Regulatory Open Forum

Hi, all,
Has anyone yet submitted technical documentation to a notified body for MDR certification? We use BSI, and they provide per day cost but haven't provided an estimate on the duration of a standard versus dedicated audit. Of course that can be quite variable depending on the types of questions that come during the audit. Hoping someone has some real experience.
Thanks,
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Hi Jackie:
Good question, but it will depend on the risk classification of the device, the complexity of the device or the product system, the number of different "subject matter experts" they need (e.g. software, microbiology, composite materials etc) each will need additional time to get up to speed on the whole system. ... then of course the number of questions and the speed and completeness of your response. Taking that into account for a medium risk stand-alone device anywhere between three days and three weeks. Do note, not all "experts" are the same cost, you have to delve into the small print to find this and getting charged several thousand for a day of a clinical expert can be a nasty shock to the budget. Sorry its a bit lake taking your car into your trusted local repair shop and saying do what it takes! - you hope for the best but have to be prepared for the worst!

Good luck!

Neil

------------------------------
Neil Armstrong FRAPS
CEO MeddiQuest Limited
Peterborough
United Kingdom
------------------------------

Original Message:
Sent: 23-Jun-2021 16:45
From: Jackie Jaskula
Subject: Number of days for MDR tech document review

Hi, all,
Has anyone yet submitted technical documentation to a notified body for MDR certification? We use BSI, and they provide per day cost but haven't provided an estimate on the duration of a standard versus dedicated audit. Of course that can be quite variable depending on the types of questions that come during the audit. Hoping someone has some real experience.
Thanks,
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Original Message:
Sent: 6/24/2021 5:18:00 AM
From: Neil Armstrong
Subject: RE: Number of days for MDR tech document review

Hi Jackie:
Good question, but it will depend on the risk classification of the device, the complexity of the device or the product system, the number of different "subject matter experts" they need (e.g. software, microbiology, composite materials etc) each will need additional time to get up to speed on the whole system. ... then of course the number of questions and the speed and completeness of your response. Taking that into account for a medium risk stand-alone device anywhere between three days and three weeks. Do note, not all "experts" are the same cost, you have to delve into the small print to find this and getting charged several thousand for a day of a clinical expert can be a nasty shock to the budget. Sorry its a bit lake taking your car into your trusted local repair shop and saying do what it takes! - you hope for the best but have to be prepared for the worst!

Good luck!

Neil

------------------------------
Neil Armstrong FRAPS
CEO MeddiQuest Limited
Peterborough
United Kingdom
------------------------------

Original Message:
Sent: 23-Jun-2021 16:45
From: Jackie Jaskula
Subject: Number of days for MDR tech document review

Hi, all,
Has anyone yet submitted technical documentation to a notified body for MDR certification? We use BSI, and they provide per day cost but haven't provided an estimate on the duration of a standard versus dedicated audit. Of course that can be quite variable depending on the types of questions that come during the audit. Hoping someone has some real experience.
Thanks,
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Hi Jackie,
based on your portfolio, I am assuming you will submit for class IIa and IIb implantables, both WET and non-WET (Ir, Is not going the same route so not mentioning it here). Not sure if any of your devices were up classified to class III but Class III timelines are still comparable to class IIb non-WET. I have worked with BSI Ortho-Dental branch on MDR submissions. For class IIa, if file is complete according to the BSI completeness checklist and the manufacturer responds in a timely manner, the review can be done in as little as 3 months from the day it was picked for the administrative review. For IIb implantables, for first couple files I would plan for 9 months. Then, if feedback from first couple files is applied to the rest of submissions, timeline may be shorten but will still plan minimum 6 months. This is for a dedicated review. About 70% MDR submissions are requesting dedicated review with BSI and I strongly recommend a dedicated route for the first file. Otherwise, you will wait a while to be put on the schedule and won't be able to apply feedback form BSI that you receive for your first fil to other files you will be working on. Please keep in mind that these estimated timelines are from the day when BSI does the administrative review of the file. First, the proposal needs to be signed and your file needs to be put on the schedule. Even though BSI is great and responsive, it can take between 2-8 weeks (from my experience) since the volume of files they receive is very high. 
BSI provides good guidance and tools so following their completeness checklist for the submissions can really shorten the review time. 
Hope it helps.
Olga

------------------------------
Olga Lewis RAC
Regulatory Affairs Consultant
Broomfield CO
United States
------------------------------

Original Message:
Sent: 23-Jun-2021 16:45
From: Jackie Jaskula
Subject: Number of days for MDR tech document review

Hi, all,
Has anyone yet submitted technical documentation to a notified body for MDR certification? We use BSI, and they provide per day cost but haven't provided an estimate on the duration of a standard versus dedicated audit. Of course that can be quite variable depending on the types of questions that come during the audit. Hoping someone has some real experience.
Thanks,
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Original Message:
Sent: 6/24/2021 8:33:00 AM
From: Olga Lewis
Subject: RE: Number of days for MDR tech document review

Hi Jackie,
based on your portfolio, I am assuming you will submit for class IIa and IIb implantables, both WET and non-WET (Ir, Is not going the same route so not mentioning it here). Not sure if any of your devices were up classified to class III but Class III timelines are still comparable to class IIb non-WET. I have worked with BSI Ortho-Dental branch on MDR submissions. For class IIa, if file is complete according to the BSI completeness checklist and the manufacturer responds in a timely manner, the review can be done in as little as 3 months from the day it was picked for the administrative review. For IIb implantables, for first couple files I would plan for 9 months. Then, if feedback from first couple files is applied to the rest of submissions, timeline may be shorten but will still plan minimum 6 months. This is for a dedicated review. About 70% MDR submissions are requesting dedicated review with BSI and I strongly recommend a dedicated route for the first file. Otherwise, you will wait a while to be put on the schedule and won't be able to apply feedback form BSI that you receive for your first fil to other files you will be working on. Please keep in mind that these estimated timelines are from the day when BSI does the administrative review of the file. First, the proposal needs to be signed and your file needs to be put on the schedule. Even though BSI is great and responsive, it can take between 2-8 weeks (from my experience) since the volume of files they receive is very high. 
BSI provides good guidance and tools so following their completeness checklist for the submissions can really shorten the review time. 
Hope it helps.
Olga

------------------------------
Olga Lewis RAC
Regulatory Affairs Consultant
Broomfield CO
United States
------------------------------

Original Message:
Sent: 23-Jun-2021 16:45
From: Jackie Jaskula
Subject: Number of days for MDR tech document review

Hi, all,
Has anyone yet submitted technical documentation to a notified body for MDR certification? We use BSI, and they provide per day cost but haven't provided an estimate on the duration of a standard versus dedicated audit. Of course that can be quite variable depending on the types of questions that come during the audit. Hoping someone has some real experience.
Thanks,
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Hi Jackie;

Our quote from BSI for the EU MDR QMS audit plus CE assessment audits for 4 Class IIa and one Class IIb devices was approximately $176,000 USD.

------------------------------
Shelley Looby
Director, Regulatory Affairs & Quality Assurance
Kansas City MO
United States
------------------------------

Original Message:
Sent: 24-Jun-2021 09:37
From: Jackie Jaskula
Subject: Number of days for MDR tech document review

Olga,

Thank you so much for your very thorough response, especially the advice on using the dedicated route. This will greatly facilitate our application process and reviews.

Jackie

Original Message:
Sent: 6/24/2021 8:33:00 AM
From: Olga Lewis
Subject: RE: Number of days for MDR tech document review

Hi Jackie,
based on your portfolio, I am assuming you will submit for class IIa and IIb implantables, both WET and non-WET (Ir, Is not going the same route so not mentioning it here). Not sure if any of your devices were up classified to class III but Class III timelines are still comparable to class IIb non-WET. I have worked with BSI Ortho-Dental branch on MDR submissions. For class IIa, if file is complete according to the BSI completeness checklist and the manufacturer responds in a timely manner, the review can be done in as little as 3 months from the day it was picked for the administrative review. For IIb implantables, for first couple files I would plan for 9 months. Then, if feedback from first couple files is applied to the rest of submissions, timeline may be shorten but will still plan minimum 6 months. This is for a dedicated review. About 70% MDR submissions are requesting dedicated review with BSI and I strongly recommend a dedicated route for the first file. Otherwise, you will wait a while to be put on the schedule and won't be able to apply feedback form BSI that you receive for your first fil to other files you will be working on. Please keep in mind that these estimated timelines are from the day when BSI does the administrative review of the file. First, the proposal needs to be signed and your file needs to be put on the schedule. Even though BSI is great and responsive, it can take between 2-8 weeks (from my experience) since the volume of files they receive is very high.
BSI provides good guidance and tools so following their completeness checklist for the submissions can really shorten the review time.
Hope it helps.
Olga

------------------------------
Olga Lewis RAC
Regulatory Affairs Consultant
Broomfield CO
United States

Original Message:
Sent: 23-Jun-2021 16:45
From: Jackie Jaskula
Subject: Number of days for MDR tech document review

Hi, all,
Has anyone yet submitted technical documentation to a notified body for MDR certification? We use BSI, and they provide per day cost but haven't provided an estimate on the duration of a standard versus dedicated audit. Of course that can be quite variable depending on the types of questions that come during the audit. Hoping someone has some real experience.
Thanks,
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Thanks for sharing, Shelley!

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Original Message:
Sent: 25-Jun-2021 09:54
From: Shelley Looby
Subject: Number of days for MDR tech document review

Hi Jackie;

Our quote from BSI for the EU MDR QMS audit plus CE assessment audits for 4 Class IIa and one Class IIb devices was approximately $176,000 USD.

------------------------------
Shelley Looby
Director, Regulatory Affairs & Quality Assurance
Kansas City MO
United States

Original Message:
Sent: 24-Jun-2021 09:37
From: Jackie Jaskula
Subject: Number of days for MDR tech document review

Olga,

Thank you so much for your very thorough response, especially the advice on using the dedicated route. This will greatly facilitate our application process and reviews.

Jackie

Original Message:
Sent: 6/24/2021 8:33:00 AM
From: Olga Lewis
Subject: RE: Number of days for MDR tech document review

Hi Jackie,
based on your portfolio, I am assuming you will submit for class IIa and IIb implantables, both WET and non-WET (Ir, Is not going the same route so not mentioning it here). Not sure if any of your devices were up classified to class III but Class III timelines are still comparable to class IIb non-WET. I have worked with BSI Ortho-Dental branch on MDR submissions. For class IIa, if file is complete according to the BSI completeness checklist and the manufacturer responds in a timely manner, the review can be done in as little as 3 months from the day it was picked for the administrative review. For IIb implantables, for first couple files I would plan for 9 months. Then, if feedback from first couple files is applied to the rest of submissions, timeline may be shorten but will still plan minimum 6 months. This is for a dedicated review. About 70% MDR submissions are requesting dedicated review with BSI and I strongly recommend a dedicated route for the first file. Otherwise, you will wait a while to be put on the schedule and won't be able to apply feedback form BSI that you receive for your first fil to other files you will be working on. Please keep in mind that these estimated timelines are from the day when BSI does the administrative review of the file. First, the proposal needs to be signed and your file needs to be put on the schedule. Even though BSI is great and responsive, it can take between 2-8 weeks (from my experience) since the volume of files they receive is very high.
BSI provides good guidance and tools so following their completeness checklist for the submissions can really shorten the review time.
Hope it helps.
Olga

------------------------------
Olga Lewis RAC
Regulatory Affairs Consultant
Broomfield CO
United States

Original Message:
Sent: 23-Jun-2021 16:45
From: Jackie Jaskula
Subject: Number of days for MDR tech document review

Hi, all,
Has anyone yet submitted technical documentation to a notified body for MDR certification? We use BSI, and they provide per day cost but haven't provided an estimate on the duration of a standard versus dedicated audit. Of course that can be quite variable depending on the types of questions that come during the audit. Hoping someone has some real experience.
Thanks,
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Shelley, do you mind sharing a little more? This seems like the cost for a standard audit as opposed to dedicated. Is that right? Are your 4 Class IIa systems grouped together and sampled or are they all audited independently. 
Thanks again and have a great weekend!
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Original Message:
Sent: 25-Jun-2021 09:54
From: Shelley Looby
Subject: Number of days for MDR tech document review

Hi Jackie;

Our quote from BSI for the EU MDR QMS audit plus CE assessment audits for 4 Class IIa and one Class IIb devices was approximately $176,000 USD.

------------------------------
Shelley Looby
Director, Regulatory Affairs & Quality Assurance
Kansas City MO
United States

Original Message:
Sent: 24-Jun-2021 09:37
From: Jackie Jaskula
Subject: Number of days for MDR tech document review

Olga,

Thank you so much for your very thorough response, especially the advice on using the dedicated route. This will greatly facilitate our application process and reviews.

Jackie

Original Message:
Sent: 6/24/2021 8:33:00 AM
From: Olga Lewis
Subject: RE: Number of days for MDR tech document review

Hi Jackie,
based on your portfolio, I am assuming you will submit for class IIa and IIb implantables, both WET and non-WET (Ir, Is not going the same route so not mentioning it here). Not sure if any of your devices were up classified to class III but Class III timelines are still comparable to class IIb non-WET. I have worked with BSI Ortho-Dental branch on MDR submissions. For class IIa, if file is complete according to the BSI completeness checklist and the manufacturer responds in a timely manner, the review can be done in as little as 3 months from the day it was picked for the administrative review. For IIb implantables, for first couple files I would plan for 9 months. Then, if feedback from first couple files is applied to the rest of submissions, timeline may be shorten but will still plan minimum 6 months. This is for a dedicated review. About 70% MDR submissions are requesting dedicated review with BSI and I strongly recommend a dedicated route for the first file. Otherwise, you will wait a while to be put on the schedule and won't be able to apply feedback form BSI that you receive for your first fil to other files you will be working on. Please keep in mind that these estimated timelines are from the day when BSI does the administrative review of the file. First, the proposal needs to be signed and your file needs to be put on the schedule. Even though BSI is great and responsive, it can take between 2-8 weeks (from my experience) since the volume of files they receive is very high.
BSI provides good guidance and tools so following their completeness checklist for the submissions can really shorten the review time.
Hope it helps.
Olga

------------------------------
Olga Lewis RAC
Regulatory Affairs Consultant
Broomfield CO
United States

Original Message:
Sent: 23-Jun-2021 16:45
From: Jackie Jaskula
Subject: Number of days for MDR tech document review

Hi, all,
Has anyone yet submitted technical documentation to a notified body for MDR certification? We use BSI, and they provide per day cost but haven't provided an estimate on the duration of a standard versus dedicated audit. Of course that can be quite variable depending on the types of questions that come during the audit. Hoping someone has some real experience.
Thanks,
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Hi Jackie;

Our BSI quote included the EU MDR QMS upgrade audit and CE assessment for three Class IIa and one Class IIb SaMD audited separately.

Thanks,
Shelley Looby

------------------------------
Shelley Looby
Director, Regulatory Affairs & Quality Assurance
Kansas City MO
United States
------------------------------

Original Message:
Sent: 25-Jun-2021 16:39
From: Jackie Jaskula
Subject: Number of days for MDR tech document review

Shelley, do you mind sharing a little more? This seems like the cost for a standard audit as opposed to dedicated. Is that right? Are your 4 Class IIa systems grouped together and sampled or are they all audited independently.
Thanks again and have a great weekend!
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA

Original Message:
Sent: 25-Jun-2021 09:54
From: Shelley Looby
Subject: Number of days for MDR tech document review

Hi Jackie;

Our quote from BSI for the EU MDR QMS audit plus CE assessment audits for 4 Class IIa and one Class IIb devices was approximately $176,000 USD.

------------------------------
Shelley Looby
Director, Regulatory Affairs & Quality Assurance
Kansas City MO
United States

Original Message:
Sent: 24-Jun-2021 09:37
From: Jackie Jaskula
Subject: Number of days for MDR tech document review

Olga,

Thank you so much for your very thorough response, especially the advice on using the dedicated route. This will greatly facilitate our application process and reviews.

Jackie

Original Message:
Sent: 6/24/2021 8:33:00 AM
From: Olga Lewis
Subject: RE: Number of days for MDR tech document review

Hi Jackie,
based on your portfolio, I am assuming you will submit for class IIa and IIb implantables, both WET and non-WET (Ir, Is not going the same route so not mentioning it here). Not sure if any of your devices were up classified to class III but Class III timelines are still comparable to class IIb non-WET. I have worked with BSI Ortho-Dental branch on MDR submissions. For class IIa, if file is complete according to the BSI completeness checklist and the manufacturer responds in a timely manner, the review can be done in as little as 3 months from the day it was picked for the administrative review. For IIb implantables, for first couple files I would plan for 9 months. Then, if feedback from first couple files is applied to the rest of submissions, timeline may be shorten but will still plan minimum 6 months. This is for a dedicated review. About 70% MDR submissions are requesting dedicated review with BSI and I strongly recommend a dedicated route for the first file. Otherwise, you will wait a while to be put on the schedule and won't be able to apply feedback form BSI that you receive for your first fil to other files you will be working on. Please keep in mind that these estimated timelines are from the day when BSI does the administrative review of the file. First, the proposal needs to be signed and your file needs to be put on the schedule. Even though BSI is great and responsive, it can take between 2-8 weeks (from my experience) since the volume of files they receive is very high.
BSI provides good guidance and tools so following their completeness checklist for the submissions can really shorten the review time.
Hope it helps.
Olga

------------------------------
Olga Lewis RAC
Regulatory Affairs Consultant
Broomfield CO
United States

Original Message:
Sent: 23-Jun-2021 16:45
From: Jackie Jaskula
Subject: Number of days for MDR tech document review

Hi, all,
Has anyone yet submitted technical documentation to a notified body for MDR certification? We use BSI, and they provide per day cost but haven't provided an estimate on the duration of a standard versus dedicated audit. Of course that can be quite variable depending on the types of questions that come during the audit. Hoping someone has some real experience.
Thanks,
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Thanks!

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Original Message:
Sent: 28-Jun-2021 08:42
From: Shelley Looby
Subject: Number of days for MDR tech document review

Hi Jackie;

Our BSI quote included the EU MDR QMS upgrade audit and CE assessment for three Class IIa and one Class IIb SaMD audited separately.

Thanks,
Shelley Looby

------------------------------
Shelley Looby
Director, Regulatory Affairs & Quality Assurance
Kansas City MO
United States

Original Message:
Sent: 25-Jun-2021 16:39
From: Jackie Jaskula
Subject: Number of days for MDR tech document review

Shelley, do you mind sharing a little more? This seems like the cost for a standard audit as opposed to dedicated. Is that right? Are your 4 Class IIa systems grouped together and sampled or are they all audited independently.
Thanks again and have a great weekend!
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA

Original Message:
Sent: 25-Jun-2021 09:54
From: Shelley Looby
Subject: Number of days for MDR tech document review

Hi Jackie;

Our quote from BSI for the EU MDR QMS audit plus CE assessment audits for 4 Class IIa and one Class IIb devices was approximately $176,000 USD.

------------------------------
Shelley Looby
Director, Regulatory Affairs & Quality Assurance
Kansas City MO
United States

Original Message:
Sent: 24-Jun-2021 09:37
From: Jackie Jaskula
Subject: Number of days for MDR tech document review

Olga,

Thank you so much for your very thorough response, especially the advice on using the dedicated route. This will greatly facilitate our application process and reviews.

Jackie

Original Message:
Sent: 6/24/2021 8:33:00 AM
From: Olga Lewis
Subject: RE: Number of days for MDR tech document review

Hi Jackie,
based on your portfolio, I am assuming you will submit for class IIa and IIb implantables, both WET and non-WET (Ir, Is not going the same route so not mentioning it here). Not sure if any of your devices were up classified to class III but Class III timelines are still comparable to class IIb non-WET. I have worked with BSI Ortho-Dental branch on MDR submissions. For class IIa, if file is complete according to the BSI completeness checklist and the manufacturer responds in a timely manner, the review can be done in as little as 3 months from the day it was picked for the administrative review. For IIb implantables, for first couple files I would plan for 9 months. Then, if feedback from first couple files is applied to the rest of submissions, timeline may be shorten but will still plan minimum 6 months. This is for a dedicated review. About 70% MDR submissions are requesting dedicated review with BSI and I strongly recommend a dedicated route for the first file. Otherwise, you will wait a while to be put on the schedule and won't be able to apply feedback form BSI that you receive for your first fil to other files you will be working on. Please keep in mind that these estimated timelines are from the day when BSI does the administrative review of the file. First, the proposal needs to be signed and your file needs to be put on the schedule. Even though BSI is great and responsive, it can take between 2-8 weeks (from my experience) since the volume of files they receive is very high.
BSI provides good guidance and tools so following their completeness checklist for the submissions can really shorten the review time.
Hope it helps.
Olga

------------------------------
Olga Lewis RAC
Regulatory Affairs Consultant
Broomfield CO
United States

Original Message:
Sent: 23-Jun-2021 16:45
From: Jackie Jaskula
Subject: Number of days for MDR tech document review

Hi, all,
Has anyone yet submitted technical documentation to a notified body for MDR certification? We use BSI, and they provide per day cost but haven't provided an estimate on the duration of a standard versus dedicated audit. Of course that can be quite variable depending on the types of questions that come during the audit. Hoping someone has some real experience.
Thanks,
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

I would say a minimum of 3 months which I think is a really fast if not unlikely time period for any tech doc review for MDR in my experience so far even for a IIa device that I have seen yet. to upwards of a year.  Remember I think all notified Bodies are doing 3 strikes and your out reviews now or at least the majority of them are doing that.  So, be really careful and be fully prepared.  one review I did the product was so unprepared the client had to withdraw the application as there were so many issues they realized they were not ready so do anything to prepare as possible that your NB provides you.  Most of the bigger and even the smaller NBs are providing lots of guidance documents to help you in setting up and providing the proper information for your submission to them.  Follow the NB instructions as closely as possible. Follow their application process to the letter of the their requirements and talk to them in advance to make sure you understand the processes clearly.  One mistake could set you back weeks if not months in your timeline.

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 23-Jun-2021 16:45
From: Jackie Jaskula
Subject: Number of days for MDR tech document review

Hi, all,
Has anyone yet submitted technical documentation to a notified body for MDR certification? We use BSI, and they provide per day cost but haven't provided an estimate on the duration of a standard versus dedicated audit. Of course that can be quite variable depending on the types of questions that come during the audit. Hoping someone has some real experience.
Thanks,
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Original Message:
Sent: 6/25/2021 12:04:00 PM
From: Leonard Eisner
Subject: RE: Number of days for MDR tech document review

I would say a minimum of 3 months which I think is a really fast if not unlikely time period for any tech doc review for MDR in my experience so far even for a IIa device that I have seen yet. to upwards of a year.  Remember I think all notified Bodies are doing 3 strikes and your out reviews now or at least the majority of them are doing that.  So, be really careful and be fully prepared.  one review I did the product was so unprepared the client had to withdraw the application as there were so many issues they realized they were not ready so do anything to prepare as possible that your NB provides you.  Most of the bigger and even the smaller NBs are providing lots of guidance documents to help you in setting up and providing the proper information for your submission to them.  Follow the NB instructions as closely as possible. Follow their application process to the letter of the their requirements and talk to them in advance to make sure you understand the processes clearly.  One mistake could set you back weeks if not months in your timeline.

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 23-Jun-2021 16:45
From: Jackie Jaskula
Subject: Number of days for MDR tech document review

Hi, all,
Has anyone yet submitted technical documentation to a notified body for MDR certification? We use BSI, and they provide per day cost but haven't provided an estimate on the duration of a standard versus dedicated audit. Of course that can be quite variable depending on the types of questions that come during the audit. Hoping someone has some real experience.
Thanks,
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Our NB indicated 9 months. Application has an initial administrative review similar to FDA 510(k) to make sure the application is complete. This is followed by up to two more rounds of back and forth and if it misses that deadline the application is rejected.

This makes me worried that an element will be overlooked for two rounds, brought up on the final round, and create an issue. I have yet to experience that so this is all hypothetical. In the past, meetings online also serve to help us meet our goals with NBs.
------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Original Message:
Sent: 25-Jun-2021 16:34
From: Jackie Jaskula
Subject: Number of days for MDR tech document review

Thanks for the feedback, Leonard. Our NB has been doing a 3-strikes and you're out approach for MDD, so we're ready for that. Our MDD cert renewal was rigorous, and we learned many good lessons from our NB (painful but good.) We have a wide variety of systems to coordinate and are trying to be very mindful of establishing the timing in the application to avoid any gaps in certification as we approach the 2024 date.

Jackie

Original Message:
Sent: 6/25/2021 12:04:00 PM
From: Leonard Eisner
Subject: RE: Number of days for MDR tech document review

I would say a minimum of 3 months which I think is a really fast if not unlikely time period for any tech doc review for MDR in my experience so far even for a IIa device that I have seen yet. to upwards of a year.  Remember I think all notified Bodies are doing 3 strikes and your out reviews now or at least the majority of them are doing that.  So, be really careful and be fully prepared.  one review I did the product was so unprepared the client had to withdraw the application as there were so many issues they realized they were not ready so do anything to prepare as possible that your NB provides you.  Most of the bigger and even the smaller NBs are providing lots of guidance documents to help you in setting up and providing the proper information for your submission to them.  Follow the NB instructions as closely as possible. Follow their application process to the letter of the their requirements and talk to them in advance to make sure you understand the processes clearly.  One mistake could set you back weeks if not months in your timeline.

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Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com

Original Message:
Sent: 23-Jun-2021 16:45
From: Jackie Jaskula
Subject: Number of days for MDR tech document review

Hi, all,
Has anyone yet submitted technical documentation to a notified body for MDR certification? We use BSI, and they provide per day cost but haven't provided an estimate on the duration of a standard versus dedicated audit. Of course that can be quite variable depending on the types of questions that come during the audit. Hoping someone has some real experience.
Thanks,
Jackie

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Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
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