The European Commission issued new guidance on when devicemakers operating in the EU need to issue Field Safety Corrective Actions and how they should prepare field safety notices.
The guidance introduces a new manufacturer incident report and a new template for field safety notices. It also introduces device-specific vigilance guidance and provides more detail on coordinating vigilance activities with regulators.
Under the new EU regulations, devicemakers must have procedures to review post-market experience to ensure that any needed corrective actions are carried out, and they are required to report incidents and recalls to their national authorities.
But the directives and the guidance in MEDDEV 2.12-1 rev. 8 contain “very little detail on the vigilance obligations for manufacturers,” according to attorneys at Sidley. As a result, many manufacturers find that vigilance reporting can be a confusing.
The additional guidance removes a requirement for the national competent authority to consult with manufacturers when preparing a National Competent Authority (NCA) report. It may not always be appropriate or justified for the manufacturer to be consulted or informed of a NCA report in cases where there is a serious risk to the safety of patients or other users but where no corrective action has yet been established, Sidley noted.
However, the guidance does require that the manufacturer always be consulted when an NCA report is prepared in response to a Field Safety Corrective Action being performed by the manufacturer. When a manufacturer is consulted, the NCA must provide a deadline for comments.
The Commission clarifies that “it is both the nature of the action taken, and the reason giving rise to the need for the action which defines whether an action is a FSCA.”
The manufacturer’s incident report has also been updated and includes some new concepts. It introduces new structures and International Medical Device Regulators Forum coding and terminology. It also includes a definition of similar incidents and requires trend data for those. Other new concepts that come into force in January 2020 include a unique device identification (UDI) system and the concept of a single registration number (SRN).
The guidance explains the role of a vigilance taskforce in communicating with other stakeholders including the manufacturer and when such a taskforce should be used.
“For the more involved and complex issues, the establishment of a specific vigilance taskforce may be required,” the guidance says, noting that the composition of such a taskforce should include the competent authority with the original concern as well as other competent authorities, the manufacturer or its authorized representative, and notified bodies.
Read the European Commission’s guidance here: www.fdanews.com/08-29-19-Guidance.pdf.