July 10th, 2019 the European Commission published “Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8”. This guidance complements the MEDDEV 2.12-1 rev.8, dated January 2013.
The “Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8”:
- Clarifies the existing definitions for field safety corrective action and field safety notice.
- Introduces device specific vigilance guidance which provide additional information to manufacturers that can assist them to identify incidents and complaints associated with specific medical devices, and to help them determine if a type of incident is reportable to the Competent Authority. Device Specific Vigilance Guidance documents have been developed and published for devices for cardiac ablation and for coronary stents and associated delivery systems.
- Introduces the new Manufacturer’s Incident Report (MIR) and the new template for Field Safety Notice (FSN). The guidance clearly states that the updated version of the MIR Form (version 7.2) will become mandatory from January 2020.
- Provides further clarification on Field Safety Corrective Actions (FSCA) section 5.4.4 MEDDEV 2.12-1 rev. 8.
- Provides further clarification on the Field Safety Notice section 188.8.131.52 of MEDDEV 2.12-1 rev. 8.
- Provides further detail in relation to the area of the coordination of vigilance issues amongst Competent Authorities and clarifies the differences between the EU NCAR exchange and the IMDRF NCAR exchange.
What does this mean to you?
This new guidance document should be read in conjunction with the MEDDEV 2.12-1 rev. 8 Guidelines on a medical devices vigilance system, from January 2013.
The most important change to implement is the new MIR form in which the IMDRF coding/terminology for adverse events has been introduced.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.