Regulatory Open Forum

Hello
I have some small customers with class I EU products in the process of transitioning to MDR.  They do not have anyone in house with the appropriate background to be "Person Responsible for Regulatory Compliance."  I am going to expand my services to represent them as their PRRC.   I am struggling to identify the right price to charge for this, right type and level of insurance (assuming errors and omissions alone isn't appropriate), if I need to create a separate business for this service to protect my existing business, and appropriate terms for a contract to be in place.  It is a huge responsibility to represent a client's products in this way.  Has anyone done this yet? Interested in how other consultants are thinking!

Thank you

------------------------------
Michelle Lott RAC
Principal & Founder
michelle@leanraqa.com
------------------------------

Hello,

Micro and small manufacturers3 (paragraph 2)
"Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal."

As defined in https://ec.europa.eu/docsroom/documents/36166

Franky

------------------------------
Franky Dubois
QA/RA Manager
Gent
Belgium
------------------------------

Original Message:
Sent: 19-Mar-2020 15:52
From: Michelle Lott
Subject: Person Responsible for Regulatory Compliance

Hello
I have some small customers with class I EU products in the process of transitioning to MDR.  They do not have anyone in house with the appropriate background to be "Person Responsible for Regulatory Compliance."  I am going to expand my services to represent them as their PRRC.   I am struggling to identify the right price to charge for this, right type and level of insurance (assuming errors and omissions alone isn't appropriate), if I need to create a separate business for this service to protect my existing business, and appropriate terms for a contract to be in place.  It is a huge responsibility to represent a client's products in this way.  Has anyone done this yet? Interested in how other consultants are thinking!

Thank you

------------------------------
Michelle Lott RAC
Principal & Founder
michelle@leanraqa.com
------------------------------

Hi Franky
That is exactly my concern - "shall have such person permanently and continuously at their disposal."  In this case, I would be representing my clients in this capacity.  I am assuming the responsibility and liability that a person within the company would but that person would be covered by the company's insurance and level protection.  I am not.  I am trying to make sure I have the business practices in place and understand the value of being this person for them.  Any thoughts you have on that are appreciated.

Thank you
Michelle

------------------------------
Michelle Lott RAC
Principal & Founder
michelle@leanraqa.com
------------------------------

Original Message:
Sent: 20-Mar-2020 04:01
From: Franky Dubois
Subject: Person Responsible for Regulatory Compliance

Hello,

Micro and small manufacturers3 (paragraph 2)
"Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal."

As defined in https://ec.europa.eu/docsroom/documents/36166

Franky

------------------------------
Franky Dubois
QA/RA Manager
Gent
Belgium

Original Message:
Sent: 19-Mar-2020 15:52
From: Michelle Lott
Subject: Person Responsible for Regulatory Compliance

Hello
I have some small customers with class I EU products in the process of transitioning to MDR.  They do not have anyone in house with the appropriate background to be "Person Responsible for Regulatory Compliance."  I am going to expand my services to represent them as their PRRC.   I am struggling to identify the right price to charge for this, right type and level of insurance (assuming errors and omissions alone isn't appropriate), if I need to create a separate business for this service to protect my existing business, and appropriate terms for a contract to be in place.  It is a huge responsibility to represent a client's products in this way.  Has anyone done this yet? Interested in how other consultants are thinking!

Thank you

------------------------------
Michelle Lott RAC
Principal & Founder
michelle@leanraqa.com
------------------------------

Hi,

Franky, i think Michelle knows well the role and responsibilities of PRRC.
Michelle, as I can see it, it is a huge responsibility, because these companies do not have even the basic knowledge of the regulation and the guidelines.
If you have a lot of companies, it is difficult to track all the procedures with the appropriate attention.
You know all the things you have to check and one extra problem is that many of these companies have a large variety of activities.

I believe you need a contract with an experience insurance company, because this role is of great importance. Imagine if a batch is released and there are non-conformities unidentified in the system. I assume that you will share most of the responsibility in this case.
As I can see it, if a freelancer will take this responsibility, he will have only a few companies, where he can oversight most of the process and also this will be his primary business, not just a part-time occupation. Otherwise, some of the big consulting companies will undertake this activity because they could potentially have the resources to support many companies.
Good luck with that!


------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece
------------------------------

Original Message:
Sent: 19-Mar-2020 15:52
From: Michelle Lott
Subject: Person Responsible for Regulatory Compliance

Hello
I have some small customers with class I EU products in the process of transitioning to MDR.  They do not have anyone in house with the appropriate background to be "Person Responsible for Regulatory Compliance."  I am going to expand my services to represent them as their PRRC.   I am struggling to identify the right price to charge for this, right type and level of insurance (assuming errors and omissions alone isn't appropriate), if I need to create a separate business for this service to protect my existing business, and appropriate terms for a contract to be in place.  It is a huge responsibility to represent a client's products in this way.  Has anyone done this yet? Interested in how other consultants are thinking!

Thank you

------------------------------
Michelle Lott RAC
Principal & Founder
michelle@leanraqa.com
------------------------------

Hi Michelle,

This is definitely an important role within a medical device company now selling and distributing products in the EU.  First, you are right should have personal liability insurance to cover any "issues" arising when the company does not follow the requirements and you as a person/company get pulled into liability or litigation.  I think part or all of that cost could be passed along.  If you have say 4 companies and your liability is $4k USD a year, than a minimum $1k each?  Maybe?  Second, think about the time you would spend working with the clients to review their quality system, so as an example at least once a year should be participating in the management review at maybe 4 hours.  Then 'x' hours over a year to help support, ask questions, etc.  Then estimate the number of hours per year times your hourly rate.

Personally, I think in the figures of 2,500 to 5,000 Euro a year is not unreasonable for a Class I, low risk manufacturer.  Of course this would be adjusted based on the amount of support needing to provide, risk of the device, type of device, number of product families existing, etc.  I know QPs in the pharma industry charge twice or three times this - but certainly pharma there is huge risk from adverse effects, side effects from drugs.  Theoretically Class I low risk devices should pose minimum patient health or safety concerns, so this is something to take into consideration.  Definitely I would recommend having this service as a "company" from a liability standpoint, AND definitely have a contract in place that is renewable at least once a year or every other year - do not leave it open ended.

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

Original Message:
Sent: 20-Mar-2020 04:16
From: Spyros Drivelos
Subject: Person Responsible for Regulatory Compliance

Hi,

Franky, i think Michelle knows well the role and responsibilities of PRRC.
Michelle, as I can see it, it is a huge responsibility, because these companies do not have even the basic knowledge of the regulation and the guidelines.
If you have a lot of companies, it is difficult to track all the procedures with the appropriate attention.
You know all the things you have to check and one extra problem is that many of these companies have a large variety of activities.

I believe you need a contract with an experience insurance company, because this role is of great importance. Imagine if a batch is released and there are non-conformities unidentified in the system. I assume that you will share most of the responsibility in this case.
As I can see it, if a freelancer will take this responsibility, he will have only a few companies, where he can oversight most of the process and also this will be his primary business, not just a part-time occupation. Otherwise, some of the big consulting companies will undertake this activity because they could potentially have the resources to support many companies.
Good luck with that!


------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece

Original Message:
Sent: 19-Mar-2020 15:52
From: Michelle Lott
Subject: Person Responsible for Regulatory Compliance

Hello
I have some small customers with class I EU products in the process of transitioning to MDR.  They do not have anyone in house with the appropriate background to be "Person Responsible for Regulatory Compliance."  I am going to expand my services to represent them as their PRRC.   I am struggling to identify the right price to charge for this, right type and level of insurance (assuming errors and omissions alone isn't appropriate), if I need to create a separate business for this service to protect my existing business, and appropriate terms for a contract to be in place.  It is a huge responsibility to represent a client's products in this way.  Has anyone done this yet? Interested in how other consultants are thinking!

Thank you

------------------------------
Michelle Lott RAC
Principal & Founder
michelle@leanraqa.com
------------------------------

Very helpful Spyros and Richard.  I appreciate the perspectives and the help quantifying the value.

------------------------------
Michelle Lott RAC
Principal & Founder
michelle@leanraqa.com
------------------------------

Original Message:
Sent: 20-Mar-2020 08:58
From: Richard Vincins
Subject: Person Responsible for Regulatory Compliance

Hi Michelle,

This is definitely an important role within a medical device company now selling and distributing products in the EU.  First, you are right should have personal liability insurance to cover any "issues" arising when the company does not follow the requirements and you as a person/company get pulled into liability or litigation.  I think part or all of that cost could be passed along.  If you have say 4 companies and your liability is $4k USD a year, than a minimum $1k each?  Maybe?  Second, think about the time you would spend working with the clients to review their quality system, so as an example at least once a year should be participating in the management review at maybe 4 hours.  Then 'x' hours over a year to help support, ask questions, etc.  Then estimate the number of hours per year times your hourly rate.

Personally, I think in the figures of 2,500 to 5,000 Euro a year is not unreasonable for a Class I, low risk manufacturer.  Of course this would be adjusted based on the amount of support needing to provide, risk of the device, type of device, number of product families existing, etc.  I know QPs in the pharma industry charge twice or three times this - but certainly pharma there is huge risk from adverse effects, side effects from drugs.  Theoretically Class I low risk devices should pose minimum patient health or safety concerns, so this is something to take into consideration.  Definitely I would recommend having this service as a "company" from a liability standpoint, AND definitely have a contract in place that is renewable at least once a year or every other year - do not leave it open ended.

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

Original Message:
Sent: 20-Mar-2020 04:16
From: Spyros Drivelos
Subject: Person Responsible for Regulatory Compliance

Hi,

Franky, i think Michelle knows well the role and responsibilities of PRRC.
Michelle, as I can see it, it is a huge responsibility, because these companies do not have even the basic knowledge of the regulation and the guidelines.
If you have a lot of companies, it is difficult to track all the procedures with the appropriate attention.
You know all the things you have to check and one extra problem is that many of these companies have a large variety of activities.

I believe you need a contract with an experience insurance company, because this role is of great importance. Imagine if a batch is released and there are non-conformities unidentified in the system. I assume that you will share most of the responsibility in this case.
As I can see it, if a freelancer will take this responsibility, he will have only a few companies, where he can oversight most of the process and also this will be his primary business, not just a part-time occupation. Otherwise, some of the big consulting companies will undertake this activity because they could potentially have the resources to support many companies.
Good luck with that!


------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece

Original Message:
Sent: 19-Mar-2020 15:52
From: Michelle Lott
Subject: Person Responsible for Regulatory Compliance

Hello
I have some small customers with class I EU products in the process of transitioning to MDR.  They do not have anyone in house with the appropriate background to be "Person Responsible for Regulatory Compliance."  I am going to expand my services to represent them as their PRRC.   I am struggling to identify the right price to charge for this, right type and level of insurance (assuming errors and omissions alone isn't appropriate), if I need to create a separate business for this service to protect my existing business, and appropriate terms for a contract to be in place.  It is a huge responsibility to represent a client's products in this way.  Has anyone done this yet? Interested in how other consultants are thinking!

Thank you

------------------------------
Michelle Lott RAC
Principal & Founder
michelle@leanraqa.com
------------------------------

Michelle
simpy don´t do it!

------------------------------
Evangelos Tavandzis
Lead Auditor, Consultant
Praha
Czech Republic
------------------------------

Original Message:
Sent: 20-Mar-2020 11:01
From: Michelle Lott
Subject: Person Responsible for Regulatory Compliance

Very helpful Spyros and Richard.  I appreciate the perspectives and the help quantifying the value.

------------------------------
Michelle Lott RAC
Principal & Founder
michelle@leanraqa.com

Original Message:
Sent: 20-Mar-2020 08:58
From: Richard Vincins
Subject: Person Responsible for Regulatory Compliance

Hi Michelle,

This is definitely an important role within a medical device company now selling and distributing products in the EU.  First, you are right should have personal liability insurance to cover any "issues" arising when the company does not follow the requirements and you as a person/company get pulled into liability or litigation.  I think part or all of that cost could be passed along.  If you have say 4 companies and your liability is $4k USD a year, than a minimum $1k each?  Maybe?  Second, think about the time you would spend working with the clients to review their quality system, so as an example at least once a year should be participating in the management review at maybe 4 hours.  Then 'x' hours over a year to help support, ask questions, etc.  Then estimate the number of hours per year times your hourly rate.

Personally, I think in the figures of 2,500 to 5,000 Euro a year is not unreasonable for a Class I, low risk manufacturer.  Of course this would be adjusted based on the amount of support needing to provide, risk of the device, type of device, number of product families existing, etc.  I know QPs in the pharma industry charge twice or three times this - but certainly pharma there is huge risk from adverse effects, side effects from drugs.  Theoretically Class I low risk devices should pose minimum patient health or safety concerns, so this is something to take into consideration.  Definitely I would recommend having this service as a "company" from a liability standpoint, AND definitely have a contract in place that is renewable at least once a year or every other year - do not leave it open ended.

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

Original Message:
Sent: 20-Mar-2020 04:16
From: Spyros Drivelos
Subject: Person Responsible for Regulatory Compliance

Hi,

Franky, i think Michelle knows well the role and responsibilities of PRRC.
Michelle, as I can see it, it is a huge responsibility, because these companies do not have even the basic knowledge of the regulation and the guidelines.
If you have a lot of companies, it is difficult to track all the procedures with the appropriate attention.
You know all the things you have to check and one extra problem is that many of these companies have a large variety of activities.

I believe you need a contract with an experience insurance company, because this role is of great importance. Imagine if a batch is released and there are non-conformities unidentified in the system. I assume that you will share most of the responsibility in this case.
As I can see it, if a freelancer will take this responsibility, he will have only a few companies, where he can oversight most of the process and also this will be his primary business, not just a part-time occupation. Otherwise, some of the big consulting companies will undertake this activity because they could potentially have the resources to support many companies.
Good luck with that!


------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece

Original Message:
Sent: 19-Mar-2020 15:52
From: Michelle Lott
Subject: Person Responsible for Regulatory Compliance

Hello
I have some small customers with class I EU products in the process of transitioning to MDR.  They do not have anyone in house with the appropriate background to be "Person Responsible for Regulatory Compliance."  I am going to expand my services to represent them as their PRRC.   I am struggling to identify the right price to charge for this, right type and level of insurance (assuming errors and omissions alone isn't appropriate), if I need to create a separate business for this service to protect my existing business, and appropriate terms for a contract to be in place.  It is a huge responsibility to represent a client's products in this way.  Has anyone done this yet? Interested in how other consultants are thinking!

Thank you

------------------------------
Michelle Lott RAC
Principal & Founder
michelle@leanraqa.com
------------------------------

Michelle,

I recommend you take on the role.

The EU-MDR is complicated and I infer you are already consulting in the implementation. I also infer that the clients have decided to keep their products on the EU market. (I know of companies who did the analysis and determined it did not make economic sense.)

As a consultant, reputation is important. You do not want the perception that you abandoned your clients. Also, if the client stays in the EU market, they will find an outside PRRC. The obvious question will be why they need you. Presumably the outside PRRC could take on all the consulting tasks.

I don't believe the role of an outside PRRC is that significant in the terms expressed in this thread. Article 15(3) requires that the PRRC ensure, not do. Ensure means that the client has the effective processes in place. You, presumably, have helped them in your consulting role. Ensure also means that you know they follow the processes. This is an auditing function. Presumably, you already conduct internal quality audits for some clients.

I don't see why your current insurance will not cover the consulting and auditing for the ensure role; I believe you already do it.

For fees, under the ensure role you do not need to change your fee structure. For audits, for example, you will do more audits and probably with a shorter interval until you and the client feel comfortable that a robust audit will not generate a nonconformance.

I don't see a need to set up a different company, since the ensure role is what you already do.

You need to verify the client qualifies for an outside PRRC. I've attached an Excel workbook to help.

In your new role as outside PRRC you will perform an outsourced process, so be sure the client sets up the appropriate controls.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 19-Mar-2020 15:52
From: Michelle Lott
Subject: Person Responsible for Regulatory Compliance

Hello
I have some small customers with class I EU products in the process of transitioning to MDR.  They do not have anyone in house with the appropriate background to be "Person Responsible for Regulatory Compliance."  I am going to expand my services to represent them as their PRRC.   I am struggling to identify the right price to charge for this, right type and level of insurance (assuming errors and omissions alone isn't appropriate), if I need to create a separate business for this service to protect my existing business, and appropriate terms for a contract to be in place.  It is a huge responsibility to represent a client's products in this way.  Has anyone done this yet? Interested in how other consultants are thinking!

Thank you

------------------------------
Michelle Lott RAC
Principal & Founder
michelle@leanraqa.com
------------------------------

Hi Michele,

Thank you for asking the question.  My company is looking into how to handle this too.  There is an article in Regulatory Focus written by Randolph Fillmore that talks about this, here is the link 

https://www.raps.org/news-and-articles/news-articles/2020/2/economic-operators-roles-and-obligations-under-eu

There is a section about the responsibilities of the PRRC.  This sounds like a lot of work and responsibility for one person across multiple companies.

Be careful what you sign up for.

I hope others will post how they are handling it.

------------------------------
Philip Reece
Regulatory Affairs Director
Belvidere IL
United States
------------------------------

Original Message:
Sent: 19-Mar-2020 15:52
From: Michelle Lott
Subject: Person Responsible for Regulatory Compliance

Hello
I have some small customers with class I EU products in the process of transitioning to MDR.  They do not have anyone in house with the appropriate background to be "Person Responsible for Regulatory Compliance."  I am going to expand my services to represent them as their PRRC.   I am struggling to identify the right price to charge for this, right type and level of insurance (assuming errors and omissions alone isn't appropriate), if I need to create a separate business for this service to protect my existing business, and appropriate terms for a contract to be in place.  It is a huge responsibility to represent a client's products in this way.  Has anyone done this yet? Interested in how other consultants are thinking!

Thank you

------------------------------
Michelle Lott RAC
Principal & Founder
michelle@leanraqa.com
------------------------------

Hi Michelle

I am looking at this too, but am more than a little leery of doing this role, only because there is no possible way to keep up with all the "relevant " regulatory requirements in each country easily. (E.g. DIN, Royal Decrees..).  That was an advantage working for a large company like 3M. As the Global RA on a product I had the lead, but could rely on the EU AR,  plus dedicated RA in each EU country to identify and explain how each new country regulation was being applied by the authorities.   Just having the coordination role was enough work.  I created the Tech Files and interacted with AR and local RAs and NBs during audits.  I think that is a safer consulting role. It is no different than being the assigned RA who helps client set requirements for and interact with in-country agents in Latin America, Middle East, Asia, etc.

Good luck..I will be curious to see what you decide, as I am  in the same boat. I will probably be looking for a reputable AR soon for a couple clients who do not have a presence in the EU yet, but thankfully do use an MDR accredited NB already.








------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 21-Mar-2020 11:27
From: Philip Reece
Subject: Person Responsible for Regulatory Compliance

Hi Michele,

Thank you for asking the question.  My company is looking into how to handle this too.  There is an article in Regulatory Focus written by Randolph Fillmore that talks about this, here is the link 

https://www.raps.org/news-and-articles/news-articles/2020/2/economic-operators-roles-and-obligations-under-eu

There is a section about the responsibilities of the PRRC.  This sounds like a lot of work and responsibility for one person across multiple companies.

Be careful what you sign up for.

I hope others will post how they are handling it.

------------------------------
Philip Reece
Regulatory Affairs Director
Belvidere IL
United States

Original Message:
Sent: 19-Mar-2020 15:52
From: Michelle Lott
Subject: Person Responsible for Regulatory Compliance

Hello
I have some small customers with class I EU products in the process of transitioning to MDR.  They do not have anyone in house with the appropriate background to be "Person Responsible for Regulatory Compliance."  I am going to expand my services to represent them as their PRRC.   I am struggling to identify the right price to charge for this, right type and level of insurance (assuming errors and omissions alone isn't appropriate), if I need to create a separate business for this service to protect my existing business, and appropriate terms for a contract to be in place.  It is a huge responsibility to represent a client's products in this way.  Has anyone done this yet? Interested in how other consultants are thinking!

Thank you

------------------------------
Michelle Lott RAC
Principal & Founder
michelle@leanraqa.com
------------------------------

Hi Dan and Phillip
Both of your posts were extremely helpful and made me less concerned about taking in the role!  Many thanks!

------------------------------
Michelle Lott RAC
Principal & Founder
michelle@leanraqa.com
------------------------------

Original Message:
Sent: 19-Mar-2020 15:52
From: Michelle Lott
Subject: Person Responsible for Regulatory Compliance

Hello
I have some small customers with class I EU products in the process of transitioning to MDR.  They do not have anyone in house with the appropriate background to be "Person Responsible for Regulatory Compliance."  I am going to expand my services to represent them as their PRRC.   I am struggling to identify the right price to charge for this, right type and level of insurance (assuming errors and omissions alone isn't appropriate), if I need to create a separate business for this service to protect my existing business, and appropriate terms for a contract to be in place.  It is a huge responsibility to represent a client's products in this way.  Has anyone done this yet? Interested in how other consultants are thinking!

Thank you

------------------------------
Michelle Lott RAC
Principal & Founder
michelle@leanraqa.com
------------------------------