Regulatory Open Forum

EU MDR Article 61(10) provides criteria for waiver from the need for clinical data. Those criteria are based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between the device and the human body, the intended clinical performance, and manufacturer's claims.

Yet MDCG 2020-13 Section J instructs notified bodies to call for clinical data as part of the manufacturer's claim that clinical data aren't required.  And I similarly have an Authorized Representative (AR), one rather new to the scene, echoing this as a precondition of representation and registration for a Class I NS/NM/NRSI device. In essence, these interpretations are making a circular argument that clinical data, along with clinical evaluation of those data, are required in order to justify that clinical data aren't required.

In contrast, I've previously seen a different AR accept an Article 61(10) clinical data waiver without providing clinical data, which is what seems more in line with Article 61(10)'s intent (allowing for the reasonable notion that clinical data aren't always appropriate or needed for demonstration of conformity).  Likewise for example in other jurisdictions like the U.S. and Canada, it is routine to grant marketing authorization for low risk (and oftentimes even moderate risk) devices without clinical data.

What are your thoughts and experiences about the MDCG's and some ARs assertion that clinical data are required in order to claim that clinical data aren't required?

Hi anon,

The issue you identified may have to do with the interpretation of MDCG 2020-13. Section J of the CEAR asks for a clinical evaluation, but I do not see where it calls for clinical data as part of the justification to not use clinical data to demonstrate conformity. The CEAR is asking whether the manufacturer has searched for clinical data on their own device and similar devices. I believe it is very reasonable to complete the literature searches for the clinical evaluation as for any other device. Sometimes there are papers mentioning the device under evaluation, there may even be some clinical data. Any clinical data found may be supportive of the device's safety and performance but you would often see that it would be indirect clinical evidence (e.g. success of a procedure in which the device under evaluation was used). I have also seen people use the literature searches to demonstrate that indeed no clinical data are available and it cannot be reasonably expected that trials are done on the type of device (in other words, use searches that return no result as supportive evidence for the 61.10 strategy).

Regards,

Wiebe

EU MDR Article 61(10) provides criteria for waiver from the need for clinical data. Those criteria are based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between the device and the human body, the intended clinical performance, and manufacturer's claims.

Yet MDCG 2020-13 Section J instructs notified bodies to call for clinical data as part of the manufacturer's claim that clinical data aren't required.  And I similarly have an Authorized Representative (AR), one rather new to the scene, echoing this as a precondition of representation and registration for a Class I NS/NM/NRSI device. In essence, these interpretations are making a circular argument that clinical data, along with clinical evaluation of those data, are required in order to justify that clinical data aren't required.

In contrast, I've previously seen a different AR accept an Article 61(10) clinical data waiver without providing clinical data, which is what seems more in line with Article 61(10)'s intent (allowing for the reasonable notion that clinical data aren't always appropriate or needed for demonstration of conformity).  Likewise for example in other jurisdictions like the U.S. and Canada, it is routine to grant marketing authorization for low risk (and oftentimes even moderate risk) devices without clinical data.

What are your thoughts and experiences about the MDCG's and some ARs assertion that clinical data are required in order to claim that clinical data aren't required?

Hi anon,

The issue you identified may have to do with the interpretation of MDCG 2020-13. Section J of the CEAR asks for a clinical evaluation, but I do not see where it calls for clinical data as part of the justification to not use clinical data to demonstrate conformity. The CEAR is asking whether the manufacturer has searched for clinical data on their own device and similar devices. I believe it is very reasonable to complete the literature searches for the clinical evaluation as for any other device. Sometimes there are papers mentioning the device under evaluation, there may even be some clinical data. Any clinical data found may be supportive of the device's safety and performance but you would often see that it would be indirect clinical evidence (e.g. success of a procedure in which the device under evaluation was used). I have also seen people use the literature searches to demonstrate that indeed no clinical data are available and it cannot be reasonably expected that trials are done on the type of device (in other words, use searches that return no result as supportive evidence for the 61.10 strategy).

Regards,

Wiebe

EU MDR Article 61(10) provides criteria for waiver from the need for clinical data. Those criteria are based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between the device and the human body, the intended clinical performance, and manufacturer's claims.

Yet MDCG 2020-13 Section J instructs notified bodies to call for clinical data as part of the manufacturer's claim that clinical data aren't required.  And I similarly have an Authorized Representative (AR), one rather new to the scene, echoing this as a precondition of representation and registration for a Class I NS/NM/NRSI device. In essence, these interpretations are making a circular argument that clinical data, along with clinical evaluation of those data, are required in order to justify that clinical data aren't required.

In contrast, I've previously seen a different AR accept an Article 61(10) clinical data waiver without providing clinical data, which is what seems more in line with Article 61(10)'s intent (allowing for the reasonable notion that clinical data aren't always appropriate or needed for demonstration of conformity).  Likewise for example in other jurisdictions like the U.S. and Canada, it is routine to grant marketing authorization for low risk (and oftentimes even moderate risk) devices without clinical data.

What are your thoughts and experiences about the MDCG's and some ARs assertion that clinical data are required in order to claim that clinical data aren't required?

Thank you, Wiebe for your reply.  Your narrative, "...MDCG 2020-13. Section J of the CEAR asks for a clinical evaluation, but I do not see where it calls for clinical data as part of the justification to not use clinical data to demonstrate conformity..." perfectly demonstrates the dichotomous circularity of the issue:

"Clinical evaluation" [EU MDR Article 2(44)] fundamentally means a systematic and planned process to continuously generate, collect, analyze and assess the clinical data. Consequently, MDCG 2020-13 Section J's call for clinical evaluation is in effect a call for clinical data.

Similarly, Section J's questions:

• "Has any available clinical data for the device or an equivalent device been searched for and/or identified by the manufacturer?", and
• "...was the identified clinical data integrated in the clinical evaluation", and
• "Is clinical data available for similar devices, does this provide information with relevant to the safety and performance of the device under evaluation", and
• "Has the manufacturer conducted an appropriate search of scientific literature?",

are all calls for clinical data and clinical evaluation.  These clinical data and evaluation requirements placed upon the manufacturer's justification for not needing clinical data again raise the dichotomous nature of the way this is being handled for Europe's Union.  I also note that this dichotomous approach is not new, as it was born out of MEDDEV 2.7/1 revision 4.

In essence, it seems that clinical data and evaluation are always required for Europe Union's even when they aren't actually necessary for demonstrating conformity with the general safety and performance requirements.  I hope that this paradigm will be reconsidered in realization that burdensome clinical data and evaluation aren't always needed or sensible for the purposes of general safety and performance requirements.

Hi anon,

The issue you identified may have to do with the interpretation of MDCG 2020-13. Section J of the CEAR asks for a clinical evaluation, but I do not see where it calls for clinical data as part of the justification to not use clinical data to demonstrate conformity. The CEAR is asking whether the manufacturer has searched for clinical data on their own device and similar devices. I believe it is very reasonable to complete the literature searches for the clinical evaluation as for any other device. Sometimes there are papers mentioning the device under evaluation, there may even be some clinical data. Any clinical data found may be supportive of the device's safety and performance but you would often see that it would be indirect clinical evidence (e.g. success of a procedure in which the device under evaluation was used). I have also seen people use the literature searches to demonstrate that indeed no clinical data are available and it cannot be reasonably expected that trials are done on the type of device (in other words, use searches that return no result as supportive evidence for the 61.10 strategy).

Regards,

Wiebe

EU MDR Article 61(10) provides criteria for waiver from the need for clinical data. Those criteria are based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between the device and the human body, the intended clinical performance, and manufacturer's claims.

Yet MDCG 2020-13 Section J instructs notified bodies to call for clinical data as part of the manufacturer's claim that clinical data aren't required.  And I similarly have an Authorized Representative (AR), one rather new to the scene, echoing this as a precondition of representation and registration for a Class I NS/NM/NRSI device. In essence, these interpretations are making a circular argument that clinical data, along with clinical evaluation of those data, are required in order to justify that clinical data aren't required.

In contrast, I've previously seen a different AR accept an Article 61(10) clinical data waiver without providing clinical data, which is what seems more in line with Article 61(10)'s intent (allowing for the reasonable notion that clinical data aren't always appropriate or needed for demonstration of conformity).  Likewise for example in other jurisdictions like the U.S. and Canada, it is routine to grant marketing authorization for low risk (and oftentimes even moderate risk) devices without clinical data.

What are your thoughts and experiences about the MDCG's and some ARs assertion that clinical data are required in order to claim that clinical data aren't required?

Hi Kevin,

Thanks for your insightful comment. I agree with you that there are inconsistencies in the way clinical data and evaluation are required. However, I do think that it makes sense to conduct a clinical evaluation for every medical device, even if the device does not require clinical data. The clinical evaluation is not only used to present and evaluate clinical data, but also to establish the state of the art, demonstrate that various sources were examined for clinical data (a null result is still a result), and to document the strategy for proving clinical safety and performance even if it is decided that clinical data are not deemed appropriate. I believe this is in line with the guidance provided by MDCG 2020-6 and MDCG 2020-5, which explain the purpose and scope of clinical evaluation and how it should be performed and documented. Perhaps the definition of clinical evaluation, which as you rightfully pointed out directly calls for clinical data (i.e. safety/performance data generated from the use of a device) should be broadened to include other data proving the safety and performance of a device.

------------------------------
Wiebe Postma
Vierpolders
Netherlands

Original Message:
Sent: 13-Sep-2023 11:35
From: Kevin Randall
Subject: EU MDR Article 61(10) waiver from clinical data

Thank you, Wiebe for your reply.  Your narrative, "...MDCG 2020-13. Section J of the CEAR asks for a clinical evaluation, but I do not see where it calls for clinical data as part of the justification to not use clinical data to demonstrate conformity..." perfectly demonstrates the dichotomous circularity of the issue:

"Clinical evaluation" [EU MDR Article 2(44)] fundamentally means a systematic and planned process to continuously generate, collect, analyze and assess the clinical data. Consequently, MDCG 2020-13 Section J's call for clinical evaluation is in effect a call for clinical data.

Similarly, Section J's questions:

• "Has any available clinical data for the device or an equivalent device been searched for and/or identified by the manufacturer?", and
• "...was the identified clinical data integrated in the clinical evaluation", and
• "Is clinical data available for similar devices, does this provide information with relevant to the safety and performance of the device under evaluation", and
• "Has the manufacturer conducted an appropriate search of scientific literature?",

are all calls for clinical data and clinical evaluation.  These clinical data and evaluation requirements placed upon the manufacturer's justification for not needing clinical data again raise the dichotomous nature of the way this is being handled for Europe's Union.  I also note that this dichotomous approach is not new, as it was born out of MEDDEV 2.7/1 revision 4.

In essence, it seems that clinical data and evaluation are always required for Europe Union's even when they aren't actually necessary for demonstrating conformity with the general safety and performance requirements.  I hope that this paradigm will be reconsidered in realization that burdensome clinical data and evaluation aren't always needed or sensible for the purposes of general safety and performance requirements.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 13-Sep-2023 03:09
From: Wiebe Postma
Subject: EU MDR Article 61(10) waiver from clinical data

Hi anon,

The issue you identified may have to do with the interpretation of MDCG 2020-13. Section J of the CEAR asks for a clinical evaluation, but I do not see where it calls for clinical data as part of the justification to not use clinical data to demonstrate conformity. The CEAR is asking whether the manufacturer has searched for clinical data on their own device and similar devices. I believe it is very reasonable to complete the literature searches for the clinical evaluation as for any other device. Sometimes there are papers mentioning the device under evaluation, there may even be some clinical data. Any clinical data found may be supportive of the device's safety and performance but you would often see that it would be indirect clinical evidence (e.g. success of a procedure in which the device under evaluation was used). I have also seen people use the literature searches to demonstrate that indeed no clinical data are available and it cannot be reasonably expected that trials are done on the type of device (in other words, use searches that return no result as supportive evidence for the 61.10 strategy).

Regards,

Wiebe

------------------------------
Wiebe Postma
Vierpolders
Netherlands

Original Message:
Sent: 11-Sep-2023 16:23
From: Anonymous Member
Subject: EU MDR Article 61(10) waiver from clinical data

This message was posted by a user wishing to remain anonymous

EU MDR Article 61(10) provides criteria for waiver from the need for clinical data. Those criteria are based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between the device and the human body, the intended clinical performance, and manufacturer's claims.

Yet MDCG 2020-13 Section J instructs notified bodies to call for clinical data as part of the manufacturer's claim that clinical data aren't required.  And I similarly have an Authorized Representative (AR), one rather new to the scene, echoing this as a precondition of representation and registration for a Class I NS/NM/NRSI device. In essence, these interpretations are making a circular argument that clinical data, along with clinical evaluation of those data, are required in order to justify that clinical data aren't required.

In contrast, I've previously seen a different AR accept an Article 61(10) clinical data waiver without providing clinical data, which is what seems more in line with Article 61(10)'s intent (allowing for the reasonable notion that clinical data aren't always appropriate or needed for demonstration of conformity).  Likewise for example in other jurisdictions like the U.S. and Canada, it is routine to grant marketing authorization for low risk (and oftentimes even moderate risk) devices without clinical data.

What are your thoughts and experiences about the MDCG's and some ARs assertion that clinical data are required in order to claim that clinical data aren't required?

EU MDR Article 61(10) provides criteria for waiver from the need for clinical data. Those criteria are based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between the device and the human body, the intended clinical performance, and manufacturer's claims.

Yet MDCG 2020-13 Section J instructs notified bodies to call for clinical data as part of the manufacturer's claim that clinical data aren't required.  And I similarly have an Authorized Representative (AR), one rather new to the scene, echoing this as a precondition of representation and registration for a Class I NS/NM/NRSI device. In essence, these interpretations are making a circular argument that clinical data, along with clinical evaluation of those data, are required in order to justify that clinical data aren't required.

In contrast, I've previously seen a different AR accept an Article 61(10) clinical data waiver without providing clinical data, which is what seems more in line with Article 61(10)'s intent (allowing for the reasonable notion that clinical data aren't always appropriate or needed for demonstration of conformity).  Likewise for example in other jurisdictions like the U.S. and Canada, it is routine to grant marketing authorization for low risk (and oftentimes even moderate risk) devices without clinical data.

What are your thoughts and experiences about the MDCG's and some ARs assertion that clinical data are required in order to claim that clinical data aren't required?

EU MDR Article 61(10) provides criteria for waiver from the need for clinical data. Those criteria are based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between the device and the human body, the intended clinical performance, and manufacturer's claims.

Yet MDCG 2020-13 Section J instructs notified bodies to call for clinical data as part of the manufacturer's claim that clinical data aren't required.  And I similarly have an Authorized Representative (AR), one rather new to the scene, echoing this as a precondition of representation and registration for a Class I NS/NM/NRSI device. In essence, these interpretations are making a circular argument that clinical data, along with clinical evaluation of those data, are required in order to justify that clinical data aren't required.

In contrast, I've previously seen a different AR accept an Article 61(10) clinical data waiver without providing clinical data, which is what seems more in line with Article 61(10)'s intent (allowing for the reasonable notion that clinical data aren't always appropriate or needed for demonstration of conformity).  Likewise for example in other jurisdictions like the U.S. and Canada, it is routine to grant marketing authorization for low risk (and oftentimes even moderate risk) devices without clinical data.

What are your thoughts and experiences about the MDCG's and some ARs assertion that clinical data are required in order to claim that clinical data aren't required?

In my view this is a rather simple issue: there is a difference in the meaning of clinical data and the clinical evaluation. Clinical data, see definition 48 of the MDR, is about data coming from the use of the device. The clinical evaluation is about the acceptability of risks when weighed against the clinical benefits. This does not necessarily have to depend on clinical data. For example, an accessory may use validation testing to demonstrate that the claimed performance is delivered. That test result can be used in the clinical evaluation of this accessory. 

This is something I would typically expect to see in the regulatory strategy report. By providing such information to any reviewer, they either have the discussion then, or you manage their expectations in such a way that they accept this principle. Regulatory strategy: make sure the problems are addressed right at the start.

------------------------------
Ronald Boumans
MDR Expert
Super PRRC
Netherlands

Original Message:
Sent: 11-Sep-2023 16:23
From: Anonymous Member
Subject: EU MDR Article 61(10) waiver from clinical data

This message was posted by a user wishing to remain anonymous

EU MDR Article 61(10) provides criteria for waiver from the need for clinical data. Those criteria are based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between the device and the human body, the intended clinical performance, and manufacturer's claims.

Yet MDCG 2020-13 Section J instructs notified bodies to call for clinical data as part of the manufacturer's claim that clinical data aren't required.  And I similarly have an Authorized Representative (AR), one rather new to the scene, echoing this as a precondition of representation and registration for a Class I NS/NM/NRSI device. In essence, these interpretations are making a circular argument that clinical data, along with clinical evaluation of those data, are required in order to justify that clinical data aren't required.

In contrast, I've previously seen a different AR accept an Article 61(10) clinical data waiver without providing clinical data, which is what seems more in line with Article 61(10)'s intent (allowing for the reasonable notion that clinical data aren't always appropriate or needed for demonstration of conformity).  Likewise for example in other jurisdictions like the U.S. and Canada, it is routine to grant marketing authorization for low risk (and oftentimes even moderate risk) devices without clinical data.

What are your thoughts and experiences about the MDCG's and some ARs assertion that clinical data are required in order to claim that clinical data aren't required?

Pursuant to the aforesaid definition of "clinical evaluation" in Article 2(44), the legislative intent is that clinical evaluation fundamentally and necessarily involves evaluation of "clinical data".  And "clinical data" is not a term that is eligible for our subjective interpretations; instead, it has a longstanding, standardized, and now legislative, meaning [definition in Article 2(48)].  Legislatively speaking, "clinical data" does not include non-clinical data.  An evaluation of non-clinical data is not clinical evaluation, but rather is non-clinical evaluation that may consist of a variety of non-clinical methods pursuant to Annex II.4(b) and Annex II.6.  Accordingly, if we include an evaluation of non-clinical validation data (or other non-clinical data) under the guise of clinical evaluation, then we would be out of step with the legislative intent of Europe's MDR for clinical evaluation.  Moreover, Europe's MDR has been a burdensome leap for the device industry and regulators alike. Magnifying that burden by deploying clinical evaluation (itself a considerable burden all its own) for the assessment of non-clinical data is not only incongruous with legislation, but also drives up regulatory costs considerably.

In my view this is a rather simple issue: there is a difference in the meaning of clinical data and the clinical evaluation. Clinical data, see definition 48 of the MDR, is about data coming from the use of the device. The clinical evaluation is about the acceptability of risks when weighed against the clinical benefits. This does not necessarily have to depend on clinical data. For example, an accessory may use validation testing to demonstrate that the claimed performance is delivered. That test result can be used in the clinical evaluation of this accessory. 

This is something I would typically expect to see in the regulatory strategy report. By providing such information to any reviewer, they either have the discussion then, or you manage their expectations in such a way that they accept this principle. Regulatory strategy: make sure the problems are addressed right at the start.

------------------------------
Ronald Boumans
MDR Expert
Super PRRC
Netherlands

Original Message:
Sent: 11-Sep-2023 16:23
From: Anonymous Member
Subject: EU MDR Article 61(10) waiver from clinical data

This message was posted by a user wishing to remain anonymous

EU MDR Article 61(10) provides criteria for waiver from the need for clinical data. Those criteria are based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between the device and the human body, the intended clinical performance, and manufacturer's claims.

Yet MDCG 2020-13 Section J instructs notified bodies to call for clinical data as part of the manufacturer's claim that clinical data aren't required.  And I similarly have an Authorized Representative (AR), one rather new to the scene, echoing this as a precondition of representation and registration for a Class I NS/NM/NRSI device. In essence, these interpretations are making a circular argument that clinical data, along with clinical evaluation of those data, are required in order to justify that clinical data aren't required.

In contrast, I've previously seen a different AR accept an Article 61(10) clinical data waiver without providing clinical data, which is what seems more in line with Article 61(10)'s intent (allowing for the reasonable notion that clinical data aren't always appropriate or needed for demonstration of conformity).  Likewise for example in other jurisdictions like the U.S. and Canada, it is routine to grant marketing authorization for low risk (and oftentimes even moderate risk) devices without clinical data.

What are your thoughts and experiences about the MDCG's and some ARs assertion that clinical data are required in order to claim that clinical data aren't required?

Dear Everyone,

I hope this message finds you well. I wanted to share some thoughts on our ongoing discussion, particularly regarding the interpretation of MDCG guidelines.

First and foremost, I'd like to express my enthusiasm for MDCG 2020-13 J, as it provides the necessary guidance we need. Without this reference, we might encounter situations where notified bodies could question the applicability of Article 61.10 for medical devices. This is a pivotal concern because, in general, medical devices with potential risks and hopefully clinical benefits require a robust clinical evaluation. However, under the guidance, we have the means to justify that further "clinical data is not deemed appropriate."

The MDR explicitly mentions when "clinical data is not deemed appropriate." Two scenarios come to mind:

1.     The device is not a medical device, which implies that obtaining clinical data is simply impossible due to the absence of clinical benefits. This category typically includes accessories, especially those that do not interact with the patient. Accessories that do interact with the patient may need to follow the suggestions outlined in Article 61.9 regarding required data.

2.     In cases where the device is indeed a medical device, there may be situations where it's not deemed appropriate to obtain additional clinical data. Here, Article 61.6(b) can be a valuable resource, particularly when dealing with well-established technologies.

It seems that MDCG 2020-13 predominantly refers to the second scenario, strongly suggesting that it's appropriate for medical devices to apply Article 61.10. This is indeed a valuable reference, and I believe we should celebrate its existence.

For scenario one, conducting a clinical investigation is not even be ethically justifiable, and a clinical evaluation and Post-Market Clinical Follow-up (PMCF) should not be necessary. In contrast, for scenario two, while a clinical investigation might not be mandatory, it might still be essential to continue the clinical evaluation process. And certainly Post-Market Surveillance (PMS) is sufficient instead of a PMCF. However, these decisions should be made within the context of a thorough evaluation that indeed the conformity with the general safety and performance requirements is given.

In conclusion, it's worth considering that the Commission could significantly assist in this matter by implementing Common Specifications (CS) to establish standardized clinical data requirements for all devices, particularly those involving well-established products. This would eliminate the need for manufacturers to speculate about what constitutes sufficient clinical data, as everyone would adhere to the same principles. I hope that the MDCG will prioritize this direction, and manufacturers could potentially influence this positive shift, ultimately resolving a substantial issue in our industry.

Warm regards,

------------------------------
Ludger Moeller
President, MDSS GmbH
l.moeller@mdssar.com

Original Message:
Sent: 18-Sep-2023 12:05
From: Kevin Randall
Subject: EU MDR Article 61(10) waiver from clinical data

Pursuant to the aforesaid definition of "clinical evaluation" in Article 2(44), the legislative intent is that clinical evaluation fundamentally and necessarily involves evaluation of "clinical data".  And "clinical data" is not a term that is eligible for our subjective interpretations; instead, it has a longstanding, standardized, and now legislative, meaning [definition in Article 2(48)].  Legislatively speaking, "clinical data" does not include non-clinical data.  An evaluation of non-clinical data is not clinical evaluation, but rather is non-clinical evaluation that may consist of a variety of non-clinical methods pursuant to Annex II.4(b) and Annex II.6.  Accordingly, if we include an evaluation of non-clinical validation data (or other non-clinical data) under the guise of clinical evaluation, then we would be out of step with the legislative intent of Europe's MDR for clinical evaluation.  Moreover, Europe's MDR has been a burdensome leap for the device industry and regulators alike. Magnifying that burden by deploying clinical evaluation (itself a considerable burden all its own) for the assessment of non-clinical data is not only incongruous with legislation, but also drives up regulatory costs considerably.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 17-Sep-2023 04:56
From: Ronald Boumans
Subject: EU MDR Article 61(10) waiver from clinical data

In my view this is a rather simple issue: there is a difference in the meaning of clinical data and the clinical evaluation. Clinical data, see definition 48 of the MDR, is about data coming from the use of the device. The clinical evaluation is about the acceptability of risks when weighed against the clinical benefits. This does not necessarily have to depend on clinical data. For example, an accessory may use validation testing to demonstrate that the claimed performance is delivered. That test result can be used in the clinical evaluation of this accessory. 

This is something I would typically expect to see in the regulatory strategy report. By providing such information to any reviewer, they either have the discussion then, or you manage their expectations in such a way that they accept this principle. Regulatory strategy: make sure the problems are addressed right at the start.

------------------------------
Ronald Boumans
MDR Expert
Super PRRC
Netherlands

Original Message:
Sent: 11-Sep-2023 16:23
From: Anonymous Member
Subject: EU MDR Article 61(10) waiver from clinical data

This message was posted by a user wishing to remain anonymous

EU MDR Article 61(10) provides criteria for waiver from the need for clinical data. Those criteria are based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between the device and the human body, the intended clinical performance, and manufacturer's claims.

Yet MDCG 2020-13 Section J instructs notified bodies to call for clinical data as part of the manufacturer's claim that clinical data aren't required.  And I similarly have an Authorized Representative (AR), one rather new to the scene, echoing this as a precondition of representation and registration for a Class I NS/NM/NRSI device. In essence, these interpretations are making a circular argument that clinical data, along with clinical evaluation of those data, are required in order to justify that clinical data aren't required.

In contrast, I've previously seen a different AR accept an Article 61(10) clinical data waiver without providing clinical data, which is what seems more in line with Article 61(10)'s intent (allowing for the reasonable notion that clinical data aren't always appropriate or needed for demonstration of conformity).  Likewise for example in other jurisdictions like the U.S. and Canada, it is routine to grant marketing authorization for low risk (and oftentimes even moderate risk) devices without clinical data.

What are your thoughts and experiences about the MDCG's and some ARs assertion that clinical data are required in order to claim that clinical data aren't required?

EU MDR Article 61(10) provides criteria for waiver from the need for clinical data. Those criteria are based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between the device and the human body, the intended clinical performance, and manufacturer's claims.

Yet MDCG 2020-13 Section J instructs notified bodies to call for clinical data as part of the manufacturer's claim that clinical data aren't required.  And I similarly have an Authorized Representative (AR), one rather new to the scene, echoing this as a precondition of representation and registration for a Class I NS/NM/NRSI device. In essence, these interpretations are making a circular argument that clinical data, along with clinical evaluation of those data, are required in order to justify that clinical data aren't required.

In contrast, I've previously seen a different AR accept an Article 61(10) clinical data waiver without providing clinical data, which is what seems more in line with Article 61(10)'s intent (allowing for the reasonable notion that clinical data aren't always appropriate or needed for demonstration of conformity).  Likewise for example in other jurisdictions like the U.S. and Canada, it is routine to grant marketing authorization for low risk (and oftentimes even moderate risk) devices without clinical data.

What are your thoughts and experiences about the MDCG's and some ARs assertion that clinical data are required in order to claim that clinical data aren't required?

EU MDR Article 61(10) provides criteria for waiver from the need for clinical data. Those criteria are based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between the device and the human body, the intended clinical performance, and manufacturer's claims.

Yet MDCG 2020-13 Section J instructs notified bodies to call for clinical data as part of the manufacturer's claim that clinical data aren't required.  And I similarly have an Authorized Representative (AR), one rather new to the scene, echoing this as a precondition of representation and registration for a Class I NS/NM/NRSI device. In essence, these interpretations are making a circular argument that clinical data, along with clinical evaluation of those data, are required in order to justify that clinical data aren't required.

In contrast, I've previously seen a different AR accept an Article 61(10) clinical data waiver without providing clinical data, which is what seems more in line with Article 61(10)'s intent (allowing for the reasonable notion that clinical data aren't always appropriate or needed for demonstration of conformity).  Likewise for example in other jurisdictions like the U.S. and Canada, it is routine to grant marketing authorization for low risk (and oftentimes even moderate risk) devices without clinical data.

What are your thoughts and experiences about the MDCG's and some ARs assertion that clinical data are required in order to claim that clinical data aren't required?