Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear RAPS community, 

Can someone explain this to me?

ISO 10993-1:2018 : Section 7: Interpretation of biological data and overall biological risk assessment 

(b) the criteria for determining the acceptability of the material for the intended purpose, in line with the risk management plan


Please correct me if i am wrong:

The manufacturer qualifies the material for its intended clinical use by framing a set of requirements in line with the available regulatory standards ( if any) for the said material. Now, when the BEP is drafted, the risk assessor is expected to verify this criteria already determined by the manufacturer and laid down in the RMP? Is this understanding right?

Please comment.

Thanks in advance

Hello Anon,

Yes, essentially though I would not view it as a serial or one-after-the-after type of assessment.  This process sometimes occurs a little before each other or maybe going back and forth as the development process is proceeding.  Myself personally I would create the Risk Management Plan (RMP) maybe a little before the Biological Evaluation Plan (BEP) because the RMP is where you define the risk policy, risk acceptance, risk criteria, etc.  Therefore, depending on the type of materials for the device, some materials may meet the risk criteria while others may not.  Meaning if you develop a device with well-established materials say stainless steel, these are well characterised and known for medical device applications.  If you develop a device with a new type of nickel-cobalt (Monel) alloy for the device maybe the biological characteristics are not so well known.  When the ISO 10993 standard talks about determining the acceptability of the material, you then have already maybe gone through the RMP stating acceptability of risk and have an understanding of what may or may not be accepted for acceptability of material.  Then as mentioned, you may still go back to the RMP to adjust if during BEP development, determine the risk acceptability might be more or less.  To answer your question basically the RMP and BEP should be aligned not contradicting or having different acceptability criteria for the biological rationale or testing which would be performed.

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

Original Message:
Sent: 06-Sep-2021 08:13
From: Anonymous Member
Subject: Biological Evaluation Plan

This message was posted by a user wishing to remain anonymous

Dear RAPS community,

Can someone explain this to me?

ISO 10993-1:2018 : Section 7: Interpretation of biological data and overall biological risk assessment

(b) the criteria for determining the acceptability of the material for the intended purpose, in line with the risk management plan


Please correct me if i am wrong:

The manufacturer qualifies the material for its intended clinical use by framing a set of requirements in line with the available regulatory standards ( if any) for the said material. Now, when the BEP is drafted, the risk assessor is expected to verify this criteria already determined by the manufacturer and laid down in the RMP? Is this understanding right?

Please comment.

Thanks in advance

Original Message:
Sent: 9/7/2021 3:36:00 AM
From: Richard Vincins
Subject: RE: Biological Evaluation Plan

Hello Anon,

Yes, essentially though I would not view it as a serial or one-after-the-after type of assessment.  This process sometimes occurs a little before each other or maybe going back and forth as the development process is proceeding.  Myself personally I would create the Risk Management Plan (RMP) maybe a little before the Biological Evaluation Plan (BEP) because the RMP is where you define the risk policy, risk acceptance, risk criteria, etc.  Therefore, depending on the type of materials for the device, some materials may meet the risk criteria while others may not.  Meaning if you develop a device with well-established materials say stainless steel, these are well characterised and known for medical device applications.  If you develop a device with a new type of nickel-cobalt (Monel) alloy for the device maybe the biological characteristics are not so well known.  When the ISO 10993 standard talks about determining the acceptability of the material, you then have already maybe gone through the RMP stating acceptability of risk and have an understanding of what may or may not be accepted for acceptability of material.  Then as mentioned, you may still go back to the RMP to adjust if during BEP development, determine the risk acceptability might be more or less.  To answer your question basically the RMP and BEP should be aligned not contradicting or having different acceptability criteria for the biological rationale or testing which would be performed.

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

Original Message:
Sent: 06-Sep-2021 08:13
From: Anonymous Member
Subject: Biological Evaluation Plan

This message was posted by a user wishing to remain anonymous

Dear RAPS community,

Can someone explain this to me?

ISO 10993-1:2018 : Section 7: Interpretation of biological data and overall biological risk assessment

(b) the criteria for determining the acceptability of the material for the intended purpose, in line with the risk management plan


Please correct me if i am wrong:

The manufacturer qualifies the material for its intended clinical use by framing a set of requirements in line with the available regulatory standards ( if any) for the said material. Now, when the BEP is drafted, the risk assessor is expected to verify this criteria already determined by the manufacturer and laid down in the RMP? Is this understanding right?

Please comment.

Thanks in advance

This message was posted by a user wishing to remain anonymous

Hi Richard, 

Thank you so much. That was really helpful. 

Original Message:
Sent: 07-Sep-2021 03:35
From: Richard Vincins
Subject: Biological Evaluation Plan

Hello Anon,

Yes, essentially though I would not view it as a serial or one-after-the-after type of assessment.  This process sometimes occurs a little before each other or maybe going back and forth as the development process is proceeding.  Myself personally I would create the Risk Management Plan (RMP) maybe a little before the Biological Evaluation Plan (BEP) because the RMP is where you define the risk policy, risk acceptance, risk criteria, etc.  Therefore, depending on the type of materials for the device, some materials may meet the risk criteria while others may not.  Meaning if you develop a device with well-established materials say stainless steel, these are well characterised and known for medical device applications.  If you develop a device with a new type of nickel-cobalt (Monel) alloy for the device maybe the biological characteristics are not so well known.  When the ISO 10993 standard talks about determining the acceptability of the material, you then have already maybe gone through the RMP stating acceptability of risk and have an understanding of what may or may not be accepted for acceptability of material.  Then as mentioned, you may still go back to the RMP to adjust if during BEP development, determine the risk acceptability might be more or less.  To answer your question basically the RMP and BEP should be aligned not contradicting or having different acceptability criteria for the biological rationale or testing which would be performed.

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

Original Message:
Sent: 06-Sep-2021 08:13
From: Anonymous Member
Subject: Biological Evaluation Plan

This message was posted by a user wishing to remain anonymous

Dear RAPS community,

Can someone explain this to me?

ISO 10993-1:2018 : Section 7: Interpretation of biological data and overall biological risk assessment

(b) the criteria for determining the acceptability of the material for the intended purpose, in line with the risk management plan


Please correct me if i am wrong:

The manufacturer qualifies the material for its intended clinical use by framing a set of requirements in line with the available regulatory standards ( if any) for the said material. Now, when the BEP is drafted, the risk assessor is expected to verify this criteria already determined by the manufacturer and laid down in the RMP? Is this understanding right?

Please comment.

Thanks in advance

In ISO 14971:2019 section 4(b) the Risk Management Plan has the criteria for risk acceptability. Determine the criteria and document it in the plan before analyzing any of the hazards and estimating the initial risk. For risk evaluation is section 5, compare the estimated initial risk with the risk acceptability criteria to determine the next process step.

In ISO 10993-1:2018 section 7(b) the process is similar. Determine the criteria for the material's acceptability before determining its characteristics. Analyze the material (testing, literature, etc.) to determine the characteristics. For evaluation, compare the characteristics with the acceptability criteria to determine the next steps.

The assessor doesn't verify the acceptability criteria, it is already in the plan. The assessor evaluates the material against the criteria to determine whether the material is acceptable.

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

Original Message:
Sent: 06-Sep-2021 08:13
From: Anonymous Member
Subject: Biological Evaluation Plan

This message was posted by a user wishing to remain anonymous

Dear RAPS community,

Can someone explain this to me?

ISO 10993-1:2018 : Section 7: Interpretation of biological data and overall biological risk assessment

(b) the criteria for determining the acceptability of the material for the intended purpose, in line with the risk management plan


Please correct me if i am wrong:

The manufacturer qualifies the material for its intended clinical use by framing a set of requirements in line with the available regulatory standards ( if any) for the said material. Now, when the BEP is drafted, the risk assessor is expected to verify this criteria already determined by the manufacturer and laid down in the RMP? Is this understanding right?

Please comment.

Thanks in advance

Consideration should also be given to whether you are designing dFMEA and process / manufacturing pFMEA as part of risk management (assessment of residues in materials during production processing), where these materials should be assessed for hazards and risks as a BEP input.
further
whether the material is in a) direct contact or b) indirect contact with the patient, the user

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

Original Message:
Sent: 06-Sep-2021 08:13
From: Anonymous Member
Subject: Biological Evaluation Plan

This message was posted by a user wishing to remain anonymous

Dear RAPS community,

Can someone explain this to me?

ISO 10993-1:2018 : Section 7: Interpretation of biological data and overall biological risk assessment

(b) the criteria for determining the acceptability of the material for the intended purpose, in line with the risk management plan


Please correct me if i am wrong:

The manufacturer qualifies the material for its intended clinical use by framing a set of requirements in line with the available regulatory standards ( if any) for the said material. Now, when the BEP is drafted, the risk assessor is expected to verify this criteria already determined by the manufacturer and laid down in the RMP? Is this understanding right?

Please comment.

Thanks in advance