Clinical evaluation interface with the risk management process

Mike Towers

Involved In Discussions
#1
Hello everyone,
I have a CE Marking Audit according to the MDR soon, within the documentation they request I have to prepare "Procedure for clinical validation", within which there must be a section that deals with the following:
- The interface with the risk management process,
 
Elsmar Forum Sponsor

Mike Towers

Involved In Discussions
#3
Thank you for your response.
My question was about how the Clinical Evaluation and Risk Management processes feed back.
That is, how would a variation in the Global Residual Risk Assessment affect the Clinical Assessment, for example.
 
#4
What do you mean by "variation"? If there is a new, previously unidentified risk, regardless of the source, it could affect the benefit-risk analysis, which in turn could mean that the clinical study should be on hold or terminated. Can you ask your question in a more specific way?
 

Junn1992

Quite Involved in Discussions
#5
You just need to show the connection between your risk management plan and the CER. Eg:

1. Design phase: Risk Management Version 1
2. After pre-clinical testing: Risk Management version 2 (some new risks identified)
3. During clinical testing: Risk management version 3 (some usability issues identified)
4. Post clinical testing and final evaluation for clinical evaluation report: Risk management version 4
================
5. Post market: Risk management version 5 (issues detected post market) etc. etc.
 

Mike Towers

Involved In Discussions
#6
What do you mean by "variation"? If there is a new, previously unidentified risk, regardless of the source, it could affect the benefit-risk analysis, which in turn could mean that the clinical study should be on hold or terminated. Can you ask your question in a more specific way?
Exactly what the Auditor asked for is:
Your quality system must include procedures and documentation related to device clinical evaluation which adequately address:
- the interface with the risk management process
 

Mike Towers

Involved In Discussions
#7
Thanks for your quickly reply!
And once the Clinical Evaluation Report and the Risk Management Report have been carried out, what would be the input that would cause the clinical evaluation report to have to be modified?
 

Junn1992

Quite Involved in Discussions
#8
And once the Clinical Evaluation Report and the Risk Management Report have been carried out, what would be the input that would cause the clinical evaluation report to have to be modified?
Under the MDR, there are many things that could possibly cause an update to the CER, but I think you are specifically asking about Risk Management.

Typically, whenever new risks are identified, the risk management file/section gets updated. And because the risks are updated, you are then required to re-evaluate the benefit-risk determination of the device overall, which translates into an update of the CER.
 

Mike Towers

Involved In Discussions
#9
Thanks @Junn1992
I wanted to know your opinion, the CER will only be updated in case the new risk detected changes the Benefit/Risk ratio, is that correct?
In other words, if control measures can be implemented for the detected risk, so that its severity and frequency can be considered as acceptable, I understand that it would not be necessary to update the CER, since the benefit/risk ratio did not change, is that so?

Thank you,
 

Junn1992

Quite Involved in Discussions
#10
Thanks @Junn1992
I wanted to know your opinion, the CER will only be updated in case the new risk detected changes the Benefit/Risk ratio, is that correct?
In other words, if control measures can be implemented for the detected risk, so that its severity and frequency can be considered as acceptable, I understand that it would not be necessary to update the CER, since the benefit/risk ratio did not change, is that so?

Thank you,
The CER would still need to be updated since the information contained in risk management has changed, and control measures have been implemented. In this scenario, implementing a control measure might also result in updating your IFU's, which also affects the technical file.
 
Thread starter Similar threads Forum Replies Date
M Clinical evaluation process of FDA and MDR Medical Device and FDA Regulations and Standards News 2
B Clinical evaluation according to equivalence with another device EU Medical Device Regulations 4
N Unused proceses (Clinical Evaluation) ISO 13485:2016 - Medical Device Quality Management Systems 4
M An introductory guide to medical device Clinical Evaluation & Clinical Evaluation Reports (CER) EU Medical Device Regulations 0
H MDR clinical evaluation EU Medical Device Regulations 0
S Impact to clinical evaluation of MDCG2022-14 EU Medical Device Regulations 2
R Clinical evaluation for instrument of a navigation system EU Medical Device Regulations 1
A Loss of certification because of outdated information in the Clinical Evaluation Report CE Marking (Conformité Européene) / CB Scheme 8
R MDR Clinical Evaluation Plan EU Medical Device Regulations 6
R Clinical Evaluation - state of the art literature search EU Medical Device Regulations 5
J Clinical Evaluation For Instruments - Class I, Class Ir, Class Im, and Class IIa - EU MDR EU Medical Device Regulations 4
L Clinical Evaluation MDR EU Medical Device Regulations 15
I Clinical evaluation for legacy device EU Medical Device Regulations 16
M Clinical evaluation report training EU Medical Device Regulations 3
K Continue to do clinical evaluation? or transfer to RA? or focus on clinical studies as MA? Career and Occupation Discussions 1
O CLINICAL EVALUATION - VACCUM PLANTS Other Medical Device Related Standards 4
E DESIGN VALIDATION, USABILITY AND CLINICAL EVALUATION request Medical Device and FDA Regulations and Standards News 0
S Clinical Evaluation of equivalent device EU Medical Device Regulations 7
L Clinical evaluation plan EU Medical Device Regulations 17
M Procedure for clinical evaluation according to new MDR EU Medical Device Regulations 11
shimonv Clinical evaluation report for class I device EU Medical Device Regulations 18
P GSPRs / Clinical Evaluation EU Medical Device Regulations 3
silentmonkey Overall Benefit/Risk Analysis - Risk Management VS Clinical Evaluation ISO 14971 - Medical Device Risk Management 3
Q Summative Usability Evaluation Testing: prior or during Clinical Investigation? Human Factors and Ergonomics in Engineering 10
S Regular updates of clinical evaluation report EU Medical Device Regulations 6
M Clinical Evaluation Benchmark vs. Equivalent EU Medical Device Regulations 2
S Australia TGA Clinical Evaluation Report (CER) Other Medical Device Regulations World-Wide 0
B Clinical Evaluation Expert Panels - MDR EU Medical Device Regulations 1
T Clinical evaluation of a new medical device EU Medical Device Regulations 0
dgrainger Informational MDCG 2020:13 - Clinical evaluation assessment report template EU Medical Device Regulations 0
S A clinical performance evaluation study with an IVD product as Investagional Use product - Clinical Monitor requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R Clinical evaluation without clinical data - MDR Article 61(10) EU Medical Device Regulations 11
M Clinical Evaluation Plan vs. PMCF Plan EU Medical Device Regulations 33
M Can someone share a scrubbed version of Clinical Evaluation Plan (CEP) EU Medical Device Regulations 8
S EU MDR Annex XIV - Clinical Evaluation Plan - What do these methods mean? EU Medical Device Regulations 16
S Clinical Evaluation - Is this an ISO 13485:2016 requirement? ISO 13485:2016 - Medical Device Quality Management Systems 4
M Informational How to perform a clinical evaluation of medical devices – Part 2 – Level of clinical evidence and what sufficient clinical evidence means Medical Device and FDA Regulations and Standards News 9
M Informational How to perform a clinical evaluation of medical devices – Part 1 – Overview and sample of activities Medical Device and FDA Regulations and Standards News 0
T EU MDR Article 61- Clinical Evaluation EU Medical Device Regulations 2
pashah Looking for Clinical Evaluation SOP acc. MEDDEV and EU MDR Other Medical Device Related Standards 1
D Clinical Evaluation Report - Consultant Recommendations Consultants and Consulting 9
M CER (Clinical Evaluation Reports) updates - Product Codes EU Medical Device Regulations 2
A Medical device CER (clinical evaluation report) training/seminar services EU Medical Device Regulations 2
M Informational IMDRF – Proposed update to Clinical Evaluation documents Medical Device and FDA Regulations and Standards News 0
M Informational MDCG 2019-3 Interpretation of Article 54(2)b – Pre- market clinical evaluation consultation procedure with the involvement of expert panels Medical Device and FDA Regulations and Standards News 0
TheMightyWife Clinical Evaluation MEDDEV 2.7.1 Rev 4 demonstration of equivalence EU Medical Device Regulations 6
C How frequent to conduct Clinical / Performance Evaluation? CE Marking (Conformité Européene) / CB Scheme 4
H Addressing of Undesirable side-effects, harms, risks and side-effects in clinical evaluation report (CER) EU Medical Device Regulations 12
W Literature used in the clinical evaluation ISO 13485:2016 - Medical Device Quality Management Systems 4
S Medical device CER (clinical evaluation report) according to MDR EU Medical Device Regulations 24

Similar threads

Top Bottom