Regulatory Open Forum

Dear community,

I'm happy to get your comments and interpretation of the applicable regulations (MDR and 2021/83/EC) for the following case:

A Procedure Pack Producer (PPP) is planning to combine a CE-mark medical device (MD) and an authorized medicinal product (MP) as part of a PP per Article 22 of the MDR. For information, the MP is marketed and registered. Per the MAH license, the MP is provided in an outer box (outer packaging) containing 10 individual MP. Each MP is presented in a pouch (immediate packaging), labelled as required per medicinal regulation. The outer box contains a single Package Leaflet (in summary: one single Package Leaflet and 10 individual MP labelled as required in an outer box). 

The PPP holds a WDA/ Wholesale Distribution Authorisation license and also a ISO 13485 QMS certificate.

When combining the MD and the MP together for the PP, the PPP will open the outer packaging of the MP, take one single 1xMP, make a copy of the MP Package Leaflet and pack it together with the 1xMD (note: all the verifications of mutual compatibility between the MD and MP have been completed as per Art 22; the PP incorporates the information for the user. In addition, when splitting up the 10 unit-box of the MP It's accepted that the condition of each individual MP is not adversely affected).

My open question to the forum is the following: the PPP, holding a WDA, is "opening the box of the MP" and making a copy of the Package Leaflet of the MP to place it as part of the PP:

1) Can I "claim the spirit" of the  MDR Article §16(2)  to consider that splitting-up the MP box and making a copy of the package leaflet are not "manufacturing" activities (MDCG 2021-26), consequently the PPP will not need a MIA-GMP lincense? The QMS in place of the PPP will "control" the activities necessary for the PP.

Thanks in advance for your comments and thoughts!

BR

Dear community,

I'm happy to get your comments and interpretation of the applicable regulations (MDR and 2021/83/EC) for the following case:

A Procedure Pack Producer (PPP) is planning to combine a CE-mark medical device (MD) and an authorized medicinal product (MP) as part of a PP per Article 22 of the MDR. For information, the MP is marketed and registered. Per the MAH license, the MP is provided in an outer box (outer packaging) containing 10 individual MP. Each MP is presented in a pouch (immediate packaging), labelled as required per medicinal regulation. The outer box contains a single Package Leaflet (in summary: one single Package Leaflet and 10 individual MP labelled as required in an outer box). 

The PPP holds a WDA/ Wholesale Distribution Authorisation license and also a ISO 13485 QMS certificate.

When combining the MD and the MP together for the PP, the PPP will open the outer packaging of the MP, take one single 1xMP, make a copy of the MP Package Leaflet and pack it together with the 1xMD (note: all the verifications of mutual compatibility between the MD and MP have been completed as per Art 22; the PP incorporates the information for the user. In addition, when splitting up the 10 unit-box of the MP It's accepted that the condition of each individual MP is not adversely affected).

My open question to the forum is the following: the PPP, holding a WDA, is "opening the box of the MP" and making a copy of the Package Leaflet of the MP to place it as part of the PP:

1) Can I "claim the spirit" of the  MDR Article §16(2)  to consider that splitting-up the MP box and making a copy of the package leaflet are not "manufacturing" activities (MDCG 2021-26), consequently the PPP will not need a MIA-GMP lincense? The QMS in place of the PPP will "control" the activities necessary for the PP.

Thanks in advance for your comments and thoughts!

BR

Dear community,

I'm happy to get your comments and interpretation of the applicable regulations (MDR and 2021/83/EC) for the following case:

A Procedure Pack Producer (PPP) is planning to combine a CE-mark medical device (MD) and an authorized medicinal product (MP) as part of a PP per Article 22 of the MDR. For information, the MP is marketed and registered. Per the MAH license, the MP is provided in an outer box (outer packaging) containing 10 individual MP. Each MP is presented in a pouch (immediate packaging), labelled as required per medicinal regulation. The outer box contains a single Package Leaflet (in summary: one single Package Leaflet and 10 individual MP labelled as required in an outer box). 

The PPP holds a WDA/ Wholesale Distribution Authorisation license and also a ISO 13485 QMS certificate.

When combining the MD and the MP together for the PP, the PPP will open the outer packaging of the MP, take one single 1xMP, make a copy of the MP Package Leaflet and pack it together with the 1xMD (note: all the verifications of mutual compatibility between the MD and MP have been completed as per Art 22; the PP incorporates the information for the user. In addition, when splitting up the 10 unit-box of the MP It's accepted that the condition of each individual MP is not adversely affected).

My open question to the forum is the following: the PPP, holding a WDA, is "opening the box of the MP" and making a copy of the Package Leaflet of the MP to place it as part of the PP:

1) Can I "claim the spirit" of the  MDR Article §16(2)  to consider that splitting-up the MP box and making a copy of the package leaflet are not "manufacturing" activities (MDCG 2021-26), consequently the PPP will not need a MIA-GMP lincense? The QMS in place of the PPP will "control" the activities necessary for the PP.

Thanks in advance for your comments and thoughts!

BR

I sort off agree with Ronald.  A procedure pack does not include a medicinal product.  typically, it includes medical device needed to complete a procedure such as an orthopedic implants, different implants, and different tools. 

Dear community,

I'm happy to get your comments and interpretation of the applicable regulations (MDR and 2021/83/EC) for the following case:

A Procedure Pack Producer (PPP) is planning to combine a CE-mark medical device (MD) and an authorized medicinal product (MP) as part of a PP per Article 22 of the MDR. For information, the MP is marketed and registered. Per the MAH license, the MP is provided in an outer box (outer packaging) containing 10 individual MP. Each MP is presented in a pouch (immediate packaging), labelled as required per medicinal regulation. The outer box contains a single Package Leaflet (in summary: one single Package Leaflet and 10 individual MP labelled as required in an outer box). 

The PPP holds a WDA/ Wholesale Distribution Authorisation license and also a ISO 13485 QMS certificate.

When combining the MD and the MP together for the PP, the PPP will open the outer packaging of the MP, take one single 1xMP, make a copy of the MP Package Leaflet and pack it together with the 1xMD (note: all the verifications of mutual compatibility between the MD and MP have been completed as per Art 22; the PP incorporates the information for the user. In addition, when splitting up the 10 unit-box of the MP It's accepted that the condition of each individual MP is not adversely affected).

My open question to the forum is the following: the PPP, holding a WDA, is "opening the box of the MP" and making a copy of the Package Leaflet of the MP to place it as part of the PP:

1) Can I "claim the spirit" of the  MDR Article §16(2)  to consider that splitting-up the MP box and making a copy of the package leaflet are not "manufacturing" activities (MDCG 2021-26), consequently the PPP will not need a MIA-GMP lincense? The QMS in place of the PPP will "control" the activities necessary for the PP.

Thanks in advance for your comments and thoughts!

BR

Hi Anon

Assuming the directive you refer to here is actually  2001/83/EC. Taking all your stipulations at face value, as far as the MDR goes, I'd say yes this seems to meet all the requirements. I have more doubt about the medicines directive, though. Article 40 requires a manufacturing authorization for "both total and partial manufacture, and for the various processes of dividing up, packaging or presentation", with an exception only for for retail supply by pharmacists in dispensing pharmacies.

Assuming that article is generally necessary for the safety of medicinal products, I don't imagine the MDR would give you leave to ignore it. The MDR talks in several places about the regulatory status of medicinal products in the context of devices, but it doesn't suggest that a device quality management system should be considered equivalent to a pharma manufacturing authorization.

Interesting problem

I sort off agree with Ronald.  A procedure pack does not include a medicinal product.  typically, it includes medical device needed to complete a procedure such as an orthopedic implants, different implants, and different tools. 

Dear community,

I'm happy to get your comments and interpretation of the applicable regulations (MDR and 2021/83/EC) for the following case:

A Procedure Pack Producer (PPP) is planning to combine a CE-mark medical device (MD) and an authorized medicinal product (MP) as part of a PP per Article 22 of the MDR. For information, the MP is marketed and registered. Per the MAH license, the MP is provided in an outer box (outer packaging) containing 10 individual MP. Each MP is presented in a pouch (immediate packaging), labelled as required per medicinal regulation. The outer box contains a single Package Leaflet (in summary: one single Package Leaflet and 10 individual MP labelled as required in an outer box). 

The PPP holds a WDA/ Wholesale Distribution Authorisation license and also a ISO 13485 QMS certificate.

When combining the MD and the MP together for the PP, the PPP will open the outer packaging of the MP, take one single 1xMP, make a copy of the MP Package Leaflet and pack it together with the 1xMD (note: all the verifications of mutual compatibility between the MD and MP have been completed as per Art 22; the PP incorporates the information for the user. In addition, when splitting up the 10 unit-box of the MP It's accepted that the condition of each individual MP is not adversely affected).

My open question to the forum is the following: the PPP, holding a WDA, is "opening the box of the MP" and making a copy of the Package Leaflet of the MP to place it as part of the PP:

1) Can I "claim the spirit" of the  MDR Article §16(2)  to consider that splitting-up the MP box and making a copy of the package leaflet are not "manufacturing" activities (MDCG 2021-26), consequently the PPP will not need a MIA-GMP lincense? The QMS in place of the PPP will "control" the activities necessary for the PP.

Thanks in advance for your comments and thoughts!

BR

Is there labeling on the outer package in addition to what's on the individuals?

Could you persuade the manufacturer to provide you a quantity of individuals?

Hi Anon

Assuming the directive you refer to here is actually  2001/83/EC. Taking all your stipulations at face value, as far as the MDR goes, I'd say yes this seems to meet all the requirements. I have more doubt about the medicines directive, though. Article 40 requires a manufacturing authorization for "both total and partial manufacture, and for the various processes of dividing up, packaging or presentation", with an exception only for for retail supply by pharmacists in dispensing pharmacies.

Assuming that article is generally necessary for the safety of medicinal products, I don't imagine the MDR would give you leave to ignore it. The MDR talks in several places about the regulatory status of medicinal products in the context of devices, but it doesn't suggest that a device quality management system should be considered equivalent to a pharma manufacturing authorization.

Interesting problem

I sort off agree with Ronald.  A procedure pack does not include a medicinal product.  typically, it includes medical device needed to complete a procedure such as an orthopedic implants, different implants, and different tools. 

Dear community,

I'm happy to get your comments and interpretation of the applicable regulations (MDR and 2021/83/EC) for the following case:

A Procedure Pack Producer (PPP) is planning to combine a CE-mark medical device (MD) and an authorized medicinal product (MP) as part of a PP per Article 22 of the MDR. For information, the MP is marketed and registered. Per the MAH license, the MP is provided in an outer box (outer packaging) containing 10 individual MP. Each MP is presented in a pouch (immediate packaging), labelled as required per medicinal regulation. The outer box contains a single Package Leaflet (in summary: one single Package Leaflet and 10 individual MP labelled as required in an outer box). 

The PPP holds a WDA/ Wholesale Distribution Authorisation license and also a ISO 13485 QMS certificate.

When combining the MD and the MP together for the PP, the PPP will open the outer packaging of the MP, take one single 1xMP, make a copy of the MP Package Leaflet and pack it together with the 1xMD (note: all the verifications of mutual compatibility between the MD and MP have been completed as per Art 22; the PP incorporates the information for the user. In addition, when splitting up the 10 unit-box of the MP It's accepted that the condition of each individual MP is not adversely affected).

My open question to the forum is the following: the PPP, holding a WDA, is "opening the box of the MP" and making a copy of the Package Leaflet of the MP to place it as part of the PP:

1) Can I "claim the spirit" of the  MDR Article §16(2)  to consider that splitting-up the MP box and making a copy of the package leaflet are not "manufacturing" activities (MDCG 2021-26), consequently the PPP will not need a MIA-GMP lincense? The QMS in place of the PPP will "control" the activities necessary for the PP.

Thanks in advance for your comments and thoughts!

BR

I sort off agree with Ronald.  A procedure pack does not include a medicinal product.  typically, it includes medical device needed to complete a procedure such as an orthopedic implants, different implants, and different tools. 

Dear community,

I'm happy to get your comments and interpretation of the applicable regulations (MDR and 2021/83/EC) for the following case:

A Procedure Pack Producer (PPP) is planning to combine a CE-mark medical device (MD) and an authorized medicinal product (MP) as part of a PP per Article 22 of the MDR. For information, the MP is marketed and registered. Per the MAH license, the MP is provided in an outer box (outer packaging) containing 10 individual MP. Each MP is presented in a pouch (immediate packaging), labelled as required per medicinal regulation. The outer box contains a single Package Leaflet (in summary: one single Package Leaflet and 10 individual MP labelled as required in an outer box). 

The PPP holds a WDA/ Wholesale Distribution Authorisation license and also a ISO 13485 QMS certificate.

When combining the MD and the MP together for the PP, the PPP will open the outer packaging of the MP, take one single 1xMP, make a copy of the MP Package Leaflet and pack it together with the 1xMD (note: all the verifications of mutual compatibility between the MD and MP have been completed as per Art 22; the PP incorporates the information for the user. In addition, when splitting up the 10 unit-box of the MP It's accepted that the condition of each individual MP is not adversely affected).

My open question to the forum is the following: the PPP, holding a WDA, is "opening the box of the MP" and making a copy of the Package Leaflet of the MP to place it as part of the PP:

1) Can I "claim the spirit" of the  MDR Article §16(2)  to consider that splitting-up the MP box and making a copy of the package leaflet are not "manufacturing" activities (MDCG 2021-26), consequently the PPP will not need a MIA-GMP lincense? The QMS in place of the PPP will "control" the activities necessary for the PP.

Thanks in advance for your comments and thoughts!

BR

Dear Anon,

You have received some good answers that have identified that a procedure pack only includes finished medical devices, and that the PP concept was not intended to address packaging drugs and medical devices together.

The preparation of a product that contains a medical device and a medicinal product is considered a medicinal product, not a medical device.  The only company that is authorized to package these together is the company that holds the MAA.  This would be considered a medicinal product packaging operation, subject to medicinal product regulations and the final product would be considered a new medicinal product presentation that would need to be represented in the PI for the medicinal product.

This could be done by a pharmacist, who is placing multiple prescribed products in a box for a single patient prescription, but not by a manufacturer for distribution.

I know that there are some products that are distributed this way in the USA where the kit includes a usually old, generic drug, but these do not even meet the definition of a convenance kit per US guidance and would need clearance by the FDA. 

I suggest that before going forward that you get the direct input from a lawyer within the EU as I think that this would not be considered legal to put this on the market as a medical device PP.

Good Luck,

I sort off agree with Ronald.  A procedure pack does not include a medicinal product.  typically, it includes medical device needed to complete a procedure such as an orthopedic implants, different implants, and different tools. 

Dear community,

I'm happy to get your comments and interpretation of the applicable regulations (MDR and 2021/83/EC) for the following case:

A Procedure Pack Producer (PPP) is planning to combine a CE-mark medical device (MD) and an authorized medicinal product (MP) as part of a PP per Article 22 of the MDR. For information, the MP is marketed and registered. Per the MAH license, the MP is provided in an outer box (outer packaging) containing 10 individual MP. Each MP is presented in a pouch (immediate packaging), labelled as required per medicinal regulation. The outer box contains a single Package Leaflet (in summary: one single Package Leaflet and 10 individual MP labelled as required in an outer box). 

The PPP holds a WDA/ Wholesale Distribution Authorisation license and also a ISO 13485 QMS certificate.

When combining the MD and the MP together for the PP, the PPP will open the outer packaging of the MP, take one single 1xMP, make a copy of the MP Package Leaflet and pack it together with the 1xMD (note: all the verifications of mutual compatibility between the MD and MP have been completed as per Art 22; the PP incorporates the information for the user. In addition, when splitting up the 10 unit-box of the MP It's accepted that the condition of each individual MP is not adversely affected).

My open question to the forum is the following: the PPP, holding a WDA, is "opening the box of the MP" and making a copy of the Package Leaflet of the MP to place it as part of the PP:

1) Can I "claim the spirit" of the  MDR Article §16(2)  to consider that splitting-up the MP box and making a copy of the package leaflet are not "manufacturing" activities (MDCG 2021-26), consequently the PPP will not need a MIA-GMP lincense? The QMS in place of the PPP will "control" the activities necessary for the PP.

Thanks in advance for your comments and thoughts!

BR

There may be a misunderstanding here: procedure packs are sets of products that have a specific medical purpose and contain at least one medical device. There are some additional specifications that exclude non-integral, copackaged drug-device combinations (I will not go into those details here). But a typical first aid kit would contain disinfectants that qualify as medicinal products. Those kits fall within Article 22. 

In short, the applicable rules all depend on the intended purpose and mode of action of each product included in the procedure pack and on that of the entire procedures set. It is important to get this right and companies should develop good insight in how this works. Reach out if you want help with that. 

Dear Anon,

You have received some good answers that have identified that a procedure pack only includes finished medical devices, and that the PP concept was not intended to address packaging drugs and medical devices together.

The preparation of a product that contains a medical device and a medicinal product is considered a medicinal product, not a medical device.  The only company that is authorized to package these together is the company that holds the MAA.  This would be considered a medicinal product packaging operation, subject to medicinal product regulations and the final product would be considered a new medicinal product presentation that would need to be represented in the PI for the medicinal product.

This could be done by a pharmacist, who is placing multiple prescribed products in a box for a single patient prescription, but not by a manufacturer for distribution.

I know that there are some products that are distributed this way in the USA where the kit includes a usually old, generic drug, but these do not even meet the definition of a convenance kit per US guidance and would need clearance by the FDA. 

I suggest that before going forward that you get the direct input from a lawyer within the EU as I think that this would not be considered legal to put this on the market as a medical device PP.

Good Luck,

I sort off agree with Ronald.  A procedure pack does not include a medicinal product.  typically, it includes medical device needed to complete a procedure such as an orthopedic implants, different implants, and different tools. 

Dear community,

I'm happy to get your comments and interpretation of the applicable regulations (MDR and 2021/83/EC) for the following case:

A Procedure Pack Producer (PPP) is planning to combine a CE-mark medical device (MD) and an authorized medicinal product (MP) as part of a PP per Article 22 of the MDR. For information, the MP is marketed and registered. Per the MAH license, the MP is provided in an outer box (outer packaging) containing 10 individual MP. Each MP is presented in a pouch (immediate packaging), labelled as required per medicinal regulation. The outer box contains a single Package Leaflet (in summary: one single Package Leaflet and 10 individual MP labelled as required in an outer box). 

The PPP holds a WDA/ Wholesale Distribution Authorisation license and also a ISO 13485 QMS certificate.

When combining the MD and the MP together for the PP, the PPP will open the outer packaging of the MP, take one single 1xMP, make a copy of the MP Package Leaflet and pack it together with the 1xMD (note: all the verifications of mutual compatibility between the MD and MP have been completed as per Art 22; the PP incorporates the information for the user. In addition, when splitting up the 10 unit-box of the MP It's accepted that the condition of each individual MP is not adversely affected).

My open question to the forum is the following: the PPP, holding a WDA, is "opening the box of the MP" and making a copy of the Package Leaflet of the MP to place it as part of the PP:

1) Can I "claim the spirit" of the  MDR Article §16(2)  to consider that splitting-up the MP box and making a copy of the package leaflet are not "manufacturing" activities (MDCG 2021-26), consequently the PPP will not need a MIA-GMP lincense? The QMS in place of the PPP will "control" the activities necessary for the PP.

Thanks in advance for your comments and thoughts!

BR

Ronald,

I agree with your commonsense approach to how regulating these PP depends on the intended purpose of the kit as the determining factor.  However, I am not aware of anything in the MDR or any guidance that would allow a manufacturing company (not a pharmacist or hospital) to separate individual drugs from the package in which they are approved to be marketed and market them in this manner.  

It is not that I disagree that this should be the way these are treated, but I am not sure how one "gets there" within the construct of the MDR and guidance.

I would appreciate if you could describe how this might be established.

------------------------------
Lee Leichter RAC
President
P/L Biomedical
Fort Denaud FL
United States

Original Message:
Sent: 01-May-2024 04:20
From: Ronald Boumans
Subject: Procedure Pack (PP). Article 22 & Article 16(2) with a medicinal product in the PP.

There may be a misunderstanding here: procedure packs are sets of products that have a specific medical purpose and contain at least one medical device. There are some additional specifications that exclude non-integral, copackaged drug-device combinations (I will not go into those details here). But a typical first aid kit would contain disinfectants that qualify as medicinal products. Those kits fall within Article 22. 

In short, the applicable rules all depend on the intended purpose and mode of action of each product included in the procedure pack and on that of the entire procedures set. It is important to get this right and companies should develop good insight in how this works. Reach out if you want help with that. 

Dear Anon,

You have received some good answers that have identified that a procedure pack only includes finished medical devices, and that the PP concept was not intended to address packaging drugs and medical devices together.

The preparation of a product that contains a medical device and a medicinal product is considered a medicinal product, not a medical device.  The only company that is authorized to package these together is the company that holds the MAA.  This would be considered a medicinal product packaging operation, subject to medicinal product regulations and the final product would be considered a new medicinal product presentation that would need to be represented in the PI for the medicinal product.

This could be done by a pharmacist, who is placing multiple prescribed products in a box for a single patient prescription, but not by a manufacturer for distribution.

I know that there are some products that are distributed this way in the USA where the kit includes a usually old, generic drug, but these do not even meet the definition of a convenance kit per US guidance and would need clearance by the FDA. 

I suggest that before going forward that you get the direct input from a lawyer within the EU as I think that this would not be considered legal to put this on the market as a medical device PP.

Good Luck,

------------------------------
Lee Leichter RAC
President
P/L Biomedical
Fort Denaud FL
United States

Original Message:
Sent: 29-Apr-2024 16:28
From: Armin Beck
Subject: Procedure Pack (PP). Article 22 & Article 16(2) with a medicinal product in the PP.

I sort off agree with Ronald.  A procedure pack does not include a medicinal product.  typically, it includes medical device needed to complete a procedure such as an orthopedic implants, different implants, and different tools. 

Dear community,

I'm happy to get your comments and interpretation of the applicable regulations (MDR and 2021/83/EC) for the following case:

A Procedure Pack Producer (PPP) is planning to combine a CE-mark medical device (MD) and an authorized medicinal product (MP) as part of a PP per Article 22 of the MDR. For information, the MP is marketed and registered. Per the MAH license, the MP is provided in an outer box (outer packaging) containing 10 individual MP. Each MP is presented in a pouch (immediate packaging), labelled as required per medicinal regulation. The outer box contains a single Package Leaflet (in summary: one single Package Leaflet and 10 individual MP labelled as required in an outer box). 

The PPP holds a WDA/ Wholesale Distribution Authorisation license and also a ISO 13485 QMS certificate.

When combining the MD and the MP together for the PP, the PPP will open the outer packaging of the MP, take one single 1xMP, make a copy of the MP Package Leaflet and pack it together with the 1xMD (note: all the verifications of mutual compatibility between the MD and MP have been completed as per Art 22; the PP incorporates the information for the user. In addition, when splitting up the 10 unit-box of the MP It's accepted that the condition of each individual MP is not adversely affected).

My open question to the forum is the following: the PPP, holding a WDA, is "opening the box of the MP" and making a copy of the Package Leaflet of the MP to place it as part of the PP:

1) Can I "claim the spirit" of the  MDR Article §16(2)  to consider that splitting-up the MP box and making a copy of the package leaflet are not "manufacturing" activities (MDCG 2021-26), consequently the PPP will not need a MIA-GMP lincense? The QMS in place of the PPP will "control" the activities necessary for the PP.

Thanks in advance for your comments and thoughts!

BR

On the other hand, the MDR does allow a medical device manufacturer to package medicinal products in prefilled syringes and other combination products without having a drug manufacturing authorization, which is a higher-risk activity than repackaging individual containers.

In that case, the risk is controlled by notified body review with EMA consultation. A PP manufacturer doesn't have much oversight.

Ronald,

I agree with your commonsense approach to how regulating these PP depends on the intended purpose of the kit as the determining factor.  However, I am not aware of anything in the MDR or any guidance that would allow a manufacturing company (not a pharmacist or hospital) to separate individual drugs from the package in which they are approved to be marketed and market them in this manner.  

It is not that I disagree that this should be the way these are treated, but I am not sure how one "gets there" within the construct of the MDR and guidance.

I would appreciate if you could describe how this might be established.

------------------------------
Lee Leichter RAC
President
P/L Biomedical
Fort Denaud FL
United States

Original Message:
Sent: 01-May-2024 04:20
From: Ronald Boumans
Subject: Procedure Pack (PP). Article 22 & Article 16(2) with a medicinal product in the PP.

There may be a misunderstanding here: procedure packs are sets of products that have a specific medical purpose and contain at least one medical device. There are some additional specifications that exclude non-integral, copackaged drug-device combinations (I will not go into those details here). But a typical first aid kit would contain disinfectants that qualify as medicinal products. Those kits fall within Article 22. 

In short, the applicable rules all depend on the intended purpose and mode of action of each product included in the procedure pack and on that of the entire procedures set. It is important to get this right and companies should develop good insight in how this works. Reach out if you want help with that. 

Dear Anon,

You have received some good answers that have identified that a procedure pack only includes finished medical devices, and that the PP concept was not intended to address packaging drugs and medical devices together.

The preparation of a product that contains a medical device and a medicinal product is considered a medicinal product, not a medical device.  The only company that is authorized to package these together is the company that holds the MAA.  This would be considered a medicinal product packaging operation, subject to medicinal product regulations and the final product would be considered a new medicinal product presentation that would need to be represented in the PI for the medicinal product.

This could be done by a pharmacist, who is placing multiple prescribed products in a box for a single patient prescription, but not by a manufacturer for distribution.

I know that there are some products that are distributed this way in the USA where the kit includes a usually old, generic drug, but these do not even meet the definition of a convenance kit per US guidance and would need clearance by the FDA. 

I suggest that before going forward that you get the direct input from a lawyer within the EU as I think that this would not be considered legal to put this on the market as a medical device PP.

Good Luck,

------------------------------
Lee Leichter RAC
President
P/L Biomedical
Fort Denaud FL
United States

Original Message:
Sent: 29-Apr-2024 16:28
From: Armin Beck
Subject: Procedure Pack (PP). Article 22 & Article 16(2) with a medicinal product in the PP.

I sort off agree with Ronald.  A procedure pack does not include a medicinal product.  typically, it includes medical device needed to complete a procedure such as an orthopedic implants, different implants, and different tools. 

Dear community,

I'm happy to get your comments and interpretation of the applicable regulations (MDR and 2021/83/EC) for the following case:

A Procedure Pack Producer (PPP) is planning to combine a CE-mark medical device (MD) and an authorized medicinal product (MP) as part of a PP per Article 22 of the MDR. For information, the MP is marketed and registered. Per the MAH license, the MP is provided in an outer box (outer packaging) containing 10 individual MP. Each MP is presented in a pouch (immediate packaging), labelled as required per medicinal regulation. The outer box contains a single Package Leaflet (in summary: one single Package Leaflet and 10 individual MP labelled as required in an outer box). 

The PPP holds a WDA/ Wholesale Distribution Authorisation license and also a ISO 13485 QMS certificate.

When combining the MD and the MP together for the PP, the PPP will open the outer packaging of the MP, take one single 1xMP, make a copy of the MP Package Leaflet and pack it together with the 1xMD (note: all the verifications of mutual compatibility between the MD and MP have been completed as per Art 22; the PP incorporates the information for the user. In addition, when splitting up the 10 unit-box of the MP It's accepted that the condition of each individual MP is not adversely affected).

My open question to the forum is the following: the PPP, holding a WDA, is "opening the box of the MP" and making a copy of the Package Leaflet of the MP to place it as part of the PP:

1) Can I "claim the spirit" of the  MDR Article §16(2)  to consider that splitting-up the MP box and making a copy of the package leaflet are not "manufacturing" activities (MDCG 2021-26), consequently the PPP will not need a MIA-GMP lincense? The QMS in place of the PPP will "control" the activities necessary for the PP.

Thanks in advance for your comments and thoughts!

BR

Hi Anon,

no, it does not. In the case of pre-filled syringes, the leading mode of action would usually be the medicinal product and in consequece it is regulated according to 2001/83/EC, with some additional requirements for the medical device part. You would need to manufacture according to GMP.

I think Ronald is completely right: You can intergrate medicinal products (or other products) into a medical device PP (with an overall medical device intended use) and these products must comply with their respective regulation. To go back to the original question: You cannot use MDR Article 16 for repackaging these other products, they must be used as intended by the manufacturer in line with their specific regulatory requiremens. The first aid kit Ronald cited is a good example: You can integrate a disinfectant e.g. in its original bottle, but you would not be allowed to refill it into other bottles to fit within your kit.

Best regards, Christoph

On the other hand, the MDR does allow a medical device manufacturer to package medicinal products in prefilled syringes and other combination products without having a drug manufacturing authorization, which is a higher-risk activity than repackaging individual containers.

In that case, the risk is controlled by notified body review with EMA consultation. A PP manufacturer doesn't have much oversight.

Ronald,

I agree with your commonsense approach to how regulating these PP depends on the intended purpose of the kit as the determining factor.  However, I am not aware of anything in the MDR or any guidance that would allow a manufacturing company (not a pharmacist or hospital) to separate individual drugs from the package in which they are approved to be marketed and market them in this manner.  

It is not that I disagree that this should be the way these are treated, but I am not sure how one "gets there" within the construct of the MDR and guidance.

I would appreciate if you could describe how this might be established.

------------------------------
Lee Leichter RAC
President
P/L Biomedical
Fort Denaud FL
United States

Original Message:
Sent: 01-May-2024 04:20
From: Ronald Boumans
Subject: Procedure Pack (PP). Article 22 & Article 16(2) with a medicinal product in the PP.

There may be a misunderstanding here: procedure packs are sets of products that have a specific medical purpose and contain at least one medical device. There are some additional specifications that exclude non-integral, copackaged drug-device combinations (I will not go into those details here). But a typical first aid kit would contain disinfectants that qualify as medicinal products. Those kits fall within Article 22. 

In short, the applicable rules all depend on the intended purpose and mode of action of each product included in the procedure pack and on that of the entire procedures set. It is important to get this right and companies should develop good insight in how this works. Reach out if you want help with that. 

Dear Anon,

You have received some good answers that have identified that a procedure pack only includes finished medical devices, and that the PP concept was not intended to address packaging drugs and medical devices together.

The preparation of a product that contains a medical device and a medicinal product is considered a medicinal product, not a medical device.  The only company that is authorized to package these together is the company that holds the MAA.  This would be considered a medicinal product packaging operation, subject to medicinal product regulations and the final product would be considered a new medicinal product presentation that would need to be represented in the PI for the medicinal product.

This could be done by a pharmacist, who is placing multiple prescribed products in a box for a single patient prescription, but not by a manufacturer for distribution.

I know that there are some products that are distributed this way in the USA where the kit includes a usually old, generic drug, but these do not even meet the definition of a convenance kit per US guidance and would need clearance by the FDA. 

I suggest that before going forward that you get the direct input from a lawyer within the EU as I think that this would not be considered legal to put this on the market as a medical device PP.

Good Luck,

------------------------------
Lee Leichter RAC
President
P/L Biomedical
Fort Denaud FL
United States

Original Message:
Sent: 29-Apr-2024 16:28
From: Armin Beck
Subject: Procedure Pack (PP). Article 22 & Article 16(2) with a medicinal product in the PP.

I sort off agree with Ronald.  A procedure pack does not include a medicinal product.  typically, it includes medical device needed to complete a procedure such as an orthopedic implants, different implants, and different tools. 

Dear community,

I'm happy to get your comments and interpretation of the applicable regulations (MDR and 2021/83/EC) for the following case:

A Procedure Pack Producer (PPP) is planning to combine a CE-mark medical device (MD) and an authorized medicinal product (MP) as part of a PP per Article 22 of the MDR. For information, the MP is marketed and registered. Per the MAH license, the MP is provided in an outer box (outer packaging) containing 10 individual MP. Each MP is presented in a pouch (immediate packaging), labelled as required per medicinal regulation. The outer box contains a single Package Leaflet (in summary: one single Package Leaflet and 10 individual MP labelled as required in an outer box). 

The PPP holds a WDA/ Wholesale Distribution Authorisation license and also a ISO 13485 QMS certificate.

When combining the MD and the MP together for the PP, the PPP will open the outer packaging of the MP, take one single 1xMP, make a copy of the MP Package Leaflet and pack it together with the 1xMD (note: all the verifications of mutual compatibility between the MD and MP have been completed as per Art 22; the PP incorporates the information for the user. In addition, when splitting up the 10 unit-box of the MP It's accepted that the condition of each individual MP is not adversely affected).

My open question to the forum is the following: the PPP, holding a WDA, is "opening the box of the MP" and making a copy of the Package Leaflet of the MP to place it as part of the PP:

1) Can I "claim the spirit" of the  MDR Article §16(2)  to consider that splitting-up the MP box and making a copy of the package leaflet are not "manufacturing" activities (MDCG 2021-26), consequently the PPP will not need a MIA-GMP lincense? The QMS in place of the PPP will "control" the activities necessary for the PP.

Thanks in advance for your comments and thoughts!

BR

Ronald,

I agree with your commonsense approach to how regulating these PP depends on the intended purpose of the kit as the determining factor.  However, I am not aware of anything in the MDR or any guidance that would allow a manufacturing company (not a pharmacist or hospital) to separate individual drugs from the package in which they are approved to be marketed and market them in this manner.  

It is not that I disagree that this should be the way these are treated, but I am not sure how one "gets there" within the construct of the MDR and guidance.

I would appreciate if you could describe how this might be established.

There may be a misunderstanding here: procedure packs are sets of products that have a specific medical purpose and contain at least one medical device. There are some additional specifications that exclude non-integral, copackaged drug-device combinations (I will not go into those details here). But a typical first aid kit would contain disinfectants that qualify as medicinal products. Those kits fall within Article 22. 

In short, the applicable rules all depend on the intended purpose and mode of action of each product included in the procedure pack and on that of the entire procedures set. It is important to get this right and companies should develop good insight in how this works. Reach out if you want help with that. 

Dear Anon,

You have received some good answers that have identified that a procedure pack only includes finished medical devices, and that the PP concept was not intended to address packaging drugs and medical devices together.

The preparation of a product that contains a medical device and a medicinal product is considered a medicinal product, not a medical device.  The only company that is authorized to package these together is the company that holds the MAA.  This would be considered a medicinal product packaging operation, subject to medicinal product regulations and the final product would be considered a new medicinal product presentation that would need to be represented in the PI for the medicinal product.

This could be done by a pharmacist, who is placing multiple prescribed products in a box for a single patient prescription, but not by a manufacturer for distribution.

I know that there are some products that are distributed this way in the USA where the kit includes a usually old, generic drug, but these do not even meet the definition of a convenance kit per US guidance and would need clearance by the FDA. 

I suggest that before going forward that you get the direct input from a lawyer within the EU as I think that this would not be considered legal to put this on the market as a medical device PP.

Good Luck,

I sort off agree with Ronald.  A procedure pack does not include a medicinal product.  typically, it includes medical device needed to complete a procedure such as an orthopedic implants, different implants, and different tools. 

Dear community,

I'm happy to get your comments and interpretation of the applicable regulations (MDR and 2021/83/EC) for the following case:

A Procedure Pack Producer (PPP) is planning to combine a CE-mark medical device (MD) and an authorized medicinal product (MP) as part of a PP per Article 22 of the MDR. For information, the MP is marketed and registered. Per the MAH license, the MP is provided in an outer box (outer packaging) containing 10 individual MP. Each MP is presented in a pouch (immediate packaging), labelled as required per medicinal regulation. The outer box contains a single Package Leaflet (in summary: one single Package Leaflet and 10 individual MP labelled as required in an outer box). 

The PPP holds a WDA/ Wholesale Distribution Authorisation license and also a ISO 13485 QMS certificate.

When combining the MD and the MP together for the PP, the PPP will open the outer packaging of the MP, take one single 1xMP, make a copy of the MP Package Leaflet and pack it together with the 1xMD (note: all the verifications of mutual compatibility between the MD and MP have been completed as per Art 22; the PP incorporates the information for the user. In addition, when splitting up the 10 unit-box of the MP It's accepted that the condition of each individual MP is not adversely affected).

My open question to the forum is the following: the PPP, holding a WDA, is "opening the box of the MP" and making a copy of the Package Leaflet of the MP to place it as part of the PP:

1) Can I "claim the spirit" of the  MDR Article §16(2)  to consider that splitting-up the MP box and making a copy of the package leaflet are not "manufacturing" activities (MDCG 2021-26), consequently the PPP will not need a MIA-GMP lincense? The QMS in place of the PPP will "control" the activities necessary for the PP.

Thanks in advance for your comments and thoughts!

BR

There may be a misunderstanding here: procedure packs are sets of products that have a specific medical purpose and contain at least one medical device. There are some additional specifications that exclude non-integral, copackaged drug-device combinations (I will not go into those details here). But a typical first aid kit would contain disinfectants that qualify as medicinal products. Those kits fall within Article 22. 

In short, the applicable rules all depend on the intended purpose and mode of action of each product included in the procedure pack and on that of the entire procedures set. It is important to get this right and companies should develop good insight in how this works. Reach out if you want help with that. 

Dear Anon,

You have received some good answers that have identified that a procedure pack only includes finished medical devices, and that the PP concept was not intended to address packaging drugs and medical devices together.

The preparation of a product that contains a medical device and a medicinal product is considered a medicinal product, not a medical device.  The only company that is authorized to package these together is the company that holds the MAA.  This would be considered a medicinal product packaging operation, subject to medicinal product regulations and the final product would be considered a new medicinal product presentation that would need to be represented in the PI for the medicinal product.

This could be done by a pharmacist, who is placing multiple prescribed products in a box for a single patient prescription, but not by a manufacturer for distribution.

I know that there are some products that are distributed this way in the USA where the kit includes a usually old, generic drug, but these do not even meet the definition of a convenance kit per US guidance and would need clearance by the FDA. 

I suggest that before going forward that you get the direct input from a lawyer within the EU as I think that this would not be considered legal to put this on the market as a medical device PP.

Good Luck,

------------------------------
Lee Leichter RAC
President
P/L Biomedical
Fort Denaud FL
United States

Original Message:
Sent: 29-Apr-2024 16:28
From: Armin Beck
Subject: Procedure Pack (PP). Article 22 & Article 16(2) with a medicinal product in the PP.

I sort off agree with Ronald.  A procedure pack does not include a medicinal product.  typically, it includes medical device needed to complete a procedure such as an orthopedic implants, different implants, and different tools. 

Dear community,

I'm happy to get your comments and interpretation of the applicable regulations (MDR and 2021/83/EC) for the following case:

A Procedure Pack Producer (PPP) is planning to combine a CE-mark medical device (MD) and an authorized medicinal product (MP) as part of a PP per Article 22 of the MDR. For information, the MP is marketed and registered. Per the MAH license, the MP is provided in an outer box (outer packaging) containing 10 individual MP. Each MP is presented in a pouch (immediate packaging), labelled as required per medicinal regulation. The outer box contains a single Package Leaflet (in summary: one single Package Leaflet and 10 individual MP labelled as required in an outer box). 

The PPP holds a WDA/ Wholesale Distribution Authorisation license and also a ISO 13485 QMS certificate.

When combining the MD and the MP together for the PP, the PPP will open the outer packaging of the MP, take one single 1xMP, make a copy of the MP Package Leaflet and pack it together with the 1xMD (note: all the verifications of mutual compatibility between the MD and MP have been completed as per Art 22; the PP incorporates the information for the user. In addition, when splitting up the 10 unit-box of the MP It's accepted that the condition of each individual MP is not adversely affected).

My open question to the forum is the following: the PPP, holding a WDA, is "opening the box of the MP" and making a copy of the Package Leaflet of the MP to place it as part of the PP:

1) Can I "claim the spirit" of the  MDR Article §16(2)  to consider that splitting-up the MP box and making a copy of the package leaflet are not "manufacturing" activities (MDCG 2021-26), consequently the PPP will not need a MIA-GMP lincense? The QMS in place of the PPP will "control" the activities necessary for the PP.

Thanks in advance for your comments and thoughts!

BR