Regulatory Open Forum

It all started late one night last week, with this LinkedIn post by a sales rep with "BSI Notified Body," who had just been assigned a new sales territory:

Same job - new territory. See too many negative posts about Notified Body lack of responsiveness - so here's my challenge to industry- message me below and I'll get back to you within 24 hours.

To which I promptly replied:

Since I'm in the enviable position of not needing a response from any notified body, I can comfortably rant on behalf of those who do:

[And then I went on a fairly good rant, not at the level of KHN, but still. I'm going to decline to post it to RAPS, but I will send out the full story to my LinkedIn connections, and it will be under the posts on my LinkedIn profile.  Those of you in NB wasteland might find it somewhat cathartic. :) ]

When I got up the next morning, my comment was gone, so surprising.  However, there was another comment, "I couldn't agree with you more," which I'm pretty sure was not expressing agreement with the original post.  So I responded and said, if you're referring to my post, it seems to have disappeared, but no worries, I kept a copy and will be posting it around the internet.

Impressively, by noon I had a voice mail message from John Bis, VP Medical Devices Solutions Sales with BSI, and we had a long chat later than afternoon.  I got some information that was certainly of interest to me.  I'm not sure how much of it might be of pragmatic value to someone who is a current BSI customer, or without an MDR-designated NB altogether, but with John's permission, I will share it regardless. [Parenthetical statements below are my own musings.]

Under the MDD, BSI UK did around 500 certificates renewals per year.  [If BSI's certificates expire every 5 years…which I did not confirm with John, that would mean that "existing" clients had around 2500 devices in need of CE certificates under the MDR, plus maybe some up-classifieds.]

BSI stopped accepting applications for new MDD certificates in mid/late 2018, and started accepting applications for MDR certifications in June of last year.  They are fully booked with MDR clients until the latter part of this year; date still unknown. 

They are trying to do as many early MDD renewals prior to May 26 as possible. (I think this is a pretty good strategy, allowing them to better manage the MDR burden going forward.)  They have about 2200 MDD renewals to complete by May 26. They are also doing original MDR certifications, presumably for devices that were not a good fit for renewal, for one reason or another.  I guess we can estimate 2500-2200 = 300 of those.

[There was some confusion in terminology, as he calls a renewal at expiration a "recertification" and renewals prior to expiration "early renewals."  I think they are both renewals, just with different timeframes relevant to the original certification, so I had a little trouble trying to figure out what a "re-cert" was if it wasn't a renewal.  There was also something about an ortho 5-year renewal that I didn't understand and didn't press on.  Maybe BSI routinely does ortho devices at 5-year intervals and other devices for other timeframes?  I have worked with BSI only on ortho devices in recent memory, and those were 5-year certificates.]

His advice on non-responsiveness is to keep calling. :) [I told him I knew someone who had called every one of the then-9 MDR designated NBs a few weeks ago, and had not heard back from a single one.  He asked, but who are they calling.  If you just calling the first you find, you might want to look a little harder.  Me, if my company were in dire straits, I'd probably call every number I could find on every NB's website and message every BSI sales person on LinkedIn.  Daily. :) ]

His most important message is that they will not extend the May 26 deadline. [I don't think that message has been important for a long time now, at least not to medical device companies, since there is nothing to be done about it now.  I'm also skeptical that he is really in a position to know.  I tend to think of corporate sales personnel as a little like the White House press secretary; what they get told is not necessarily what is actually going on.]

We both agreed that there is nothing to be done now except roll with the process, which will take however long it is going to take, and that, for some medical device companies is not going to, end well, and never was, and that this is built into the regulation more than in the hands of the NBs.  We both hoped that, somewhere out the other side, will emerge better quality NBs, device companies, and devices.  We did not compare levels of optimism on this hope being realized but…he's sales, and I'm regulatory, so I think we can all figure that one out…

It all started late one night last week, with this LinkedIn post by a sales rep with "BSI Notified Body," who had just been assigned a new sales territory:

Same job - new territory. See too many negative posts about Notified Body lack of responsiveness - so here's my challenge to industry- message me below and I'll get back to you within 24 hours.

To which I promptly replied:

Since I'm in the enviable position of not needing a response from any notified body, I can comfortably rant on behalf of those who do:

[And then I went on a fairly good rant, not at the level of KHN, but still. I'm going to decline to post it to RAPS, but I will send out the full story to my LinkedIn connections, and it will be under the posts on my LinkedIn profile.  Those of you in NB wasteland might find it somewhat cathartic. :) ]

When I got up the next morning, my comment was gone, so surprising.  However, there was another comment, "I couldn't agree with you more," which I'm pretty sure was not expressing agreement with the original post.  So I responded and said, if you're referring to my post, it seems to have disappeared, but no worries, I kept a copy and will be posting it around the internet.

Impressively, by noon I had a voice mail message from John Bis, VP Medical Devices Solutions Sales with BSI, and we had a long chat later than afternoon.  I got some information that was certainly of interest to me.  I'm not sure how much of it might be of pragmatic value to someone who is a current BSI customer, or without an MDR-designated NB altogether, but with John's permission, I will share it regardless. [Parenthetical statements below are my own musings.]

Under the MDD, BSI UK did around 500 certificates renewals per year.  [If BSI's certificates expire every 5 years…which I did not confirm with John, that would mean that "existing" clients had around 2500 devices in need of CE certificates under the MDR, plus maybe some up-classifieds.]

BSI stopped accepting applications for new MDD certificates in mid/late 2018, and started accepting applications for MDR certifications in June of last year.  They are fully booked with MDR clients until the latter part of this year; date still unknown. 

They are trying to do as many early MDD renewals prior to May 26 as possible. (I think this is a pretty good strategy, allowing them to better manage the MDR burden going forward.)  They have about 2200 MDD renewals to complete by May 26. They are also doing original MDR certifications, presumably for devices that were not a good fit for renewal, for one reason or another.  I guess we can estimate 2500-2200 = 300 of those.

[There was some confusion in terminology, as he calls a renewal at expiration a "recertification" and renewals prior to expiration "early renewals."  I think they are both renewals, just with different timeframes relevant to the original certification, so I had a little trouble trying to figure out what a "re-cert" was if it wasn't a renewal.  There was also something about an ortho 5-year renewal that I didn't understand and didn't press on.  Maybe BSI routinely does ortho devices at 5-year intervals and other devices for other timeframes?  I have worked with BSI only on ortho devices in recent memory, and those were 5-year certificates.]

His advice on non-responsiveness is to keep calling. :) [I told him I knew someone who had called every one of the then-9 MDR designated NBs a few weeks ago, and had not heard back from a single one.  He asked, but who are they calling.  If you just calling the first you find, you might want to look a little harder.  Me, if my company were in dire straits, I'd probably call every number I could find on every NB's website and message every BSI sales person on LinkedIn.  Daily. :) ]

His most important message is that they will not extend the May 26 deadline. [I don't think that message has been important for a long time now, at least not to medical device companies, since there is nothing to be done about it now.  I'm also skeptical that he is really in a position to know.  I tend to think of corporate sales personnel as a little like the White House press secretary; what they get told is not necessarily what is actually going on.]

We both agreed that there is nothing to be done now except roll with the process, which will take however long it is going to take, and that, for some medical device companies is not going to, end well, and never was, and that this is built into the regulation more than in the hands of the NBs.  We both hoped that, somewhere out the other side, will emerge better quality NBs, device companies, and devices.  We did not compare levels of optimism on this hope being realized but…he's sales, and I'm regulatory, so I think we can all figure that one out…

It all started late one night last week, with this LinkedIn post by a sales rep with "BSI Notified Body," who had just been assigned a new sales territory:

Same job - new territory. See too many negative posts about Notified Body lack of responsiveness - so here's my challenge to industry- message me below and I'll get back to you within 24 hours.

To which I promptly replied:

Since I'm in the enviable position of not needing a response from any notified body, I can comfortably rant on behalf of those who do:

[And then I went on a fairly good rant, not at the level of KHN, but still. I'm going to decline to post it to RAPS, but I will send out the full story to my LinkedIn connections, and it will be under the posts on my LinkedIn profile.  Those of you in NB wasteland might find it somewhat cathartic. :) ]

When I got up the next morning, my comment was gone, so surprising.  However, there was another comment, "I couldn't agree with you more," which I'm pretty sure was not expressing agreement with the original post.  So I responded and said, if you're referring to my post, it seems to have disappeared, but no worries, I kept a copy and will be posting it around the internet.

Impressively, by noon I had a voice mail message from John Bis, VP Medical Devices Solutions Sales with BSI, and we had a long chat later than afternoon.  I got some information that was certainly of interest to me.  I'm not sure how much of it might be of pragmatic value to someone who is a current BSI customer, or without an MDR-designated NB altogether, but with John's permission, I will share it regardless. [Parenthetical statements below are my own musings.]

Under the MDD, BSI UK did around 500 certificates renewals per year.  [If BSI's certificates expire every 5 years…which I did not confirm with John, that would mean that "existing" clients had around 2500 devices in need of CE certificates under the MDR, plus maybe some up-classifieds.]

BSI stopped accepting applications for new MDD certificates in mid/late 2018, and started accepting applications for MDR certifications in June of last year.  They are fully booked with MDR clients until the latter part of this year; date still unknown. 

They are trying to do as many early MDD renewals prior to May 26 as possible. (I think this is a pretty good strategy, allowing them to better manage the MDR burden going forward.)  They have about 2200 MDD renewals to complete by May 26. They are also doing original MDR certifications, presumably for devices that were not a good fit for renewal, for one reason or another.  I guess we can estimate 2500-2200 = 300 of those.

[There was some confusion in terminology, as he calls a renewal at expiration a "recertification" and renewals prior to expiration "early renewals."  I think they are both renewals, just with different timeframes relevant to the original certification, so I had a little trouble trying to figure out what a "re-cert" was if it wasn't a renewal.  There was also something about an ortho 5-year renewal that I didn't understand and didn't press on.  Maybe BSI routinely does ortho devices at 5-year intervals and other devices for other timeframes?  I have worked with BSI only on ortho devices in recent memory, and those were 5-year certificates.]

His advice on non-responsiveness is to keep calling. :) [I told him I knew someone who had called every one of the then-9 MDR designated NBs a few weeks ago, and had not heard back from a single one.  He asked, but who are they calling.  If you just calling the first you find, you might want to look a little harder.  Me, if my company were in dire straits, I'd probably call every number I could find on every NB's website and message every BSI sales person on LinkedIn.  Daily. :) ]

His most important message is that they will not extend the May 26 deadline. [I don't think that message has been important for a long time now, at least not to medical device companies, since there is nothing to be done about it now.  I'm also skeptical that he is really in a position to know.  I tend to think of corporate sales personnel as a little like the White House press secretary; what they get told is not necessarily what is actually going on.]

We both agreed that there is nothing to be done now except roll with the process, which will take however long it is going to take, and that, for some medical device companies is not going to, end well, and never was, and that this is built into the regulation more than in the hands of the NBs.  We both hoped that, somewhere out the other side, will emerge better quality NBs, device companies, and devices.  We did not compare levels of optimism on this hope being realized but…he's sales, and I'm regulatory, so I think we can all figure that one out…

It all started late one night last week, with this LinkedIn post by a sales rep with "BSI Notified Body," who had just been assigned a new sales territory:

Same job - new territory. See too many negative posts about Notified Body lack of responsiveness - so here's my challenge to industry- message me below and I'll get back to you within 24 hours.

To which I promptly replied:

Since I'm in the enviable position of not needing a response from any notified body, I can comfortably rant on behalf of those who do:

[And then I went on a fairly good rant, not at the level of KHN, but still. I'm going to decline to post it to RAPS, but I will send out the full story to my LinkedIn connections, and it will be under the posts on my LinkedIn profile.  Those of you in NB wasteland might find it somewhat cathartic. :) ]

When I got up the next morning, my comment was gone, so surprising.  However, there was another comment, "I couldn't agree with you more," which I'm pretty sure was not expressing agreement with the original post.  So I responded and said, if you're referring to my post, it seems to have disappeared, but no worries, I kept a copy and will be posting it around the internet.

Impressively, by noon I had a voice mail message from John Bis, VP Medical Devices Solutions Sales with BSI, and we had a long chat later than afternoon.  I got some information that was certainly of interest to me.  I'm not sure how much of it might be of pragmatic value to someone who is a current BSI customer, or without an MDR-designated NB altogether, but with John's permission, I will share it regardless. [Parenthetical statements below are my own musings.]

Under the MDD, BSI UK did around 500 certificates renewals per year.  [If BSI's certificates expire every 5 years…which I did not confirm with John, that would mean that "existing" clients had around 2500 devices in need of CE certificates under the MDR, plus maybe some up-classifieds.]

BSI stopped accepting applications for new MDD certificates in mid/late 2018, and started accepting applications for MDR certifications in June of last year.  They are fully booked with MDR clients until the latter part of this year; date still unknown. 

They are trying to do as many early MDD renewals prior to May 26 as possible. (I think this is a pretty good strategy, allowing them to better manage the MDR burden going forward.)  They have about 2200 MDD renewals to complete by May 26. They are also doing original MDR certifications, presumably for devices that were not a good fit for renewal, for one reason or another.  I guess we can estimate 2500-2200 = 300 of those.

[There was some confusion in terminology, as he calls a renewal at expiration a "recertification" and renewals prior to expiration "early renewals."  I think they are both renewals, just with different timeframes relevant to the original certification, so I had a little trouble trying to figure out what a "re-cert" was if it wasn't a renewal.  There was also something about an ortho 5-year renewal that I didn't understand and didn't press on.  Maybe BSI routinely does ortho devices at 5-year intervals and other devices for other timeframes?  I have worked with BSI only on ortho devices in recent memory, and those were 5-year certificates.]

His advice on non-responsiveness is to keep calling. :) [I told him I knew someone who had called every one of the then-9 MDR designated NBs a few weeks ago, and had not heard back from a single one.  He asked, but who are they calling.  If you just calling the first you find, you might want to look a little harder.  Me, if my company were in dire straits, I'd probably call every number I could find on every NB's website and message every BSI sales person on LinkedIn.  Daily. :) ]

His most important message is that they will not extend the May 26 deadline. [I don't think that message has been important for a long time now, at least not to medical device companies, since there is nothing to be done about it now.  I'm also skeptical that he is really in a position to know.  I tend to think of corporate sales personnel as a little like the White House press secretary; what they get told is not necessarily what is actually going on.]

We both agreed that there is nothing to be done now except roll with the process, which will take however long it is going to take, and that, for some medical device companies is not going to, end well, and never was, and that this is built into the regulation more than in the hands of the NBs.  We both hoped that, somewhere out the other side, will emerge better quality NBs, device companies, and devices.  We did not compare levels of optimism on this hope being realized but…he's sales, and I'm regulatory, so I think we can all figure that one out…

It all started late one night last week, with this LinkedIn post by a sales rep with "BSI Notified Body," who had just been assigned a new sales territory:

Same job - new territory. See too many negative posts about Notified Body lack of responsiveness - so here's my challenge to industry- message me below and I'll get back to you within 24 hours.

To which I promptly replied:

Since I'm in the enviable position of not needing a response from any notified body, I can comfortably rant on behalf of those who do:

[And then I went on a fairly good rant, not at the level of KHN, but still. I'm going to decline to post it to RAPS, but I will send out the full story to my LinkedIn connections, and it will be under the posts on my LinkedIn profile.  Those of you in NB wasteland might find it somewhat cathartic. :) ]

When I got up the next morning, my comment was gone, so surprising.  However, there was another comment, "I couldn't agree with you more," which I'm pretty sure was not expressing agreement with the original post.  So I responded and said, if you're referring to my post, it seems to have disappeared, but no worries, I kept a copy and will be posting it around the internet.

Impressively, by noon I had a voice mail message from John Bis, VP Medical Devices Solutions Sales with BSI, and we had a long chat later than afternoon.  I got some information that was certainly of interest to me.  I'm not sure how much of it might be of pragmatic value to someone who is a current BSI customer, or without an MDR-designated NB altogether, but with John's permission, I will share it regardless. [Parenthetical statements below are my own musings.]

Under the MDD, BSI UK did around 500 certificates renewals per year.  [If BSI's certificates expire every 5 years…which I did not confirm with John, that would mean that "existing" clients had around 2500 devices in need of CE certificates under the MDR, plus maybe some up-classifieds.]

BSI stopped accepting applications for new MDD certificates in mid/late 2018, and started accepting applications for MDR certifications in June of last year.  They are fully booked with MDR clients until the latter part of this year; date still unknown. 

They are trying to do as many early MDD renewals prior to May 26 as possible. (I think this is a pretty good strategy, allowing them to better manage the MDR burden going forward.)  They have about 2200 MDD renewals to complete by May 26. They are also doing original MDR certifications, presumably for devices that were not a good fit for renewal, for one reason or another.  I guess we can estimate 2500-2200 = 300 of those.

[There was some confusion in terminology, as he calls a renewal at expiration a "recertification" and renewals prior to expiration "early renewals."  I think they are both renewals, just with different timeframes relevant to the original certification, so I had a little trouble trying to figure out what a "re-cert" was if it wasn't a renewal.  There was also something about an ortho 5-year renewal that I didn't understand and didn't press on.  Maybe BSI routinely does ortho devices at 5-year intervals and other devices for other timeframes?  I have worked with BSI only on ortho devices in recent memory, and those were 5-year certificates.]

His advice on non-responsiveness is to keep calling. :) [I told him I knew someone who had called every one of the then-9 MDR designated NBs a few weeks ago, and had not heard back from a single one.  He asked, but who are they calling.  If you just calling the first you find, you might want to look a little harder.  Me, if my company were in dire straits, I'd probably call every number I could find on every NB's website and message every BSI sales person on LinkedIn.  Daily. :) ]

His most important message is that they will not extend the May 26 deadline. [I don't think that message has been important for a long time now, at least not to medical device companies, since there is nothing to be done about it now.  I'm also skeptical that he is really in a position to know.  I tend to think of corporate sales personnel as a little like the White House press secretary; what they get told is not necessarily what is actually going on.]

We both agreed that there is nothing to be done now except roll with the process, which will take however long it is going to take, and that, for some medical device companies is not going to, end well, and never was, and that this is built into the regulation more than in the hands of the NBs.  We both hoped that, somewhere out the other side, will emerge better quality NBs, device companies, and devices.  We did not compare levels of optimism on this hope being realized but…he's sales, and I'm regulatory, so I think we can all figure that one out…