MDR Vigilance for Medical Devices
MDCG 2023-3 Questions and Answers published in February 2023 provide important info regarding the MDR Vigilance for Medical Devices as outlined in Section 2 of Chapter VII of the MDR.
Let’s start from the end and smack bang into the most crucial take-home advice. If you are an MDR manufacturer, you may need to update your company’s Vigilance procedure. Namely, many companies previously relied on MEDDEV 2/12-1 rev. 8, January 2013, which is, as guidance openly says (in the footnote, though), not applicable under the MDR anymore. In addition, there are some departures from ISO 14971:2019 (“use error”).
- The footnote info in this guidance is not less important than the info in the text, so don’t footloose it! Undoubtedly, the winner is: Guidelines on a Medical Devices Vigilance System, MEDDEV 2/12-1 rev. 8, January 2013 (applicable under the MDD), and AIMDD is not relevant anymore under the MDR (footnote 1), as we mentioned.
- Incidents (Article 2(64) MDR) are not reportable to competent authorities. Still, they must be documented, investigated, and reported (“Trend Reports” Article 88 MDR) to the competent authority(ies) of the Member State(s) in which the incidents occurred. The guidance still needs to clarify to whom to report if the incidents occurred in different Member States.
- If you cannot exclude that the incident could potentially have led to the “serious incident,” the incident must be considered serious.
- The manufacturer must report serious incidents to the relevant competent authority using the Manufacturer Incident Report (MIR), within the timelines outlined in Article 87(3) to (5) MDR: Any serious incident (no later than 15 calendar days); A serious public health threat (no later than 2 calendar days); Death or an unanticipated serious deterioration in a person’s state of health (no later than 10 calendar days).
- Expected undesirable side effects must be reported under the requirements for trend reporting (Article 88 MDR). This emphasizes the importance of carefully defining product’ expected undesirable side effects in the risk analysis.
- Suppose the manufacturer cannot demonstrate that a potentially serious incident is an expected undesirable side-effect within the deadlines set out in Article 87(3) to (5) MDR. In that case, it must submit a Manufacturer Incident report (MIR) within the reporting timelines.
Please don’t hesitate to contact us if you need any help writing Vigilance SOP or have any other questions on MDR Compliance.