Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Regulatory Community,

Within the context of a licensing agreement in which you are the specification developer and licencor, who should maintain the Design History File?  The license agreement puts limitations on the use of the technology by the licensee, as well as a current patent (owned by the licencor). 

I think the DHF, DHR, and DMR should all be maintained by the licensee, but I want to make sure I am not overlooking some IP issue or other circumstance that may become problematic in the future.

Any guidance would be appreciated.

Kind Regards,

Anon Y. Mous

Anonymous,

As usual, the answer to this is "it depends." In short, the organization of the responsibility for these deliverables will vary based on the skill sets and business arrangements of the partners. Some of the most common arrangements can be:

- Design firm owns the DHF documents, while a separate "OEM" owns the DHR & DMR. Contract will cover ownership, as well as expectations around communications, testing etc

- the company that labels the product takes responsibility for design, manufacture and distribution - even while using partners to design and/or make the device

- a company owns the design and manufacturing but uses a 3rd party to sell or distribute (under one name or the other)

 - an IP developer licenses the technology in a specific area to another, who then owns ALL of the DHF, DHR, DMR

In short the possibilities are endless, and much depends on your business strategies - what you want to be good at, what you want to own, how strong you are in holding suppliers accountable etc.

g-

------------------------------
Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States
------------------------------

Original Message:
Sent: 26-Jun-2017 17:29
From: Anonymous Member
Subject: Design History File

This message was posted by a user wishing to remain anonymous

Regulatory Community,

Within the context of a licensing agreement in which you are the specification developer and licencor, who should maintain the Design History File?  The license agreement puts limitations on the use of the technology by the licensee, as well as a current patent (owned by the licencor). 

I think the DHF, DHR, and DMR should all be maintained by the licensee, but I want to make sure I am not overlooking some IP issue or other circumstance that may become problematic in the future.

Any guidance would be appreciated.

Kind Regards,

Anon Y. Mous

In short,

• The person/organization who "does the designing" and in doing so creates the product design should maintain (a full copy of) the DHF.
• The person/organization who's name is on the product should maintain (a full copy of) the DHF and understand it well enough to explain it to an inspector.

Leaving the DHF with the designing organization who may have contractual responsibility for maintaining it; and where it may be occasionally reviewed by the labeled manufacturer (under audits, etc.) involves risks that many companies do not fully appreciate.

There is no substitute for the labeled manufacturer understanding the design processes very well, whether they perform the design or hire it out.

------------------------------
David Ledwig, RAC, CQA
Principal Consultant
Practical Compliance, LLC
ledwigd@practicalcompliance.com
O - (828) 862-8555
M - (828) 508-6535
------------------------------

Original Message:
Sent: 26-Jun-2017 17:29
From: Anonymous Member
Subject: Design History File

This message was posted by a user wishing to remain anonymous

Regulatory Community,

Within the context of a licensing agreement in which you are the specification developer and licencor, who should maintain the Design History File?  The license agreement puts limitations on the use of the technology by the licensee, as well as a current patent (owned by the licencor). 

I think the DHF, DHR, and DMR should all be maintained by the licensee, but I want to make sure I am not overlooking some IP issue or other circumstance that may become problematic in the future.

Any guidance would be appreciated.

Kind Regards,

Anon Y. Mous

I still believe that it depends. I am pretty aware of the risks both ways. That said, many start-ups (including the one I am at) do not have a deep understanding of design controls. Thus, I have walked into situations where, if the manufacturer had it, they would constantly be making changes without data and appropriate controls - where the vendor I like to work with on the design side has a much more robust system and I would not have that concern. Yes, over time, we usually grow to the point we make sure we have a copy and control of entire DHF, but it depends on the relative strengths and weaknesses of the companies involved.

g-

------------------------------
Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States
------------------------------

Original Message:
Sent: 28-Jun-2017 10:19
From: David Ledwig
Subject: Design History File

In short,

• The person/organization who "does the designing" and in doing so creates the product design should maintain (a full copy of) the DHF.
• The person/organization who's name is on the product should maintain (a full copy of) the DHF and understand it well enough to explain it to an inspector.

Leaving the DHF with the designing organization who may have contractual responsibility for maintaining it; and where it may be occasionally reviewed by the labeled manufacturer (under audits, etc.) involves risks that many companies do not fully appreciate.

There is no substitute for the labeled manufacturer understanding the design processes very well, whether they perform the design or hire it out.

------------------------------
David Ledwig, RAC, CQA
Principal Consultant
Practical Compliance, LLC
ledwigd@practicalcompliance.com
O - (828) 862-8555
M - (828) 508-6535
------------------------------

Original Message:
Sent: 26-Jun-2017 17:29
From: Anonymous Member
Subject: Design History File

This message was posted by a user wishing to remain anonymous

Regulatory Community,

Within the context of a licensing agreement in which you are the specification developer and licencor, who should maintain the Design History File?  The license agreement puts limitations on the use of the technology by the licensee, as well as a current patent (owned by the licencor). 

I think the DHF, DHR, and DMR should all be maintained by the licensee, but I want to make sure I am not overlooking some IP issue or other circumstance that may become problematic in the future.

Any guidance would be appreciated.

Kind Regards,

Anon Y. Mous

If your name is on the medical device, I would recommend having access to the DHF.

Yes, the other comments are accurate. 

But solely relying on a third party to maintain a DHF can be fraught with problems.

Ultimately, it is your responsibility.

------------------------------
Jon Speer
greenlight.guru
Indianapolis IN
United States
------------------------------

Original Message:
Sent: 29-Jun-2017 13:54
From: Ginger Glaser
Subject: Design History File

I still believe that it depends. I am pretty aware of the risks both ways. That said, many start-ups (including the one I am at) do not have a deep understanding of design controls. Thus, I have walked into situations where, if the manufacturer had it, they would constantly be making changes without data and appropriate controls - where the vendor I like to work with on the design side has a much more robust system and I would not have that concern. Yes, over time, we usually grow to the point we make sure we have a copy and control of entire DHF, but it depends on the relative strengths and weaknesses of the companies involved.

g-

------------------------------
Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States
------------------------------

Original Message:
Sent: 28-Jun-2017 10:19
From: David Ledwig
Subject: Design History File

In short,

• The person/organization who "does the designing" and in doing so creates the product design should maintain (a full copy of) the DHF.
• The person/organization who's name is on the product should maintain (a full copy of) the DHF and understand it well enough to explain it to an inspector.

Leaving the DHF with the designing organization who may have contractual responsibility for maintaining it; and where it may be occasionally reviewed by the labeled manufacturer (under audits, etc.) involves risks that many companies do not fully appreciate.

There is no substitute for the labeled manufacturer understanding the design processes very well, whether they perform the design or hire it out.

------------------------------
David Ledwig, RAC, CQA
Principal Consultant
Practical Compliance, LLC
ledwigd@practicalcompliance.com
O - (828) 862-8555
M - (828) 508-6535
------------------------------

Original Message:
Sent: 26-Jun-2017 17:29
From: Anonymous Member
Subject: Design History File

This message was posted by a user wishing to remain anonymous

Regulatory Community,

Within the context of a licensing agreement in which you are the specification developer and licencor, who should maintain the Design History File?  The license agreement puts limitations on the use of the technology by the licensee, as well as a current patent (owned by the licencor). 

I think the DHF, DHR, and DMR should all be maintained by the licensee, but I want to make sure I am not overlooking some IP issue or other circumstance that may become problematic in the future.

Any guidance would be appreciated.

Kind Regards,

Anon Y. Mous

​My understanding is that in Europe under the new Medical Device Regulation the legal manufacturer (= the labeller) must hold the technical file in its entirety. A certain UK notified body has already started pushing this concept even if the new MDR is not in mandatory yet, based on a certain interpretation of the current Med Dev Directive. Having hold of the technical file does not mean that they are supposed to modify it. Consequently, the contract between the licensor and the licensee needs to include provisions for such technical file been shared in it entirety (there are exception applying), regardless on who is responsible for what. However my understanding is that the ultimate responsible for the consequences coming from the content of the technical file is the legal manufacture.


------------------------------
Lorenzo Muratori
Elekta
West Sussex
United Kingdom
------------------------------

Original Message:
Sent: 01-Jul-2017 13:05
From: Jon Speer
Subject: Design History File

If your name is on the medical device, I would recommend having access to the DHF.

Yes, the other comments are accurate. 

But solely relying on a third party to maintain a DHF can be fraught with problems.

Ultimately, it is your responsibility.

------------------------------
Jon Speer
greenlight.guru
Indianapolis IN
United States
------------------------------

Original Message:
Sent: 29-Jun-2017 13:54
From: Ginger Glaser
Subject: Design History File

I still believe that it depends. I am pretty aware of the risks both ways. That said, many start-ups (including the one I am at) do not have a deep understanding of design controls. Thus, I have walked into situations where, if the manufacturer had it, they would constantly be making changes without data and appropriate controls - where the vendor I like to work with on the design side has a much more robust system and I would not have that concern. Yes, over time, we usually grow to the point we make sure we have a copy and control of entire DHF, but it depends on the relative strengths and weaknesses of the companies involved.

g-

------------------------------
Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States
------------------------------

Original Message:
Sent: 28-Jun-2017 10:19
From: David Ledwig
Subject: Design History File

In short,

• The person/organization who "does the designing" and in doing so creates the product design should maintain (a full copy of) the DHF.
• The person/organization who's name is on the product should maintain (a full copy of) the DHF and understand it well enough to explain it to an inspector.

Leaving the DHF with the designing organization who may have contractual responsibility for maintaining it; and where it may be occasionally reviewed by the labeled manufacturer (under audits, etc.) involves risks that many companies do not fully appreciate.

There is no substitute for the labeled manufacturer understanding the design processes very well, whether they perform the design or hire it out.

------------------------------
David Ledwig, RAC, CQA
Principal Consultant
Practical Compliance, LLC
ledwigd@practicalcompliance.com
O - (828) 862-8555
M - (828) 508-6535
------------------------------

Original Message:
Sent: 26-Jun-2017 17:29
From: Anonymous Member
Subject: Design History File

This message was posted by a user wishing to remain anonymous

Regulatory Community,

Within the context of a licensing agreement in which you are the specification developer and licencor, who should maintain the Design History File?  The license agreement puts limitations on the use of the technology by the licensee, as well as a current patent (owned by the licencor). 

I think the DHF, DHR, and DMR should all be maintained by the licensee, but I want to make sure I am not overlooking some IP issue or other circumstance that may become problematic in the future.

Any guidance would be appreciated.

Kind Regards,

Anon Y. Mous

I think this is true of the technical file - which is not exactly the same thing as the DHF (though elements are obviously parts of both)

g-

------------------------------
Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States
------------------------------

Original Message:
Sent: 06-Jul-2017 12:39
From: Lorenzo Muratori
Subject: Design History File

​My understanding is that in Europe under the new Medical Device Regulation the legal manufacturer (= the labeller) must hold the technical file in its entirety. A certain UK notified body has already started pushing this concept even if the new MDR is not in mandatory yet, based on a certain interpretation of the current Med Dev Directive. Having hold of the technical file does not mean that they are supposed to modify it. Consequently, the contract between the licensor and the licensee needs to include provisions for such technical file been shared in it entirety (there are exception applying), regardless on who is responsible for what. However my understanding is that the ultimate responsible for the consequences coming from the content of the technical file is the legal manufacture.


------------------------------
Lorenzo Muratori
Elekta
West Sussex
United Kingdom
------------------------------

Original Message:
Sent: 01-Jul-2017 13:05
From: Jon Speer
Subject: Design History File

If your name is on the medical device, I would recommend having access to the DHF.

Yes, the other comments are accurate. 

But solely relying on a third party to maintain a DHF can be fraught with problems.

Ultimately, it is your responsibility.

------------------------------
Jon Speer
greenlight.guru
Indianapolis IN
United States
------------------------------

Original Message:
Sent: 29-Jun-2017 13:54
From: Ginger Glaser
Subject: Design History File

I still believe that it depends. I am pretty aware of the risks both ways. That said, many start-ups (including the one I am at) do not have a deep understanding of design controls. Thus, I have walked into situations where, if the manufacturer had it, they would constantly be making changes without data and appropriate controls - where the vendor I like to work with on the design side has a much more robust system and I would not have that concern. Yes, over time, we usually grow to the point we make sure we have a copy and control of entire DHF, but it depends on the relative strengths and weaknesses of the companies involved.

g-

------------------------------
Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States
------------------------------

Original Message:
Sent: 28-Jun-2017 10:19
From: David Ledwig
Subject: Design History File

In short,

• The person/organization who "does the designing" and in doing so creates the product design should maintain (a full copy of) the DHF.
• The person/organization who's name is on the product should maintain (a full copy of) the DHF and understand it well enough to explain it to an inspector.

Leaving the DHF with the designing organization who may have contractual responsibility for maintaining it; and where it may be occasionally reviewed by the labeled manufacturer (under audits, etc.) involves risks that many companies do not fully appreciate.

There is no substitute for the labeled manufacturer understanding the design processes very well, whether they perform the design or hire it out.

------------------------------
David Ledwig, RAC, CQA
Principal Consultant
Practical Compliance, LLC
ledwigd@practicalcompliance.com
O - (828) 862-8555
M - (828) 508-6535
------------------------------

Original Message:
Sent: 26-Jun-2017 17:29
From: Anonymous Member
Subject: Design History File

This message was posted by a user wishing to remain anonymous

Regulatory Community,

Within the context of a licensing agreement in which you are the specification developer and licencor, who should maintain the Design History File?  The license agreement puts limitations on the use of the technology by the licensee, as well as a current patent (owned by the licencor). 

I think the DHF, DHR, and DMR should all be maintained by the licensee, but I want to make sure I am not overlooking some IP issue or other circumstance that may become problematic in the future.

Any guidance would be appreciated.

Kind Regards,

Anon Y. Mous