Regulatory Open Forum

Hi All,

Certainly this is guesswork at this time as there is not a benchmark for Technical File review under the MDR- 

Could I get your thoughts on expected Technical File review times:
(I've only estimated the time period below) 

Class IIa: 3-6 months+ (closer to the higher end of 6 months) 
Class III (non-implantable, but used with embryos under non-invasive Rule 3): 9 months minimum

[We are thinking of submitting our TC during the first week of January, 2021]

Thank you.

------------------------------
April Komplin

------------------------------

​Hi April, several threads in this forum already discussed this issue. The common feeling for the moment is that throughput times currently are closer to 9 to 12 months or longer, and with implantable and class III products due to the mechanism for scrutiny even longer.
I do not expect that beginning of 2021 business will be as usual.

------------------------------
Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs
Arnhem
Netherlands
------------------------------

Original Message:
Sent: 19-Mar-2020 15:03
From: April Komplin
Subject: Technical File review times under the MDR

Hi All,

Certainly this is guesswork at this time as there is not a benchmark for Technical File review under the MDR-

Could I get your thoughts on expected Technical File review times:
(I've only estimated the time period below)

Class IIa: 3-6 months+ (closer to the higher end of 6 months)
Class III (non-implantable, but used with embryos under non-invasive Rule 3): 9 months minimum

[We are thinking of submitting our TC during the first week of January, 2021]

Thank you.

------------------------------
April Komplin

------------------------------

This message was posted by a user wishing to remain anonymous

Hi April,
I think that first of all it depends on 2 things that would very likely extend those timelines:
1. Is this your FIRST product under MDR? In which case the initial review, which includes your QMS (+1st product/product family), would most likely be much longer.
2. Who your NB is, and have you aligned with them on the timing that you plan to submit. I've heard of some NBs that due to overload may not pick up a TF for review for several months even though it was submitted to them and is just sitting there, so the timeline will depend on how long it takes your NB to even start reviewing the file. 

If you are providing estimates to your team I would err on the side of caution and estimate 9-12 months for an initial review (and even that may be a little optimistic).
(and, of course, try to align with your NB on the plans ahead of the submission to increase the chances that they will have available resources)
Original Message:
Sent: 19-Mar-2020 15:03
From: April Komplin
Subject: Technical File review times under the MDR

Hi All,

Certainly this is guesswork at this time as there is not a benchmark for Technical File review under the MDR-

Could I get your thoughts on expected Technical File review times:
(I've only estimated the time period below)

Class IIa: 3-6 months+ (closer to the higher end of 6 months)
Class III (non-implantable, but used with embryos under non-invasive Rule 3): 9 months minimum

[We are thinking of submitting our TC during the first week of January, 2021]

Thank you.

------------------------------
April Komplin

------------------------------

Definitely add a few months.  Companies are now looking at US FDA as the first to market since it is taking so long for review periods concerning CE Marking.  Until the resources are available with Notified Bodies this probably will not get any better in the short term.  Of course, this is also on medical device manufacturers side as well - the bar has been raised significantly for content of technical documentation which may not be shifting enough.  Some of the observations I have seen coming back from Notified Bodies would have been easily addressed if the time, energy, resources, and content were more substantial.  No more writing Technical Files to the MDD circa 1998, it is 2020 EU MDR - need to turn with the times.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 19-Mar-2020 21:55
From: Anonymous Member
Subject: Technical File review times under the MDR

This message was posted by a user wishing to remain anonymous

Hi April,
I think that first of all it depends on 2 things that would very likely extend those timelines:
1. Is this your FIRST product under MDR? In which case the initial review, which includes your QMS (+1st product/product family), would most likely be much longer.
2. Who your NB is, and have you aligned with them on the timing that you plan to submit. I've heard of some NBs that due to overload may not pick up a TF for review for several months even though it was submitted to them and is just sitting there, so the timeline will depend on how long it takes your NB to even start reviewing the file.

If you are providing estimates to your team I would err on the side of caution and estimate 9-12 months for an initial review (and even that may be a little optimistic).
(and, of course, try to align with your NB on the plans ahead of the submission to increase the chances that they will have available resources)
Original Message:
Sent: 19-Mar-2020 15:03
From: April Komplin
Subject: Technical File review times under the MDR

Hi All,

Certainly this is guesswork at this time as there is not a benchmark for Technical File review under the MDR-

Could I get your thoughts on expected Technical File review times:
(I've only estimated the time period below)

Class IIa: 3-6 months+ (closer to the higher end of 6 months)
Class III (non-implantable, but used with embryos under non-invasive Rule 3): 9 months minimum

[We are thinking of submitting our TC during the first week of January, 2021]

Thank you.

------------------------------
April Komplin

------------------------------

Thank you for your reply.

We are a new company manufacturing product that is yet to hit the market.

Our product is not required to be regulated by the US FDA, but we are now strongly considering 510(k) submission as it would be be a quicker path for Market Authorization Evidence into other international markets (as compared to CE Mark under the MDR).
Our product is regulated as a medical device is EU under MDR Rule 2 on non-invasive devices. 

What are the pro's and con's of using 510(k) over CE Mark for Market Authorization Evidence in other international markets?

Much appreciated-

------------------------------
April Komplin

------------------------------

Original Message:
Sent: 20-Mar-2020 09:24
From: Richard Vincins
Subject: Technical File review times under the MDR

Definitely add a few months.  Companies are now looking at US FDA as the first to market since it is taking so long for review periods concerning CE Marking.  Until the resources are available with Notified Bodies this probably will not get any better in the short term.  Of course, this is also on medical device manufacturers side as well - the bar has been raised significantly for content of technical documentation which may not be shifting enough.  Some of the observations I have seen coming back from Notified Bodies would have been easily addressed if the time, energy, resources, and content were more substantial.  No more writing Technical Files to the MDD circa 1998, it is 2020 EU MDR - need to turn with the times.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 19-Mar-2020 21:55
From: Anonymous Member
Subject: Technical File review times under the MDR

This message was posted by a user wishing to remain anonymous

Hi April,
I think that first of all it depends on 2 things that would very likely extend those timelines:
1. Is this your FIRST product under MDR? In which case the initial review, which includes your QMS (+1st product/product family), would most likely be much longer.
2. Who your NB is, and have you aligned with them on the timing that you plan to submit. I've heard of some NBs that due to overload may not pick up a TF for review for several months even though it was submitted to them and is just sitting there, so the timeline will depend on how long it takes your NB to even start reviewing the file.

If you are providing estimates to your team I would err on the side of caution and estimate 9-12 months for an initial review (and even that may be a little optimistic).
(and, of course, try to align with your NB on the plans ahead of the submission to increase the chances that they will have available resources)
Original Message:
Sent: 19-Mar-2020 15:03
From: April Komplin
Subject: Technical File review times under the MDR

Hi All,

Certainly this is guesswork at this time as there is not a benchmark for Technical File review under the MDR-

Could I get your thoughts on expected Technical File review times:
(I've only estimated the time period below)

Class IIa: 3-6 months+ (closer to the higher end of 6 months)
Class III (non-implantable, but used with embryos under non-invasive Rule 3): 9 months minimum

[We are thinking of submitting our TC during the first week of January, 2021]

Thank you.

------------------------------
April Komplin

------------------------------

My most recent information is a TUV review of a Class IIa tech file that lasted about 3 months.  I have no information on how review time was measured, i.e., what they considered to be the "start" and what they considered to be the "end" of the review.

Generally, I know exactly what a design dossier is and what the review process look like.  Under the MDD, I heard so many different descriptions of a "tech file" and the tech file review process, I gave up trying to understand what either one was "supposed to" be.  I haven't looked at the MDR for the express purpose of determining whether it has made either one clearer.  Given that there is no reference to a tech file in the MDR, as there was none in the MDD, I'm kind of doubtful.

For a Class III design dossier, as with CDRH submissions, there are a number of different timeframes in play:

Time from submission to approval/clearance/certification.
Time from submission to the start of the review.
Time from submission to receipt of results of the review.
Time from submission to resolution of all deficiencies.
Time from the start of the review to receipt of results of the review.
Time from the start of the review to resolution of all deficiencies.
Time from the start of the review to approval/clearance/certification.

Different people may describe different timeframes as the "review time."  What i consider to be the actual review time is the time between day review of the dossier actually starts and the day I receive the results of the review.  Due to lack of transparency this time is unknown, but it should be fairly short, I personally think 1-3 months. This time can be stretched a little to a lot if the reviewing organization farms out different pieces (e.g., biocomp or clinical) and doesn't manage those sub-reviews to run contingent with the main review.  Or if the reviewing organization has a bottleneck at the end of the process, so that the results of the review are available for some period of time before they are sent to the company.

Time spent in queue with CDRH is pretty short, because CDRH has legal timeframe commitments.  Time spent in queue with an NB can be interminable, because NBs do not, unless they are contractual.  Time spent resolving deficiencies cannot be reliably predicted, but whether it is CDRH or an NB, this time is determined almost entirely by the quality of the material the company submitted for review and by the company's ability to address the deficiencies, with all the real disasters driven by the latter.  So if you know the company and what the reviewers are going to be looking for, you can make a pretty good guess of how things are likely to go.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 19-Mar-2020 15:03
From: April Komplin
Subject: Technical File review times under the MDR

Hi All,

Certainly this is guesswork at this time as there is not a benchmark for Technical File review under the MDR-

Could I get your thoughts on expected Technical File review times:
(I've only estimated the time period below)

Class IIa: 3-6 months+ (closer to the higher end of 6 months)
Class III (non-implantable, but used with embryos under non-invasive Rule 3): 9 months minimum

[We are thinking of submitting our TC during the first week of January, 2021]

Thank you.

------------------------------
April Komplin

------------------------------