Has anyone undergone MDR FQA review yet?

#1
Am currently working on my submission for a Class IIa Rule 7 Instrument and wondering whether anyone had any experience yet with the MDR review?
I'm expecting a 9-12 month lead time for the assessment, providing all goes well.

I would be curious to know of your experience as a lot of comments I read are based on people's suppositions and MDCG guidance documents
 
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#2
We are currently under assessment for a class III under MDR.

Very difficult process by comparison with MDD. Submission done by end of March 2021, preliminay review in April 2021 then assessment and reports shared by end of June 2021.

I have no experience yet with class IIa
 
#3
Very difficult process by comparison with MDD. Submission done by end of March 2021, preliminary review in April 2021 then assessment and reports shared by end of June 2021.
a
Interesting, what part are you finding most difficult? I understand for Class III there is a lot more emphasis on the clinical investigation side.
 

Cybel

Involved In Discussions
#4
We are currently under assessment for a class III under MDR.

Very difficult process by comparison with MDD. Submission done by end of March 2021, preliminay review in April 2021 then assessment and reports shared by end of June 2021.

I have no experience yet with class IIa
So only 3 months in your case??

I've completed the submission in the middle of April, and they will start the review of technical document next week (class IIa).
Our NB foresees 6-8 months for a class IIa, providing all goes well.
 
#5
It is a legacy device that is why we push to accelerate.
Different part are evaluated in our case: sterilization, packaging, cleaning, biological evaluation, clinical, summary of safety and clinical performance . For each part they issue a report with non conformities. In our case despite that it is a legacy device, we received almost 200 NC to answer. The major part of them is wording issue/documentary but others are very challenging.
Tests done on your legacy device that are too old for example: rationale shall be provided to explain that they still remain applicable.
I will say without any doubt however the most challenging part is the clinical evaluation report, PSUR/PMCF, SSCP and IFU in link with clinical.

I thought I was prepared as I have experienced working mainly with class III under MDD and familiar with high level of requirement but there is no comparison possible.
I cannot imagine companies that have always dealth with class II maximum, it will be a shock. Not sure small actors will survive...
 

Mikilk

Involved In Discussions
#6
It usually depends on the availability of the specifically required reviewer, in some cases, they need more than 1 person to review the file (for example if NBOG codes) , not all NBs have the same amount of resources (TF assessors), etc, so it is always recommended to check the availabilities and timelines and choose the one that can meet your timelines, I heard of such long period of reviewing time, they are really full of work
 
#7
It is a legacy device that is why we push to accelerate.
Different part are evaluated in our case: sterilization, packaging, cleaning, biological evaluation, clinical, summary of safety and clinical performance . For each part they issue a report with non conformities. In our case despite that it is a legacy device, we received almost 200 NC to answer. The major part of them is wording issue/documentary but others are very challenging.
Tests done on your legacy device that are too old for example: rationale shall be provided to explain that they still remain applicable.
I will say without any doubt however the most challenging part is the clinical evaluation report, PSUR/PMCF, SSCP and IFU in link with clinical.

I thought I was prepared as I have experienced working mainly with class III under MDD and familiar with high level of requirement but there is no comparison possible.
I cannot imagine companies that have always dealth with class II maximum, it will be a shock. Not sure small actors will survive...
I'm glad I have Class III experience from the sounds of this. Ours is also a legacy device but I am hoping with it being from 2018, the development data will not require ass much rationalisation.
It sounds as though they do a thorough review and you get all the potential questions in one report? I have had experience with reviewers giving me NC reports in almost a "piece meal" way so this does sound a bit more positive in the aspect of getting the review completed in 3 rounds.

Can I ask, is your device something that has been on the market for 10+ years? I can imagine orthopaedic implants etc struggling with this.
 
#8
So only 3 months in your case??

I've completed the submission in the middle of April, and they will start the review of technical document next week (class IIa).
Our NB foresees 6-8 months for a class IIa, providing all goes well.
That duration sounds about right from what I have been advised as we are going via standard review. Is there anything beyond NB submission checklists (both on their website, here) and MDCG guidance documents that you used in putting together your submission package?
I know they first perform a technical document review to check they have everything they will need from you
 
#9
We have booked the slot 1 year ago as they are full. Then for the process when they receive the TF it takes less than 1 month for the preliminary review, 2 months for the assessment. Then 3 other months to answer to NC and again 1 to 2 months for final report and final answer for certification. Therefore from the TF to the final answer (certified or not) it takes between 7-8 months. And I think it is because I try to push as much as possible.
 
#10
I'm glad I have Class III experience from the sounds of this. Ours is also a legacy device but I am hoping with it being from 2018, the development data will not require ass much rationalisation.
It sounds as though they do a thorough review and you get all the potential questions in one report? I have had experience with reviewers giving me NC reports in almost a "piece meal" way so this does sound a bit more positive in the aspect of getting the review completed in 3 rounds.

Can I ask, is your device something that has been on the market for 10+ years? I can imagine orthopaedic implants etc struggling with this.

We received 8 reports, one dedicated to all NC. Implantable class III, cardiovascular, device on the market more than 10 years.
 
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