The European Commission has released a document titled 'Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8', available from here.
The document provides additional guidance in relation to the Medical Device Vigilance System that is currently in operation under the Medical Devices Directives. The guidance should complement and be used in conjunction with MEDDEV 2.12-1 rev. 8, 2013, the Commission advises.
Clarifies some of the existing definitions.
Introduces a new Manufacturer’s Incident Report (MIR) and the new template for Field Safety Notices.
Introduces device specific vigilance guidance.
Provides further detail in relation to the area of the coordination of vigilance issues amongst Competent Authorities.
Clarifies the differences between the EU NCAR exchange and the IMDRF NCAR exchange.
Highlights that the most recent revision of all of the forms that currently support the Medical Device Vigilance System can now be found on the EU commission website rather the Annexes of MEDDEV 2.12-1 rev. 8, 2013.
The document explains that the updated version of the MIR Form V 7.2 will become mandatory from January 2020, and adds that a Q&A document detailing the transition to the new form can be found on the commission website.
Commission updates MDR Notified Body status
16 July 2019
The European Commission has made available on its website a short PowerPoint presentation advising on the latest state of play with regard to the assessment of Notified Bodies under the Medical Devices Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/746).
The presentation, available from here, advises that 51 applications have now been received, 41 for the MDR and 10 for the IVDR. Preliminary assessment reports have been completed for 40 applications, with 17 CAPA plans being received.
The MDCG has recommended 4 new Notified Bodies to be designated, but the NANDO database has not yet been updated to identify which Notified Bodies are concerned.
In addition, the presentation reports that a further 5 Notified Bodies have had final opinions from the Joint Assessment Team, but these have not yet been reviewed and endorsed by the MDCG.