This position paper includes a definition of ‘systemic off-label use’ (device used repeatedly or continuously outside its approved intended purpose and indications) and of ‘unmet medical need’ (device has been used ‚unsystematically‘ meaning randomly). Although the definition does not define a proportion of cases that would be considered ‘systemic off-label use’, this definition provides more direction for manufacturers.
Furthermore, the paper clarifies the steps to take in case systemic off-label use or use for an unmet medical need has been observed. Systemic off-label use is typically identified as part of post-market clinical follow-up (PMCF) activities. In such a case, the manufacturer needs to take actions to reduce misuse, but also is expected to assess whether there is a need to cover this newly identified use for the medical purpose/indication of the device. It is noted that data obtained with PMCF on systemic off-label use is anecdotal evidence (and thus not sufficient clinical data), resulting in the need for a pre-market clinical study in case there is a need to cover this newly identified use for the medical purpose/indication.
In case the device is used for an unmet medical need, it may be possible to apply for derogation of conformity assessment procedures at competent authorities per article 59 of the MDR.Download the Paper