Regulatory Open Forum

I'm looking for a consensus on the reporting of CAPAs in PSURs.

MDCG 2022-21 Guidance for PSURs references Articles 83.4 and 86 in regard to CAPA reporting.

MDR Article 83.4 states:

If, in the course of the post-market surveillance, a need for preventive or corrective action or both is identified, the manufacturer shall implement the appropriate measures and inform the competent authorities concerned and, where applicable, the notified body. Where a serious incident is identified or a field safety corrective action is implemented, it shall be reported in accordance with Article 87 [Vigilance]. [bold sections are my emphasis]

Further, the MDCG 2022-21 states the information provided for each CAPA to be reported should include the root cause and notes that IMDRF terms/codes can be used. The only IMDRF codes available are specifically related to investigation and causes of adverse events.

This makes me think that we do not have to report CAPAs in the PSUR that were the result of issues/non-conformances identified during manufacturing process monitoring or as a result of an audit.

Does this make sense?

Hi John:

I take your point, however my position would be MDCG documents are only guidance and (although sanctioned by the EC) are not legally binding. They inform my thinking and interpretation, but do not dictate it. An issue may come to light during manufacture that significantly affects my understanding of a product's safety or performance, and this, I would want to communicate in the PSUR. If I write the PSUR, I have an ethical duty to include what I think is important, regardless of whether the "letter of the law" requires it.

My feeling is to err on the side of caution and "over-report", rather than risk over-interpreting general guidance. Particularly, as we are still so early in the life of the regulations.

I am very interested to hear what other think.

Neil

I'm looking for a consensus on the reporting of CAPAs in PSURs.

MDCG 2022-21 Guidance for PSURs references Articles 83.4 and 86 in regard to CAPA reporting.

MDR Article 83.4 states:

If, in the course of the post-market surveillance, a need for preventive or corrective action or both is identified, the manufacturer shall implement the appropriate measures and inform the competent authorities concerned and, where applicable, the notified body. Where a serious incident is identified or a field safety corrective action is implemented, it shall be reported in accordance with Article 87 [Vigilance]. [bold sections are my emphasis]

Further, the MDCG 2022-21 states the information provided for each CAPA to be reported should include the root cause and notes that IMDRF terms/codes can be used. The only IMDRF codes available are specifically related to investigation and causes of adverse events.

This makes me think that we do not have to report CAPAs in the PSUR that were the result of issues/non-conformances identified during manufacturing process monitoring or as a result of an audit.

Does this make sense?

Hello John,

I have the same opinion as you and Neil on what corrective actions or preventive actions would be reported in a Periodic Safety Update Report (PSUR).  Reporting every single corrective action or preventive action in the PSUR would water down the report and information get lost in the noise.  For me, I read the EU MDR regulation and the MDCG guidance as corrective actions which are significant in context of the product in the field.  This means obviously corrective actions associated with serious incident reports or Field Service Corrective Actions (FSCA) would be identified in the PSUR so these can be traced back through the quality system.  Including corrective actions for incoming material rejections or issues occurring during manufacturing because some equipment needed service, would in my opinion not be relevant for the PSUR.  Mostly for me the PSUR is in context of post market activities.  This means if there is a corrective action or preventive action which is not related to post market activities, then it would not be summarised in the PSUR.  There may be some which may be needed in the PSUR to help reference or trace issues which occur through PSURs, which could probably be added, but adding a corrective action where a supplier provided the wrong parts, probably not needed in the PSUR.

Hi John:

I take your point, however my position would be MDCG documents are only guidance and (although sanctioned by the EC) are not legally binding. They inform my thinking and interpretation, but do not dictate it. An issue may come to light during manufacture that significantly affects my understanding of a product's safety or performance, and this, I would want to communicate in the PSUR. If I write the PSUR, I have an ethical duty to include what I think is important, regardless of whether the "letter of the law" requires it.

My feeling is to err on the side of caution and "over-report", rather than risk over-interpreting general guidance. Particularly, as we are still so early in the life of the regulations.

I am very interested to hear what other think.

Neil

I'm looking for a consensus on the reporting of CAPAs in PSURs.

MDCG 2022-21 Guidance for PSURs references Articles 83.4 and 86 in regard to CAPA reporting.

MDR Article 83.4 states:

If, in the course of the post-market surveillance, a need for preventive or corrective action or both is identified, the manufacturer shall implement the appropriate measures and inform the competent authorities concerned and, where applicable, the notified body. Where a serious incident is identified or a field safety corrective action is implemented, it shall be reported in accordance with Article 87 [Vigilance]. [bold sections are my emphasis]

Further, the MDCG 2022-21 states the information provided for each CAPA to be reported should include the root cause and notes that IMDRF terms/codes can be used. The only IMDRF codes available are specifically related to investigation and causes of adverse events.

This makes me think that we do not have to report CAPAs in the PSUR that were the result of issues/non-conformances identified during manufacturing process monitoring or as a result of an audit.

Does this make sense?

I'm looking for a consensus on the reporting of CAPAs in PSURs.

MDCG 2022-21 Guidance for PSURs references Articles 83.4 and 86 in regard to CAPA reporting.

MDR Article 83.4 states:

If, in the course of the post-market surveillance, a need for preventive or corrective action or both is identified, the manufacturer shall implement the appropriate measures and inform the competent authorities concerned and, where applicable, the notified body. Where a serious incident is identified or a field safety corrective action is implemented, it shall be reported in accordance with Article 87 [Vigilance]. [bold sections are my emphasis]

Further, the MDCG 2022-21 states the information provided for each CAPA to be reported should include the root cause and notes that IMDRF terms/codes can be used. The only IMDRF codes available are specifically related to investigation and causes of adverse events.

This makes me think that we do not have to report CAPAs in the PSUR that were the result of issues/non-conformances identified during manufacturing process monitoring or as a result of an audit.

Does this make sense?

I'm looking for a consensus on the reporting of CAPAs in PSURs.

MDCG 2022-21 Guidance for PSURs references Articles 83.4 and 86 in regard to CAPA reporting.

MDR Article 83.4 states:

If, in the course of the post-market surveillance, a need for preventive or corrective action or both is identified, the manufacturer shall implement the appropriate measures and inform the competent authorities concerned and, where applicable, the notified body. Where a serious incident is identified or a field safety corrective action is implemented, it shall be reported in accordance with Article 87 [Vigilance]. [bold sections are my emphasis]

Further, the MDCG 2022-21 states the information provided for each CAPA to be reported should include the root cause and notes that IMDRF terms/codes can be used. The only IMDRF codes available are specifically related to investigation and causes of adverse events.

This makes me think that we do not have to report CAPAs in the PSUR that were the result of issues/non-conformances identified during manufacturing process monitoring or as a result of an audit.

Does this make sense?

Hi John

Already a couple of insightful comments have been made to your question. 

I take a slightly high level view. The question in my mind is "what is the purpose of PSUR"? Why is it required?

My understanding is that there is a need for better transparency, mostly to competent authorities, so they can have a better sense of ongoing activities that affect safety and effectiveness of the product in the market. By requiring such reporting, I think the expectation is that there would be good follow up to safety related adverse events, good quality investigations would be conducted, and appropriate follow up actions would be taken.

In particular, your question points to CAPAs that may originate from internal NCs, including those from audits. I am assuming that your CAPA determination process also includes a risk assessment based on the nature of the NC. I am also assuming that after each CAPA is completed, risk files are updated appropriately. If so, this should provide sufficient evidence (in my view) of a well functioning QMS that also satisfies the requirements of risk management. Personally, I don't see why you would want to include these CAPAs and resulting actions in your PSUR, which is essentially an external-facing document. But then, it is only my view and  I respect other opinions. 

Best regards

I'm looking for a consensus on the reporting of CAPAs in PSURs.

MDCG 2022-21 Guidance for PSURs references Articles 83.4 and 86 in regard to CAPA reporting.

MDR Article 83.4 states:

If, in the course of the post-market surveillance, a need for preventive or corrective action or both is identified, the manufacturer shall implement the appropriate measures and inform the competent authorities concerned and, where applicable, the notified body. Where a serious incident is identified or a field safety corrective action is implemented, it shall be reported in accordance with Article 87 [Vigilance]. [bold sections are my emphasis]

Further, the MDCG 2022-21 states the information provided for each CAPA to be reported should include the root cause and notes that IMDRF terms/codes can be used. The only IMDRF codes available are specifically related to investigation and causes of adverse events.

This makes me think that we do not have to report CAPAs in the PSUR that were the result of issues/non-conformances identified during manufacturing process monitoring or as a result of an audit.

Does this make sense?