Where to submit Adverse Events Reports in Europe

image182

Involved In Discussions
#1
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!
 
Elsmar Forum Sponsor

dgrainger

Trusted Information Resource
#2
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
#3
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
#5
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
#6
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
#7
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
#8
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.
 
Thread starter Similar threads Forum Replies Date
I Where do we submit the FAA Preapplication forms? Federal Aviation Administration (FAA) Standards and Requirements 1
N Where to find Regulations for Reprocessing and Reuse of Single-Use Devices Other Medical Device Related Standards 0
H Where to get EK MED 1927/16 Other Medical Device Regulations World-Wide 3
D Where to find Guidance Class II Amendment Canada Medical Device Regulations 0
O EN 301 489-1 and EN 301 489-17 - Where do we get the information of the Published versions? CE Marking (Conformité Européene) / CB Scheme 1
A AS9100 Training - Where do I start? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
qualprod Records where apply and stop recording everything? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
G Gage R&R - Where am I going wrong? Part of a FAIR submission (Aerospace) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
R Where does IATF 16949 address Process mapping? IATF 16949 - Automotive Quality Systems Standard 3
C Where to place CE/label in Sterile IVD EU Medical Device Regulations 1
G New to ISO 9001 - Where to begin? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
BeaBea Interesting Discussion Where Does Marketing/ Advertisement of Products fit in to ISO 9001? Process Maps, Process Mapping and Turtle Diagrams 39
K No IFU, where the requirements would go? EU Medical Device Regulations 5
T Assessing Hazard-Related Use Scenarios where control measures exist through standards IEC 62366 - Medical Device Usability Engineering 25
J Where to Place Process Maps in our Documentation? Process Maps, Process Mapping and Turtle Diagrams 4
GreatNate Where to get a KPI dashboard for QMS processes Quality Tools, Improvement and Analysis 5
I Where can I beg, steal (just kidding of course) or borrow good training material on the ISO 9001:2015 standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A Implementing ISO 20000-1 - Where to start Other ISO and International Standards and European Regulations 2
D Where does "as far as possible" stop? FMEA - EN 14971 ISO 14971 - Medical Device Risk Management 29
qualprod Statistics - Where to start in ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
H Calibration of InfraRan Vapor Analyzer - where to get calibration for SF6 General Measurement Device and Calibration Topics 2
L Clause 0.4 of ISO 9001 and EHS - Where should I stop the inclusion of EHS in my QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M Where can I find examples of PPAP? APQP and PPAP 6
A What if Contract Manufacturers does not have an ISO 13485 certificate? Where will the NB audit take place, at legal mfg. site or contract mfg. site? Other Medical Device Regulations World-Wide 3
J Where can I find the latest update to Reach and ROHS? REACH and RoHS Conversations 7
D Where (in US) can I get the VDA Auditor Edition book? VDA Standards - Germany's Automotive Standards 3
S Where to get online AS standard audit certification classes? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
J Where I can get a copy of either the 3rd or 4th edition of UL544? Other Medical Device Regulations World-Wide 7
G Where to find Proficiency Test provider for photometrics (spectral %R, %T, photo density) General Measurement Device and Calibration Topics 9
Marc Quiz - Where did the idea of an assembly line come from? Coffee Break and Water Cooler Discussions 4
F Quality Objectives - Where in the QMS Quality Objectives should be located ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M Where to obtain a calibrated DICOM image? ISO 13485:2016 - Medical Device Quality Management Systems 1
R Where to get information - M6 per WA900 Manufacturing and Related Processes 1
S Where did FDA 510(K) form 3654 go? Other US Medical Device Regulations 1
W Where to begin with an ISO 9001:2015 internal audit Internal Auditing 13
D China - Where I can get NMPA complete structure/organogram chart and GB/YY format list China Medical Device Regulations 1
D Where does FMEA fit in your ISO 14971 Risk Management process? ISO 14971 - Medical Device Risk Management 13
CCaantley Where to get a good test indicator stand for a granite surface plate General Measurement Device and Calibration Topics 8
I ESD - Dissipative foam on a seat for where the people sit at benches Manufacturing and Related Processes 6
C In cases where users of an electronic system change their names Qualification and Validation (including 21 CFR Part 11) 6
P Warning Letter 1999 - Where does the FDA make older warning letters available? US Food and Drug Administration (FDA) 4
Rameshwar25 Where is Personnel Safety in IATF 16949:2016 IATF 16949 - Automotive Quality Systems Standard 2
A Where are the rules for when a repeat minor nonconformance becomes a major? IATF 16949 - Automotive Quality Systems Standard 36
S Medical device mobile app UDI - Where is the UDI labelled? Other US Medical Device Regulations 1
G Where to buy Medical Grade Transformer IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
Y Where can I get 14 Layers PCB with BGA 0.2MM Space? Buy, Sell or Trade - NO Commercial Advertisements 0
R ASQ, CQI,............where else ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 2
G Where to list chain of traceability? ISO 17025 related Discussions 6
M AS9100 - Where to start - Small company (10 employees) and I am the Quality Dept. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 45
S Where to keep Enterprise Resource Planning software (ERP) Validation Records ISO 13485:2016 - Medical Device Quality Management Systems 1

Similar threads

Top Bottom