MDR Literature search timeline

MDRexpert

Involved In Discussions
Hello Folks,

Is there any article or white paper that explains on appropriate date range for clinical data to justify equivalence under MDR?
Our concern is we have just 5 years of data and we are going to need to turn around in a few short months and do a 10+ years to satisfy MDR.
Can someone suggest articles or white papers that explains this to refute our concern?
Please provide your personal experience on how you justify the time period chosen for literature searches? How do you propose we justify 5 years for MDR? Do you feel this is appropriate? - our device is a class IIa and has been on the market for a long time, its well understood, etc.


Any suggestion/advise/information is helpful. Thanks!
 

SKM.Sunil

Involved In Discussions
I would rather say you have a misconception that more the year's data, you cover in literature search more you will satisfy the requirement.

Literature search/inclusion carries a significance, why they are referred in the guidelines/rules.
on the basis of requirement, literature search are for 2 requirements
1. to technological support D&D (product development, proof of concept, manufacturing, risks etc..) - contains all available marketed equivalent device data/ sometimes may not be any device itself
2. to clinical support D&D (Clinical evaluation & risk etc..) - only contains claimed equivalent device data and/or self data

- You must always present the literature appropriately at required sections (e.g. clinical evaluation file must presented with clinical literature not that of non-clinical or non-equivalent device data).

There are more to it....you must aware of the processes, before just expanding your search

hence I would say...stick to quality data, rather quantity, which may backfire you.
 

Biomedical_engeener

Starting to get Involved
Is clinical evaluation needed if device is already place on the market under MDD for a long time?
What is the difference between Clinical evaluation and PMCF ?
Our device is a custom made device, so we've been self-certificated before.
 

SKM.Sunil

Involved In Discussions
Is clinical evaluation needed if device is already place on the market under MDD for a long time?
What is the difference between Clinical evaluation and PMCF ?
Our device is a custom made device, so we've been self-certificated before.


Is clinical evaluation needed if device is already place on the market under MDD for a long time?
Clinical Evaluation is part of continuous update of the device clinical experience from market - YES it is needed

What is the difference between Clinical evaluation and PMCF ?
1st You need to understand there is a difference between CLINICAL EVALUATION & CLINICAL EVALUATION REPORT.

Clinical Evaluation is part of your design verification - hence it is part of design development (file), it may or may not include your device experience from market (if you are putting your device 1st time in market).

CER- is summary of Clinical evaluation, clinical experience (PMCF), PMS, Equivalent device experience, Risk Management etc..

PMCF- is procedure laid to collect the post market clinical data from the market. ( your own device, of similar device on market, residual risks, reports of vigilance system etc..). PMCF need to be updated for every upcoming year, that how you are going to collect data for your next clinical evaluation/report.

<<These all explain in a short, there are more to it>>>
 

MDRexpert

Involved In Discussions
Following previous question: What is the difference between Clinical Evaluation Report and PSUR ( Periodic Safety Update Report ) ?
PSUR is an update that you provide to notified body.
A CER is an extensive report that summarizes all the aspects of the device providing the safety and the risk factors. This needs to be updated depending on the device classification and any changes in the product that may trigger an update to the CER.
While PSUR is an update to the notified body specifically describing that you've considered all the risk factors into your product. This added update is to ensure that the ongoing considerations of the risk on the device is accomplished and a quick way for notified bodies to stay on top.
 

SKM.Sunil

Involved In Discussions
Following previous question: What is the difference between Clinical Evaluation Report and PSUR ( Periodic Safety Update Report ) ?

CER- compilation of Clinical experience from market (as I said in my previous answer)

PSUR - Is now a requirement under EUMDR for Class-IIa,IIb,III in-place of a PMS report. here you will be summarizing,
Summary of results and conclusions resulting from PMS Plan including: CAPA taken, PMCF findings, Sales, Number of patient (estimate), Usage frequency (if applicable), Patient characteristics, Vigilance, market surveillance, trend and trend analysis etc..

Refer below thread for more information, I have added a template (attachment) briefing about the content of a PSUR
EU MDR and PSUR (Periodic Safety Update Report)
 

MDRexpert

Involved In Discussions
Hello again,

One more question - When updating the CER, we are just focusing mostly on the extension tube since that's what has been added to the product family which initiates this update to the Tech file as well as the CER.
Now my question is that do we have to include the previous CER data again on the connector since our initial CER already covers that and it would be redundant to have that information in the update. Also, the literature search gap analysis will be for a year and that will not provide us any new information to add.

My understanding is that we are just updating the extension tube to our product family, the point of this CER update would be to consider safety and risk factors of the extension to the intended use. Is that correct?

Any suggestion/advise/information is appreciated. Thanks!
 

MDRexpert

Involved In Discussions
If we update our current CER - under the connectors we don't have any new information on literature search. Do we just include previous CER literature search in addition to the any new extension tube search?
Please advice?
 
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