CEP requirements in MEDDEV 2.7/1, rev 4 and MDR - Are all MEDDEV requirements still applicable?

[med_cert]

1. There are some differences in CEP requirements in MEDDEV 2.7/1, rev 4 and MDR. Are all MEDDEV requirements still applicable?

2. MDR Annex XIV... what exactly means "an indicative list and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and for the intended purpose or purposes of the device"? Does anyone has any example?

 

[Ronen E]

There will probably be a MEDDEV 2.7/1 rev 5 aligned with the MDR. At the moment there's no official clinical evaluation guidance for MDR.

 

[Marcelo]

1. There are some differences in CEP requirements in MEDDEV 2.7/1, rev 4 and MDR. Are all MEDDEV requirements still applicable?

Not as Ronen mentioned, the MEDDEV will need to be updated 8this is a high priority action for the implementation of the MDR, as detailed in the implementation plan).

2. MDR Annex XIV... what exactly means "an indicative list and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and for the intended purpose or purposes of the device"? Does anyone has any example?

This means which device parameters will be used as part of the state of the art and benefit-risk ratio evaluation. This is because most manufacturers use the concept of state of the art, but too generally. This requires that you define which parameters of the device you are verifying the state of the art with.

 

[SKM.Sunil]

2. MDR Annex XIV... what exactly means "an indicative list and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and for the intended purpose or purposes of the device"? Does anyone has any example?

This means which device parameters will be used as part of the state of the art and benefit-risk ratio evaluation. This is because most manufacturers use the concept of state of the art, but too generally. This requires that you define that you define which parameters of the device you are verifying the state of the art with.

(Please correct me) as per my knowledge, the Clinical Evaluation in MDR is required to explain the alternative therapy or treatment available for the declared intended use of the device under evaluation.

 

[QM_123]

(Please correct me) as per my knowledge, the Clinical Evaluation in MDR is required to explain the alternative therapy or treatment available for the declared intended use of the device under evaluation.

MEDDEV 2.7.1/4 involves the same requirement as well, currently we have to do it. However, I agree with Marcelo, manufacturers (myself included) perform this within a narrow perspective and I think, as things stand with transition to MDR state of the art section of CER will be more important with considering aspects of MDR on this matter.

 

[lisasolo]

Is everyone planning on having a Clinical Evaluation Plan, separate from their clinical evaluation procedure and the Clinical Evaluation Report?

Per the MEDDEV, we include most elements of a clinical evaluation plan within our clinical evaluation report. But the MDR says :
"To plan, continuously conduct and document a clinical evaluation, manufacturers shall: (a) establish and update a clinical evaluation plan, which shall include at least..."

If we include all of the elements required of a clinical evaluation plan within our clinical evaluation report, do you think that this would be sufficient? I don't want to remove the "planning" elements of our clinical evaluation report and separate them into a clinical evaluation plan, because I want our clinical evaluation report to match the MEDDEV. Having a separate plan with a lot of the same elements as in the clinical evaluation report seems redundant.

 

[TycoSQR]

In order to extend the validity of our certificate our notified body asks us among other things a QMS document regarding the update of the clinical evaluation plan in compliance with the MDR.

In this updated procedure regarding the clinical evaluation we decided to separate both plan and report even though a lot of the plan will be found in the report.

 

[Ronen E]

Is everyone planning on having a Clinical Evaluation Plan, separate from their clinical evaluation procedure and the Clinical Evaluation Report?

Per the MEDDEV, we include most elements of a clinical evaluation plan within our clinical evaluation report. But the MDR says :
"To plan, continuously conduct and document a clinical evaluation, manufacturers shall: (a) establish and update a clinical evaluation plan, which shall include at least..."

If we include all of the elements required of a clinical evaluation plan within our clinical evaluation report, do you think that this would be sufficient? I don't want to remove the "planning" elements of our clinical evaluation report and separate them into a clinical evaluation plan, because I want our clinical evaluation report to match the MEDDEV. Having a separate plan with a lot of the same elements as in the clinical evaluation report seems redundant.

In general, it is not a bad practice to include relevant parts of a plan (any plan) in the report summarizing the activity covered in the plan.

Including the planning elements only in a report implies that the planning didn't necessarily take place before commencement of activity.

Regulatory compliance sometimes involves redundancy. That's life