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New adverse event terminology to be implemented in Europe starting from 2Q 2018

The European Competent Authorities are keen to receive codified information on adverse events already ahead of the date of application of the upcoming IVD and MD Regulations. The adverse event codes developed by the International Medical Device Regulators Forum (IMDRF) are scheduled to be implemented in the European vigilance reporting starting from 2Q 2018 with one year transition time until their official enforcement.

Manufacturers are strongly advised to start mapping their internal company codes to the IMDRF adverse event codes already released:

Event-type codes (published in April 2017)

· IMDRF Medical device problem codes (Annex A) + reference mapping

Evaluation codes / IMDRF Cause investigation (published in October 2017)

· Type of investigation (Annex B - 1 level) + reference mapping

· Investigation findings (Annex C - 3 levels) + reference mapping

· Investigation conclusion (Annex D - 2 level) + reference mapping

Patient outcome codes / IMDRF Patient Problem (planned publication in October 2018 or early 2019)

· Clinical signs, symptoms, and conditions (Annex E)

· Health impact (Annex F)

The revised Manufacturer Incident Reporting Form capturing the IMDRF nomenclature codes will be made available at the Commission website in 2Q of 2018.

The other main new element when filing a Vigilance report in the future is a request for trending data, more specifically the number of similar incidents and those of devices placed on the market. The reason for that is to provide evaluating Member States with a nominator and denominator in order to enable them to estimate the magnitude the reported issue.

The implementation of the above is foreseen to be completed within 12 months, by 2Q/3Q of 2019

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