Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi,

We have an orthopaedic implant which is currently CE marked. However, we also manufacture patient specific or custom made version of this device. Is there a way to get these version included as part of our existing CE certificate by updating the technical file? We plan to launch patient-specific or custom made version in Australia but our sponsor is asking for CE marking for both ARTG entry with the TGA and reimbursement for prosthesis list.

Any guidance will be greatly appreciated.

Thank you.

Hello,

I would not confuse patient specific and custom made terminology as they do mean different aspects (at least to me they do).  You can have a type of device that is special order, patient specific, specified configuration, etc., these patient specific devices have the same indications for use, same materials, same manufacturing process, same sterility, etc. etc., the only different is the actual device might be slightly different from one to another.  I am sure you are quite aware of this as an orthopaedic implant could be machined to a specific length, number of holes, based on the patient specified needs (usually from the physician).  A custom made device is only one of a kind where the indications for use, the manufacturing, the use of the device is for a specific unmet need for a physician (and the patient).  A custom made device is usually quantity of less than 5 and very specific from a clinical perspective.

It should be noted the regulatory pathway for patient specific/special order devices is completely different from custom made devices.

You might want to have another discussion with your Australian Sponsor about the device (and keep the word custom out of the conversation).  A device CE Mark can encompass these patient specific type of devices, how this is documented in your Technical Documentation might need to be a bit more creative, such as identifying ranges, configurations, or different types of versions produced under this product family.  This is the key, your orthopaedic implant in the Technical Documentation should be a product family with the same indications for use, same materials, same operation, same mode of action, same technology, etc.  I have worked on other Tech Doc files for prosthetic devices and we just specified ranges on different attributes, because on that instance was used for a patient lower extremity, but as you can imagine all humans are not the same height and length of legs !  We did make them specific to the patient based on their individual measurements, but the indications for use was the same, the materials were the same, the manufacturing process was the same, in our technical documentation we just showed the length, circumference, etc. was from X to Y.

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

Original Message:
Sent: 14-May-2020 10:06
From: Anonymous Member
Subject: CE Marking for Custom-made or Patient Matched or Patient Specific Implant for Australia

This message was posted by a user wishing to remain anonymous

Hi,

We have an orthopaedic implant which is currently CE marked. However, we also manufacture patient specific or custom made version of this device. Is there a way to get these version included as part of our existing CE certificate by updating the technical file? We plan to launch patient-specific or custom made version in Australia but our sponsor is asking for CE marking for both ARTG entry with the TGA and reimbursement for prosthesis list.

Any guidance will be greatly appreciated.

Thank you.

This message was posted by a user wishing to remain anonymous

Hi Richard,

Is there a definition or reference in EU guidance or MDR/MDD where difference between patient specific implant and custom made device requirements are explained as you have described? 

Where is the requirement for patient specific implant to be CE marked has been provided?

Thank you.
Original Message:
Sent: 15-May-2020 06:29
From: Richard Vincins
Subject: CE Marking for Custom-made or Patient Matched or Patient Specific Implant for Australia

Hello,

I would not confuse patient specific and custom made terminology as they do mean different aspects (at least to me they do).  You can have a type of device that is special order, patient specific, specified configuration, etc., these patient specific devices have the same indications for use, same materials, same manufacturing process, same sterility, etc. etc., the only different is the actual device might be slightly different from one to another.  I am sure you are quite aware of this as an orthopaedic implant could be machined to a specific length, number of holes, based on the patient specified needs (usually from the physician).  A custom made device is only one of a kind where the indications for use, the manufacturing, the use of the device is for a specific unmet need for a physician (and the patient).  A custom made device is usually quantity of less than 5 and very specific from a clinical perspective.

It should be noted the regulatory pathway for patient specific/special order devices is completely different from custom made devices.

You might want to have another discussion with your Australian Sponsor about the device (and keep the word custom out of the conversation).  A device CE Mark can encompass these patient specific type of devices, how this is documented in your Technical Documentation might need to be a bit more creative, such as identifying ranges, configurations, or different types of versions produced under this product family.  This is the key, your orthopaedic implant in the Technical Documentation should be a product family with the same indications for use, same materials, same operation, same mode of action, same technology, etc.  I have worked on other Tech Doc files for prosthetic devices and we just specified ranges on different attributes, because on that instance was used for a patient lower extremity, but as you can imagine all humans are not the same height and length of legs !  We did make them specific to the patient based on their individual measurements, but the indications for use was the same, the materials were the same, the manufacturing process was the same, in our technical documentation we just showed the length, circumference, etc. was from X to Y.

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

Original Message:
Sent: 14-May-2020 10:06
From: Anonymous Member
Subject: CE Marking for Custom-made or Patient Matched or Patient Specific Implant for Australia

This message was posted by a user wishing to remain anonymous

Hi,

We have an orthopaedic implant which is currently CE marked. However, we also manufacture patient specific or custom made version of this device. Is there a way to get these version included as part of our existing CE certificate by updating the technical file? We plan to launch patient-specific or custom made version in Australia but our sponsor is asking for CE marking for both ARTG entry with the TGA and reimbursement for prosthesis list.

Any guidance will be greatly appreciated.

Thank you.

Hi there,

Actually there is - thankfully the EU MDR included a definition for a custom device.  And to me this is quite clear that "mass produced" products similar are not considered custom devices.

'custom-made device' means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs. However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices.

The meaning behind adapted to meet specific requirements is the special order or patient specific needs and clearly says shall not be considered a custom-made device.

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

Original Message:
Sent: 18-May-2020 10:56
From: Anonymous Member
Subject: CE Marking for Custom-made or Patient Matched or Patient Specific Implant for Australia

This message was posted by a user wishing to remain anonymous

Hi Richard,

Is there a definition or reference in EU guidance or MDR/MDD where difference between patient specific implant and custom made device requirements are explained as you have described?

Where is the requirement for patient specific implant to be CE marked has been provided?

Thank you.
Original Message:
Sent: 15-May-2020 06:29
From: Richard Vincins
Subject: CE Marking for Custom-made or Patient Matched or Patient Specific Implant for Australia

Hello,

I would not confuse patient specific and custom made terminology as they do mean different aspects (at least to me they do).  You can have a type of device that is special order, patient specific, specified configuration, etc., these patient specific devices have the same indications for use, same materials, same manufacturing process, same sterility, etc. etc., the only different is the actual device might be slightly different from one to another.  I am sure you are quite aware of this as an orthopaedic implant could be machined to a specific length, number of holes, based on the patient specified needs (usually from the physician).  A custom made device is only one of a kind where the indications for use, the manufacturing, the use of the device is for a specific unmet need for a physician (and the patient).  A custom made device is usually quantity of less than 5 and very specific from a clinical perspective.

It should be noted the regulatory pathway for patient specific/special order devices is completely different from custom made devices.

You might want to have another discussion with your Australian Sponsor about the device (and keep the word custom out of the conversation).  A device CE Mark can encompass these patient specific type of devices, how this is documented in your Technical Documentation might need to be a bit more creative, such as identifying ranges, configurations, or different types of versions produced under this product family.  This is the key, your orthopaedic implant in the Technical Documentation should be a product family with the same indications for use, same materials, same operation, same mode of action, same technology, etc.  I have worked on other Tech Doc files for prosthetic devices and we just specified ranges on different attributes, because on that instance was used for a patient lower extremity, but as you can imagine all humans are not the same height and length of legs !  We did make them specific to the patient based on their individual measurements, but the indications for use was the same, the materials were the same, the manufacturing process was the same, in our technical documentation we just showed the length, circumference, etc. was from X to Y.

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

Original Message:
Sent: 14-May-2020 10:06
From: Anonymous Member
Subject: CE Marking for Custom-made or Patient Matched or Patient Specific Implant for Australia

This message was posted by a user wishing to remain anonymous

Hi,

We have an orthopaedic implant which is currently CE marked. However, we also manufacture patient specific or custom made version of this device. Is there a way to get these version included as part of our existing CE certificate by updating the technical file? We plan to launch patient-specific or custom made version in Australia but our sponsor is asking for CE marking for both ARTG entry with the TGA and reimbursement for prosthesis list.

Any guidance will be greatly appreciated.

Thank you.