Regulatory Open Forum

LDTs come under the IVDR Article 5(5) which says, "With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices manufactured and used only within health institutions established in the Union, provided that all of the following conditions are met …"

Because the IVDR in general, except Annex I, doesn't apply, then PMPF in particular does not apply.

Dear Dan,
It is a bit more complicated than that. I kindly suggest that you read Richard's and my comments. 

Best,
Dirk

LDTs come under the IVDR Article 5(5) which says, "With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices manufactured and used only within health institutions established in the Union, provided that all of the following conditions are met …"

Because the IVDR in general, except Annex I, doesn't apply, then PMPF in particular does not apply.

Dirk,

It is a simple as I had stated. The complexity arises from off-topic cases such as Analyte Specific Reagents.

The initial question, paraphrased, is "Is PMPF required for an LDT under the IVDR"?  I responded "No because", and cited IVDR Article 5(5).

The term LDT, Laboratory Developed Test, is in common use in the US and other parts of the world. In the good old days, we called them home brew.

The US device regulations do not define the term LDT. Although LDTs are, in general, medical devices, and are in particular in-vitro diagnostic devices, FDA, through a policy of enforcement discretion, does not regulate them.

There is an FDA document, The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies, with a good working definition of an LDT. "Laboratory developed tests (LDTs) are the subset of IVDs intended for clinical use that are designed, manufactured, and used in a single laboratory, as opposed to other IVDs made by a conventional manufacturer and used by many laboratories".

In the US, LDTs fall under the laboratory regulations which cover conducting the tests, not their design and manufacture.

In contrast, the IVDR regulates the design and manufacture of LDTs, but not conducting the tests.

The regulation is in IVDR Art. 5(5). The head of the section says that the requirements of the IVDR do not apply, expect for Annex I, to devices manufactured and used only within health institutions established in the Union, provided the laboratory meets all of the conditions in Art. 5(5)(a) to Art. 5(5)(i). The laboratory must be part of a health institution which, following Art. 2(29) "means an organization the primary purpose of which is the care or treatment of patients or the promotion of public health".

Neither Annex I nor any of the other conditions require Annex III PMS, Annex XIII Performance Evaluation, Annex XIII Performance Studies, nor Annex III Poet-Market Performance Follow-up.

Also Art. 5(4) is not relevant. This is the case where the laboratory purchases and conducts a test from an external IVD manufacturer.

Conclusion: PMPF is not required for an LDT under the IVDR

Regards,
Dan

Dear Dan,
It is a bit more complicated than that. I kindly suggest that you read Richard's and my comments. 

Best,
Dirk

LDTs come under the IVDR Article 5(5) which says, "With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices manufactured and used only within health institutions established in the Union, provided that all of the following conditions are met …"

Because the IVDR in general, except Annex I, doesn't apply, then PMPF in particular does not apply.

Dirk,

It is a simple as I had stated. The complexity arises from off-topic cases such as Analyte Specific Reagents.

The initial question, paraphrased, is "Is PMPF required for an LDT under the IVDR"?  I responded "No because", and cited IVDR Article 5(5).

The term LDT, Laboratory Developed Test, is in common use in the US and other parts of the world. In the good old days, we called them home brew.

The US device regulations do not define the term LDT. Although LDTs are, in general, medical devices, and are in particular in-vitro diagnostic devices, FDA, through a policy of enforcement discretion, does not regulate them.

There is an FDA document, The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies, with a good working definition of an LDT. "Laboratory developed tests (LDTs) are the subset of IVDs intended for clinical use that are designed, manufactured, and used in a single laboratory, as opposed to other IVDs made by a conventional manufacturer and used by many laboratories".

In the US, LDTs fall under the laboratory regulations which cover conducting the tests, not their design and manufacture.

In contrast, the IVDR regulates the design and manufacture of LDTs, but not conducting the tests.

The regulation is in IVDR Art. 5(5). The head of the section says that the requirements of the IVDR do not apply, expect for Annex I, to devices manufactured and used only within health institutions established in the Union, provided the laboratory meets all of the conditions in Art. 5(5)(a) to Art. 5(5)(i). The laboratory must be part of a health institution which, following Art. 2(29) "means an organization the primary purpose of which is the care or treatment of patients or the promotion of public health".

Neither Annex I nor any of the other conditions require Annex III PMS, Annex XIII Performance Evaluation, Annex XIII Performance Studies, nor Annex III Poet-Market Performance Follow-up.

Also Art. 5(4) is not relevant. This is the case where the laboratory purchases and conducts a test from an external IVD manufacturer.

Conclusion: PMPF is not required for an LDT under the IVDR

Regards,
Dan

Dear Dan,
It is a bit more complicated than that. I kindly suggest that you read Richard's and my comments. 

Best,
Dirk

LDTs come under the IVDR Article 5(5) which says, "With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices manufactured and used only within health institutions established in the Union, provided that all of the following conditions are met …"

Because the IVDR in general, except Annex I, doesn't apply, then PMPF in particular does not apply.

Dirk,

It is a simple as I had stated. The complexity arises from off-topic cases such as Analyte Specific Reagents.

The initial question, paraphrased, is "Is PMPF required for an LDT under the IVDR"?  I responded "No because", and cited IVDR Article 5(5).

The term LDT, Laboratory Developed Test, is in common use in the US and other parts of the world. In the good old days, we called them home brew.

The US device regulations do not define the term LDT. Although LDTs are, in general, medical devices, and are in particular in-vitro diagnostic devices, FDA, through a policy of enforcement discretion, does not regulate them.

There is an FDA document, The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies, with a good working definition of an LDT. "Laboratory developed tests (LDTs) are the subset of IVDs intended for clinical use that are designed, manufactured, and used in a single laboratory, as opposed to other IVDs made by a conventional manufacturer and used by many laboratories".

In the US, LDTs fall under the laboratory regulations which cover conducting the tests, not their design and manufacture.

In contrast, the IVDR regulates the design and manufacture of LDTs, but not conducting the tests.

The regulation is in IVDR Art. 5(5). The head of the section says that the requirements of the IVDR do not apply, expect for Annex I, to devices manufactured and used only within health institutions established in the Union, provided the laboratory meets all of the conditions in Art. 5(5)(a) to Art. 5(5)(i). The laboratory must be part of a health institution which, following Art. 2(29) "means an organization the primary purpose of which is the care or treatment of patients or the promotion of public health".

Neither Annex I nor any of the other conditions require Annex III PMS, Annex XIII Performance Evaluation, Annex XIII Performance Studies, nor Annex III Poet-Market Performance Follow-up.

Also Art. 5(4) is not relevant. This is the case where the laboratory purchases and conducts a test from an external IVD manufacturer.

Conclusion: PMPF is not required for an LDT under the IVDR

Regards,
Dan

Dear Dan,
It is a bit more complicated than that. I kindly suggest that you read Richard's and my comments. 

Best,
Dirk

LDTs come under the IVDR Article 5(5) which says, "With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices manufactured and used only within health institutions established in the Union, provided that all of the following conditions are met …"

Because the IVDR in general, except Annex I, doesn't apply, then PMPF in particular does not apply.

Dirk,

It is a simple as I had stated. The complexity arises from off-topic cases such as Analyte Specific Reagents.

The initial question, paraphrased, is "Is PMPF required for an LDT under the IVDR"?  I responded "No because", and cited IVDR Article 5(5).

The term LDT, Laboratory Developed Test, is in common use in the US and other parts of the world. In the good old days, we called them home brew.

The US device regulations do not define the term LDT. Although LDTs are, in general, medical devices, and are in particular in-vitro diagnostic devices, FDA, through a policy of enforcement discretion, does not regulate them.

There is an FDA document, The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies, with a good working definition of an LDT. "Laboratory developed tests (LDTs) are the subset of IVDs intended for clinical use that are designed, manufactured, and used in a single laboratory, as opposed to other IVDs made by a conventional manufacturer and used by many laboratories".

In the US, LDTs fall under the laboratory regulations which cover conducting the tests, not their design and manufacture.

In contrast, the IVDR regulates the design and manufacture of LDTs, but not conducting the tests.

The regulation is in IVDR Art. 5(5). The head of the section says that the requirements of the IVDR do not apply, expect for Annex I, to devices manufactured and used only within health institutions established in the Union, provided the laboratory meets all of the conditions in Art. 5(5)(a) to Art. 5(5)(i). The laboratory must be part of a health institution which, following Art. 2(29) "means an organization the primary purpose of which is the care or treatment of patients or the promotion of public health".

Neither Annex I nor any of the other conditions require Annex III PMS, Annex XIII Performance Evaluation, Annex XIII Performance Studies, nor Annex III Poet-Market Performance Follow-up.

Also Art. 5(4) is not relevant. This is the case where the laboratory purchases and conducts a test from an external IVD manufacturer.

Conclusion: PMPF is not required for an LDT under the IVDR

Regards,
Dan

Dear Dan,
It is a bit more complicated than that. I kindly suggest that you read Richard's and my comments. 

Best,
Dirk

LDTs come under the IVDR Article 5(5) which says, "With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices manufactured and used only within health institutions established in the Union, provided that all of the following conditions are met …"

Because the IVDR in general, except Annex I, doesn't apply, then PMPF in particular does not apply.

Dear Dan,
It is a bit more complicated than that. I kindly suggest that you read Richard's and my comments. 

Best,
Dirk

LDTs come under the IVDR Article 5(5) which says, "With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices manufactured and used only within health institutions established in the Union, provided that all of the following conditions are met …"

Because the IVDR in general, except Annex I, doesn't apply, then PMPF in particular does not apply.

Dear Dan,
It is a bit more complicated than that. I kindly suggest that you read Richard's and my comments. 

Best,
Dirk

LDTs come under the IVDR Article 5(5) which says, "With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices manufactured and used only within health institutions established in the Union, provided that all of the following conditions are met …"

Because the IVDR in general, except Annex I, doesn't apply, then PMPF in particular does not apply.