Where to submit Adverse Events Reports in Europe

image182

Involved In Discussions
Hello all

I'm getting a bit confused with regards to where we need to submit adverse event reports in Europe....
  • We are a UK based company
  • BSI is our notified body
  • MHRA is our national competent authority
  • We sell our devices into multiple countries in Europe

As an example. if we had an event occur in France and we decided to submit a report, how many places would we be required to submit the report to?

Our notified body (BSI)
BSI have a submission portal and I believe we are required to submit the report to them. I'm not sure if this is something unique to BSI or all notified bodies require this?

Our national competent authority (MHRA)
MEDDEV 2.12 guides us to submit the report to the "national competent authority so I would have presumed this would be the only place we would be required to submit to

The competent authority in the country where the incident took place (ANSM)
We've been contacted by our distributor and they have advised us that the ANSM require the event to be reported to them

Other competent authorities who receive the device?
If the device is sold to various countries, Germany, Italy etc.... then would we also need to submit the report to these countries too?

Ideally I would only like to submit one report to one location... but i'm getting worried that each report would need to be submitted to a large number of locations and cause a considerable amount of work...

Thanks in advance for the help!
 

dgrainger

Trusted Information Resource
From the MEDDEV - P22:
5.1.8 TO WHOM TO REPORT
In general, the report should be made to the National Competent Authority in the country of occurrence of the INCIDENT unless specified differently in this guideline.
 

chris1price

Trusted Information Resource
Hi

If the incident occured in EU, it should be notified to the Competent Authority of the country in which the event occurred. This will be the full report of the incident and invenstigations. They will take the lead in the investigation. (see meddev 2-12-1 section 5.2)

If it occured outside of EU, then report to your national CA.

You also need to notify all other EU countries in which the same product was sold, and your national CA if you havnt already done so. A copy of MEDDEV FSCA form and FSN in appropriate language. (see meddev 2-12-1 section 5.4.4.1)

If you dont sell to a specific country and don't notify them, you will probably get requests for information anyway.

Don't forget any non eu countriles where the device may have been sold, USA, Australia, Canada, etc. Also dont be surprised when you get requests for information from other countries such as Hong Kong and Singapore.

Notified bodies vary in their requirments, BSI do want notification, others may not. Check your contract with them.

Unfortunately, there isnt a single sentral location to send notifications. Under the new regulations, one may be created, but done hold your breath.

Chris
 

image182

Involved In Discussions
If the incident occured in EU, it should be notified to the Competent Authority of the country in which the event occurred. This will be the full report of the incident and invenstigations. They will take the lead in the investigation. (see meddev 2-12-1 section 5.2)

If it occured outside of EU, then report to your national CA.

You also need to notify all other EU countries in which the same product was sold, and your national CA if you havnt already done so. A copy of MEDDEV FSCA form and FSN in appropriate language. (see meddev 2-12-1 section 5.4.4.1)

So following the MEDDEV and submitting to the competent authority where the incident occurred is not sufficient?

If we sold to every country in Europe, we would need to submit the report to every competent authority?
 

chris1price

Trusted Information Resource
I'm believe so, 5.4.4.1 of the meddev says......

"The MANUFACTURER should issue a notification (see below) to the Competent Authorities
of all countries affected at the same time and also to the National Competent Authority
responsible for the MANUFACTURER or AUTHORISED REPRESENTATIVE. Use the
format recommended in annex 4."

Annex 4 is the FSCA form. The good news is that I have always filled it out in English and have not been asked for a translation. The FSN (which is also sent to customers) should be translated.
 

image182

Involved In Discussions
I'm believe so, 5.4.4.1 of the meddev says......

"The MANUFACTURER should issue a notification (see below) to the Competent Authorities
of all countries affected at the same time and also to the National Competent Authority
responsible for the MANUFACTURER or AUTHORISED REPRESENTATIVE. Use the
format recommended in annex 4."

Annex 4 is the FSCA form. The good news is that I have always filled it out in English and have not been asked for a translation. The FSN (which is also sent to customers) should be translated.

Isn't section 5.4.4.1 related to FSCA and not applicable for general reporting where a FSCA is not required?

5.1.8 is related to reporting incidents and states
"In general, the report should be made to the National Competent Authority in the country of occurrence of the INCIDENT unless specified differently in this guideline."

This suggests only sending the report to one CA

However, section 5.4.3 which deals with the final report states
"The report is made by the MANUFACTURER to the National Competent Authority(ies) to whom the MANUFACTURER sent the initial report. "

This suggests that we could have submitted to multiple CA?
 

dgrainger

Trusted Information Resource
Yes, section 5.4.4 relates to Field Safety Corrective Action.

Section 5.1 relates to incident reporting.

You would only send a final report to multiple NCAs if you had reported incidents in those NCAs.
 
Top Bottom