Regulatory Open Forum

Hello, all you smart people--

I have a few questions about third country vigilance/reporting requirements:

1. Europe: Based on the EU MDR, manufacturers are required to report to the relevant EU competent authority any field safety corrective action undertaken in a third country that involves a device that is also made available on the EU market (Article 87(1)(b)). However, based on the lack of mention of a "third country" in Article 87(1)(a), it seems like a serious incident that occurs outside of the EU would not need to be reported to the competent authority. Do you agree that a serious incident only needs to be reported to the EU competent authority if it occurred in an EU Member State?
2. United States: Based on the US FDA guidance "Medical Device Reporting for Manufacturers" (Section 4.11), it appears that if a manufacturer is based in the US and a reportable adverse event occurs in a non-US jurisdiction, the manufacturer is still expected to submit a Medical Device Report to US FDA. Do you agree that US manufacturers are required to submit a Medical Device Report to US FDA for any event that meets US reporting requirements, whether the event occurred within the US or outside of it?
3. In your experience, do most regulators want to know about all reportable incidents/adverse events regardless of where the incident/event occurred? Or do they only want to know about incidents/events that occurred in their jurisdiction?

Thanks in advance!

Hi Caitlin,

I agree with your assessment #1 regarding Europe's Union.

I agree, and the FDA absolutely unequivocally agrees, with your assessment #2 regarding the U.S. FDA.  But I would clarify that this FDA requirement is in regards to a manufacturer's device that is legally marketed (i.e., cleared/approved for marketing) in FDA's jurisdiction.  If the device is not legally marketed in the FDA's jurisdiction, then a foreign adverse event need not be reported to the FDA.

My experience is that most regulators' requirements are more like Europe's than FDA's.

Hello, all you smart people--

I have a few questions about third country vigilance/reporting requirements:

1. Europe: Based on the EU MDR, manufacturers are required to report to the relevant EU competent authority any field safety corrective action undertaken in a third country that involves a device that is also made available on the EU market (Article 87(1)(b)). However, based on the lack of mention of a "third country" in Article 87(1)(a), it seems like a serious incident that occurs outside of the EU would not need to be reported to the competent authority. Do you agree that a serious incident only needs to be reported to the EU competent authority if it occurred in an EU Member State?
2. United States: Based on the US FDA guidance "Medical Device Reporting for Manufacturers" (Section 4.11), it appears that if a manufacturer is based in the US and a reportable adverse event occurs in a non-US jurisdiction, the manufacturer is still expected to submit a Medical Device Report to US FDA. Do you agree that US manufacturers are required to submit a Medical Device Report to US FDA for any event that meets US reporting requirements, whether the event occurred within the US or outside of it?
3. In your experience, do most regulators want to know about all reportable incidents/adverse events regardless of where the incident/event occurred? Or do they only want to know about incidents/events that occurred in their jurisdiction?

Thanks in advance!

Hello, all you smart people--

I have a few questions about third country vigilance/reporting requirements:

1. Europe: Based on the EU MDR, manufacturers are required to report to the relevant EU competent authority any field safety corrective action undertaken in a third country that involves a device that is also made available on the EU market (Article 87(1)(b)). However, based on the lack of mention of a "third country" in Article 87(1)(a), it seems like a serious incident that occurs outside of the EU would not need to be reported to the competent authority. Do you agree that a serious incident only needs to be reported to the EU competent authority if it occurred in an EU Member State?
2. United States: Based on the US FDA guidance "Medical Device Reporting for Manufacturers" (Section 4.11), it appears that if a manufacturer is based in the US and a reportable adverse event occurs in a non-US jurisdiction, the manufacturer is still expected to submit a Medical Device Report to US FDA. Do you agree that US manufacturers are required to submit a Medical Device Report to US FDA for any event that meets US reporting requirements, whether the event occurred within the US or outside of it?
3. In your experience, do most regulators want to know about all reportable incidents/adverse events regardless of where the incident/event occurred? Or do they only want to know about incidents/events that occurred in their jurisdiction?

Thanks in advance!

Hello, all you smart people--

I have a few questions about third country vigilance/reporting requirements:

1. Europe: Based on the EU MDR, manufacturers are required to report to the relevant EU competent authority any field safety corrective action undertaken in a third country that involves a device that is also made available on the EU market (Article 87(1)(b)). However, based on the lack of mention of a "third country" in Article 87(1)(a), it seems like a serious incident that occurs outside of the EU would not need to be reported to the competent authority. Do you agree that a serious incident only needs to be reported to the EU competent authority if it occurred in an EU Member State?
2. United States: Based on the US FDA guidance "Medical Device Reporting for Manufacturers" (Section 4.11), it appears that if a manufacturer is based in the US and a reportable adverse event occurs in a non-US jurisdiction, the manufacturer is still expected to submit a Medical Device Report to US FDA. Do you agree that US manufacturers are required to submit a Medical Device Report to US FDA for any event that meets US reporting requirements, whether the event occurred within the US or outside of it?
3. In your experience, do most regulators want to know about all reportable incidents/adverse events regardless of where the incident/event occurred? Or do they only want to know about incidents/events that occurred in their jurisdiction?

Thanks in advance!

Hello, all you smart people--

I have a few questions about third country vigilance/reporting requirements:

1. Europe: Based on the EU MDR, manufacturers are required to report to the relevant EU competent authority any field safety corrective action undertaken in a third country that involves a device that is also made available on the EU market (Article 87(1)(b)). However, based on the lack of mention of a "third country" in Article 87(1)(a), it seems like a serious incident that occurs outside of the EU would not need to be reported to the competent authority. Do you agree that a serious incident only needs to be reported to the EU competent authority if it occurred in an EU Member State?
2. United States: Based on the US FDA guidance "Medical Device Reporting for Manufacturers" (Section 4.11), it appears that if a manufacturer is based in the US and a reportable adverse event occurs in a non-US jurisdiction, the manufacturer is still expected to submit a Medical Device Report to US FDA. Do you agree that US manufacturers are required to submit a Medical Device Report to US FDA for any event that meets US reporting requirements, whether the event occurred within the US or outside of it?
3. In your experience, do most regulators want to know about all reportable incidents/adverse events regardless of where the incident/event occurred? Or do they only want to know about incidents/events that occurred in their jurisdiction?

Thanks in advance!

Hello, all you smart people--

I have a few questions about third country vigilance/reporting requirements:

1. Europe: Based on the EU MDR, manufacturers are required to report to the relevant EU competent authority any field safety corrective action undertaken in a third country that involves a device that is also made available on the EU market (Article 87(1)(b)). However, based on the lack of mention of a "third country" in Article 87(1)(a), it seems like a serious incident that occurs outside of the EU would not need to be reported to the competent authority. Do you agree that a serious incident only needs to be reported to the EU competent authority if it occurred in an EU Member State?
2. United States: Based on the US FDA guidance "Medical Device Reporting for Manufacturers" (Section 4.11), it appears that if a manufacturer is based in the US and a reportable adverse event occurs in a non-US jurisdiction, the manufacturer is still expected to submit a Medical Device Report to US FDA. Do you agree that US manufacturers are required to submit a Medical Device Report to US FDA for any event that meets US reporting requirements, whether the event occurred within the US or outside of it?
3. In your experience, do most regulators want to know about all reportable incidents/adverse events regardless of where the incident/event occurred? Or do they only want to know about incidents/events that occurred in their jurisdiction?

Thanks in advance!