MDR reporting and CAPA thoughts? Classifying Complaints on Risk

Jkc3usc12

Involved In Discussions
#1
System I am working with is classifying complaints on risk. If it is high risk and determine to report a CAPA is automatically initiated.

If a medwatch is received a 3500a is filled out no matter and again a CAPA is initiated.

MDR Reporting and CAPA have always been separate decisions for me in the past. I understand they can tie in together just not every time. Also reporting any medwatch received I have never done.

Thoughts?

Thanks
 
Last edited:
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#2
Usually, reportability is not directly related to risk classification (as it was done before by the regulator), it's simply a decision - does the event fits the criteria? If so, it's reportable, if not, it's not reportable.

As you mention CAPA (which is something that in practice do not exist, because you do not co CA PA or PA CA, you do either PA or correction, which may escalate to CA), maybe the problem is exactly in this distinction (which is a common problem in the US because people are really into the CAPA thing).

Normally, things would be like this:

- Event occurred.
- Is it reportable? If so, report.
- Is correction or any other immediate action necessary? If so, implement.
- What is the root cause of the event?
- Depending on the root cause, a CA may be necessary to prevent recurrence. It may be the case that a CA is not required.
 

Jkc3usc12

Involved In Discussions
#3
A risk matrix for complaints is used to determine risk and which if coded high is reported. If reported a PA or CA is automatically initiated.

I feel the investigation of the root cause would be the determination of the PA or the CA if needed. Not just because it is high risk.

Also your thoughts on receiving a medwatch and automatically initiating a 3500 and another PA or CA.
 

Marcelo

Inactive Registered Visitor
#4
A risk matrix for complaints is used to determine risk and which if coded high is reported. If reported a PA or CA is automatically initiated.
A report has to be submitted (I'm using a manufacturer as an example) when the manufacturer "they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur."

This has nothing to do with risk classification or analysis. It's either fir the trigger or not.

I feel the investigation of the root cause would be the determination of the PA or the CA if needed. Not just because it is high risk.
If the event already occurred, there can be no PA, as PA if before something happen. The investigation of the root cause (after any correction or other immediate action) would then be used to determine if a CA is required.
 

Jkc3usc12

Involved In Discussions
#5
I agree with you. The risk assessment is to help determine a potentially reportable incident. I just having a hard time saying that every reportable event leads to the capa process and also determining to report is based solely off the risk matrix. Not actually what happened.

I also have a hard time reporting when any medwatch is received which also then goes through the capa process.

I am in the process of trying to steer this away from the direction they are in.

Just seeing if my thoughts are off base?
 

Marcelo

Inactive Registered Visitor
#6
I agree with you. The risk assessment is to help determine a potentially reportable incident. I just having a hard time saying that every reportable event leads to the capa process and also determining to report is based solely off the risk matrix. Not actually what happened.

I also have a hard time reporting when any medwatch is received which also then goes through the capa process.

I am in the process of trying to steer this away from the direction they are in.

Just seeing if my thoughts are off base?
I think you are in the right path.

As I mention before, the problem seems to be in the concept of CAPA. A lot of people thinks that a CA is always required when a problem is found, which is not true. ISO 13485 makes it more clear, because the text in the CFR is misleading.

An correction or other immediate action is required after an NC is detected (see 8.3.2 of ISO 13485).

After that, you need to evaluate the root cause of the NC/complaint (8.5.2 b) of ISO 13485).

Then you need to device if there's a need to escalate to a CA or not (8.5.2 c) of ISO 13485).
 

Jkc3usc12

Involved In Discussions
#7
Yes those steps make sense.

You agree that there can be MDR reporting without CA?

The view of risk dictates everything so one cant go without the other. high risk report and capa. Low risk nether.
 

Jkc3usc12

Involved In Discussions
#9
They view of risk dictates everything so one cant go without the other. high risk report and capa. Low risk nether.

So there is no possible MDR reporting without a CAPA being issued. Its ether both or nether. If the complaint is deemed high risk its reported and a capa.

Same thing with a medwatch received will automatically be reported and a CAPA issued.
 

Marcelo

Inactive Registered Visitor
#10
They view of risk dictates everything so one cant go without the other. high risk report and capa. Low risk nether.

So there is no possible MDR reporting without a CAPA being issued. Its ether both or nether. If the complaint is deemed high risk its reported and a capa.

Same thing with a medwatch received will automatically be reported and a CAPA issued.
Yes, I understood what you said, but to do it this way does not make any sense.
 
Thread starter Similar threads Forum Replies Date
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
T Trend Reporting under the EU MDR EU Medical Device Regulations 29
L MDR (Medical Device Reporting) under 21 CFR Part 803 Other US Medical Device Regulations 5
B Is there a MDR (Medical Device Reporting) equivalent in China ? China Medical Device Regulations 1
C New draft MDR reporting guidance Other US Medical Device Regulations 1
R MDR Reporting for event with RUO instrument 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S MDR (Medical Device Reporting) Justification - Canned Statements Other US Medical Device Regulations 2
E Post Inspection Regulatory Action by US FDA - 21 CFR 803 - MDR Reporting Other US Medical Device Regulations 4
E Reporting Requirements - Report to US FDA if a MDR event happened outside US Other US Medical Device Regulations 3
L Interpretation of MDR Reportable Event - FDA guidance on Medical Device Reporting 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
W MDR Reporting - How to interpret requirements for MDR Other US Medical Device Regulations 14
Q When to File an MDR (Medical Device Reporting) For Incidents in Foreign Countries 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
M Reworking MDD product w MDR labeling CE Marking (Conformité Européene) / CB Scheme 0
A MDR and Poland EU Medical Device Regulations 6
Ed Panek Invitation to the MDR Dance EU Medical Device Regulations 5
M EU MDR language-Translation requiremens CE Marking (Conformité Européene) / CB Scheme 1
I What are suitable indicators and threshold values in MDR/IVDR? Medical Device and FDA Regulations and Standards News 3
A Sell-off legacy devices MDR EU Medical Device Regulations 0
A Eudamed actor registrations if you change AR for MDR product EU Medical Device Regulations 0
Ed Panek Which choice of the following most closely matches the MDR compliance of your company? EU Medical Device Regulations 0
K Definition of SAE under MDR EU Medical Device Regulations 3
Q Harmonised Standards (EN ISO 13485 / EN ISO 14971) in MDR (2017/745/EU) ISO 13485:2016 - Medical Device Quality Management Systems 3
Ed Panek Clarity from EC on Importer/Distributor roles in MDR EU Medical Device Regulations 9
Pmarszal BS EN 20417:2021 - Implementation Timeline Aligned With MDR? Other ISO and International Standards and European Regulations 1
T Dental lab acrylics and MDR EU Medical Device Regulations 0
S Biggest issues when producing MDR compliant Technical Files / DD EU Medical Device Regulations 4
A Declaring Conformity with MDR Article 120(3) for an MDD Legacy Device EU Medical Device Regulations 1
D EU MDR - Change of device name (legacy device) EU Medical Device Regulations 4
J Technical Documentation as per MDR / subpoint 6.1 EU Medical Device Regulations 3
M EU MDR - Retrospective Study for expanding indications of a legacy device EU Medical Device Regulations 0
B MDR Technical Structure EU Medical Device Regulations 3
D Notified Bodies - ISO 13485 & MDR Technical Files ISO 13485:2016 - Medical Device Quality Management Systems 3
L Configurable UDI mdr EU Medical Device Regulations 0
O EU MDR labels EU Medical Device Regulations 1
S Summary of safety and clinical performance and Article 120(3) of the MDR EU Medical Device Regulations 4
M MD Class I transition period MDD to MDR - changes? EU Medical Device Regulations 1
C UDI for consumable/replacement components under the MDR EU Medical Device Regulations 2
E Article 17 MDR - (Re-)Processing EU Medical Device Regulations 0
H Article 22 MDR System EU Medical Device Regulations 16
L REACH compliance with MDR EU Medical Device Regulations 4
L EU MDR Ramifications for no expiration date on labeling EU Medical Device Regulations 1
R How to obtain OBL licence under Indian MDR, 2017 Other Medical Device Related Standards 2
F MDR – Article 120 – Transitional provisions EU Medical Device Regulations 8
H MDR Article 13(c) EU Medical Device Regulations 6
Ed Panek Auditor MDR (Presub audit) finding EU Medical Device Regulations 2
M Classification of Instruments under EU MDR EU Medical Device Regulations 1
M Procedure for vigilance system according to new MDR EU Medical Device Regulations 0
M Procedure for clinical evaluation according to new MDR EU Medical Device Regulations 11
R MEDDEV 2.12-1 rev 8 (Vigilance guidelines) still applicable with the MDR implementation? EU Medical Device Regulations 1
S Determining a device category according to the MDR EU Medical Device Regulations 3

Similar threads

Top Bottom