies—may voluntarily enter data into the modules currently available. The three available modules are Actor Registration; UDI/Device Registration; and Notified Bodies and Certificates.

Three additional modules—Clinical investigations and Performance Studies; Vigilance and Post-market Surveillance; and Market Surveillance—are scheduled to launch in late 2023, but Eudamed will not be considered fully functional until the completion of an independent audit.

The new MDCG document addresses the IVDR compliance options manufacturers have in the interim. The proposed practices enable manufacturers to comply with the data requirements of certain provisions, such as Directive 98/79/EC of the IVDR, through alternative methods.

Alternate data submission options for manufacturers

Emergo by UL has focused the stated MDCG guidance into the six sections that are of particular interest to manufacturers along with alternative compliance methods:

Article 26 Registration of devices

Before placing a device on the market, manufacturers shall, in accordance with the rules of the issuing entity referred to in Article 24(2), assign a Basic UDI-DI as defined in Part C of Annex VI to the device and shall provide it to the UDI database together with other core data elements referred to in Part B of Annex VI related to that device.

Alternative practice: Manufacturers can comply with device registration, assignment and labeling requirements of the IVDRR by using the available modules in Eudamed for device registration. Manufacturers should also refer to the national provisions in EU member states establishing product registration schemes. Manufacturers are obligated to make a UDI assignment (Basic UDI and UDI-DI) to a device as of May 26, 2022 (Art. 24(3) IVDR). Labeling requirements will apply gradually, starting May 26, 2023, according to timelines set in Art. 113(3)(e) IVDR.

Article 29  Summary of safety and performance

For class C and D devices, other than devices for performance studies, the manufacturer shall create a summary of safety and performance. The summary of safety and performance (SSP) should be clearly understandable to intended users and, if relevant, patients and shall be made available to the public via Eudamed. The draft shall be part of the documentation submitted to the notified body involved in the conformity assessment pursuant to Article 48. The manufacturer shall mention on the label or instructions where to find the summary. The summary should include the identification of the device and the manufacturer, including the Basic UDI-DI and the SRN if already issued.

Alternative practice: The SSP shall be made available to the public upon request or specify where it is available. The functionality is present in Eudamed to upload the SSP.

Manufacturers may use the existing Actor Registration module but should refer 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.

Article 81 Periodic safety update report (PSUR)

Manufacturers of class D devices shall submit a PSUR by means of an electronic system referred to in Article 87 to the notified body involved in the conformity assessment of the device in accordance with Article 48.

Alternative practice: For class D devices, manufacturers should deliver the PSURs to the relevant notified bodies by appropriate means, such as secure email.

Article 82 Reporting serious incidents and field safety corrective actions

Manufacturers should report serious incidents and field safety corrective actions to the relevant national vigilance systems.

Alternative practice: The new Manufacturer Incident Reporting (MIR) form has already been adapted to IVDR requirements and should be used accordingly. The current Field Safety Corrective Action (FSCA) form should be used (any additional information required under the IVDR may be added to the general comments section of the form).

Article 83 Trend reporting

Manufacturers should report any statistically significant increase in the frequency or severity of incidents that are not serious or that have expected undesirable side effects that could have a significant impact on the benefit/risk analysis which have led to unacceptable risks to the health and safety of patients.

Alternative practice: Manufacturers must submit trend reports to the relevant national vigilance system. Use the current trend report form until it’s updated for the IVDR.

Article 84 Analysis of serious incidents and field safety corrective actions

Manufacturers should provide a final report to the competent authority setting out its findings from the investigation by means of an electronic system. The report should set out conclusions and take any relevant corrective action.

Alternative practice: Manufacturers shall enter the field safety notice in the electronic system, which must be publicly accessible. Communication with other competent authorities should take place through a dedicated secure directory in CircaBC (organized by the European Commission) for IVDR devices. For legacy and older devices, the existing Eudamed2 system for the National Competent Authority Report (NCAR) should continue to apply.

Emergo by UL will continue to post updates to Eudamed guidance as they are released.

Additional Eudamed and EU medical device regulatory resources from Emergo by UL:

Author

  • Kathryn Burke's picture
    Kathryn Burke

Related