The MDCG Post Market Surveillance and Vigilance (PMSV) working group published minutes from their Oct 2024 meeting. They are available: HERE

The minutes include updates on pending Forms and Guidance, as well as development of the EUDAMED vigilance module.

Report Forms

Manufacturer Incident Report (MIR)

The Commission intends to publish the new MIR 7.3.1 (PDF file) in January 2025. It will be published under the Regulation section of the Commission website.

Field Safety Corrective Action (FSCA)

Due to the high level of complexity of the FSCA process, the form updates are limited to the main changes introduced by the Regulations. The revised form is intended for temporary use, until the fully compliant version is available in EUDAMED.

Regarding timing:

“…the updated FSCA form was already endorsed by the MDCG. Netherlands presented a further updated FSCA PDF document with only some editorial changes.”

Manufacturer Trend Report (MTR)

The MTR form will be released as a Word document, and it is nearly complete:

“New meetings of the task force will take place still in 2024 to address the few remaining issues before finalising the adoption process of all related documents.”

Guidance Documents

Manufacturer Incident Report Q&A Document

The current MIR Q&A will be revised to incorporate changes made to the MIR form. Regarding status:

“A small dedicated task force composed of Austria, Netherlands and COM [the Commission] was set up to draft a revised document before opening up at a certain stage for consultation with industry organisations.”

MDR Vigilance Guidance on Articles 87 & 89

A dedicated Task Force composed of Competent Authorities is working on this guidance. Input will be requested from stakeholders in 2025 through consultations.

Manufacturer Trend Report Q&A Document

It is nearly complete:

“New meetings of the task force will take place still in 2024 to address the few remaining issues before finalising the adoption process of all related documents.”

Post-Market Surveillance (PMS) Guidance

It is nearing completion:

“The task force Chair (Netherlands) presented the positive outcome of the written procedure for PMSV [Post-Market Surveillance and Vigilance] agreement with a few editorial change requests. The comments received have been sent to the taskforce for final corrections.

Following the PMSV CAs WG [Post-Market Surveillance and Vigilance Competent Authorities Working Group] agreement of the draft PMS guidance, COM [the Commission] will launch its MDCG endorsement through written procedure.”

IVDR Periodic Safety Update Report (PSUR) Guidance

The work to incorporate the IVDR into the PSUR guidance was temporarily stopped due to other urgent topics. The Commission confirmed to stakeholders, however, that 1) no major modifications are expected, and 2) the task force meeting would resume early 2025 to finalize revision to the guidance.

EUDAMED Vigilance Module

The Commission confirmed that while there are still several issues that need to be fixed, the “general timeline for the EUDAMED Vigilance module release for mandatory use should in principle not be impacted”.

Stakeholders raised awareness that manufacturers will need to update their processes to use the EUDAMED vigilance module. For some companies, this may require significant time and resources. The Commission reminded stakeholders that manufacturers will have a 6-month transition period to amend their processes. Further, that manufacturers can utilize the EUDAMED Playground to help them to better understand the system / steps.

MDCG 2023-3 Rev. 2

A new revision of MDCG 2023-3 (Q&A on Vigilance Terms and Concepts) is available: HERE

The changes are minor: