The European Commission has posted on their website version 7.2 of the template for a Manufacturer Incident Report (MIR), and its accompanying help text on how to complete the form. This template will become mandatory as of January 1st, 2020 for incidents under the MDD/AIMDD or IVDD, or for serious incidents under the MDR or IVDR.
The changes introduced in v7.2 of the MIR include mismatch fixes and the addition of the EUDAMED DI as alternative to Basic-UDI-DI and EUDAMED ID as alternative to UDI-DI for legacy devices.
In addition, the European Commission released two new Device Specific Vigilance Guidance (DSVG) documents. DSCG 03 on Cardiac Implantable Electronic Devices (CIED) and DSVG 04 on Breast Implants.
These guidance documents on cardiac implantable electronic devices and breast implants offer support to the manufacturers of these type of devices on how to determine if an incident is reportable. The documents provide examples of what should be reported as an incident, what can be included in periodic summary reports and what should be reported at the time of a statistically significant increase in the frequency or severity of incidents.
What does this mean to you?
The first version of this MIR form was introduced on January 1st, 2019. A 12-month transition period is foreseen before the new form becomes mandatory January 1st, 2020. Until that day you can continue to use the current “old” MIR form. As a company it is vital that you start setting up your systems to allow completion of the elaborated form, including the introduction of the IMDRF AER codes into your systems.
If you are a manufacturer of cardiac implantable electronic devices or breast implants these new DSVG documents can provide support in your vigilance process and help assess when to report incidents.
If you require more in-depth information, training or support in implementing the necessary changes, please contact us.
