EC Issues Additional Guidance on Device Vigilance System
Posted 10 July 2019 | By
While highlighting an updated version of the manufacturer incident report (MIR) form that will become mandatory in January 2020, the European Commission (EC) issued guidance Tuesday on the medical device vigilance system under the EU’s medical device directive.
The January version of the MIR introduces the use of the adverse event terminology/coding harmonized via the International Medical Device Regulators Forum (IMDRF) and the use of unique device identification (UDI). The new MIR also introduces the concept of a single registration number (SRN), which will pre-populate a manufacturer’s details in the future Eudamed.
From January 2020, the current version of the MIR must be included in device manufacturers’ databases. Introducing the use of UDI and the SRN via the MIR comes in preparation for the future regulatory system under the EU’s medical device and in vitro
diagnostic regulations (MDR/IVDR). The EC posted
documents in March on UDI information for inclusion in Eudamed.
The EC’s latest guidance document on the medical device vigilance system also identifies a set of five circumstances for which national competent authority is needed and the four types of situations where information—under the National Competent Authority Report (NCAR)—should be disseminated between national competent authorities. The EC clarifies differences between the IMDRF NCAR and the EU NCAR exchanges. Members states must have “the appropriate/necessary bilateral confidentiality agreements” for the IMDRF NCAR exchange.
Other clarifications in the new EC guidance relates to definitions, field safety corrective actions, the content of a field safety notice and the role of a vigilance taskforce, among others.
Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8