I agree with you that medium severity could be seen as more impactfull than a high severity.
In the RDM, in UE, another requirement has been added, please let me copy here the extract:
Article 88 - Trend reporting
1. Manufacturers shall report, by means of the electronic system referred to in Article 92, any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side-effects that could have a significant impact on the benefit-risk analysis referred to in Sections 1 and 8 of Annex I and which have led or may lead to risks to the health or safety of patients, users or other persons that are unacceptable when weighed against the intended benefits. The significant increase shall be established in comparison to the foreseeable frequency or severity of such incidents in respect of the device, or category or group of devices, in question during a specific period as specified in the technical documentation and product information.
So, this requirement could be an "answer" to the way to manage significative rise of frequency (and of severity) without being a serious incident.
Hi Naveen,
I agree with you that medium severity could be seen as more impactfull than a high severity.
In the RDM, in UE, another requirement has been added, please let me copy here the extract:
Article 88 - Trend reporting
1. Manufacturers shall report, by means of the electronic system referred to in Article 92, any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side-effects that could have a significant impact on the benefit-risk analysis referred to in Sections 1 and 8 of Annex I and which have led or may lead to risks to the health or safety of patients, users or other persons that are unacceptable when weighed against the intended benefits. The significant increase shall be established in comparison to the foreseeable frequency or severity of such incidents in respect of the device, or category or group of devices, in question during a specific period as specified in the technical documentation and product information.
So, this requirement could be an "answer" to the way to manage significative rise of frequency (and of severity) without being a serious incident.
I made a mistake in the 1st sentence : "medium severity could be seen as more impactfull as high ** FREQUENCY ** - sorry ;-)
Indeed Stephanie - we need to pay attention to both S and POH; not just one or the other. Thank you for sharing.
This review is insightful, substantive, and thought-provoking. Well done!
Thank you Steve!