MDSS News & Views

The following important vigilance documents have been published on the European website:

• Additional guidance on the MEDDEV 2.12/1 rev.8 
• Device specific vigilance guidance (if applicable):
  • Cardiac ablation vigilance reporting guidance
  • Coronary stents vigilance reporting guidance
  • Cardiac implantable electronic devices (CIED)
  • Breast implants
• New manufacturer incident report (version 7.2)

The new Manufacturer’s Incident Report (MIR) Form has been updated and a copy of the latest version (version 7.2) and detailed guidance/ help text that may assist in completing the form are available on the Commission website.

Based on the additional guidance on the MEDDEV 2.12/1 rev.8  section 4, the current version of the MIR Form included a number of new concepts:

• The information is presented in a new structure.
• Introduces international IMDRF coding/ terminology.
• Introduces a definition of similar incidents and requires similar incidents trend data in a tabular format.
• In preparation for the future EU MDR it also introduces (not mandatory yet):
  • the concept of SRN which will be utilized greatly in the future under the new regulations.
  • the use of UDI.

The updated version of the MIR Form V 7.2 will become mandatory from January 2020.

However, if you are a manufacturer and have already adapted your IT system to version 7.1, you may use this version until the end of March 2020.

For more detailed information, please do not hesitate to contact your MDSS team!