Regulatory Open Forum

My question is focused on who should be conducted all of the necessary planning, research, review, and authoring activities for a CER.

The way I interpret MEDDEV 2.7/1 revision 4 is that the person qualified as the "evaluator" for a CER has responsibility for carrying out ALL of the activities required for a CER, including defining the evaluation plan, reviewing the literature/data, and authoring the final CER report.  Is this the intent of the MEDDEV, or is it appropriate to have a person who is NOT qualified as an "evaluator" in their own right to do all of the work then pass it on for review and approval by a qualified "evaluator"?  If there is flexibility, what tasks would be appropriate for a non-qualified person to do on behalf of the evaluator?

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Aroa Biosurgery
Auckland
New Zealand
------------------------------

So, my first reaction is "I don't care what the MEDDEV says, that ain't never going to happen."

Then I searched for "evaluator" in the MEDDEV.  Based on how I work with evaluators, I don't see anything in it that says they really have to do anything but evaluate. 

But that's based on how I work with the evaluators, which is, for starters, that I work with them.  I know that some big companies have been farming out CERs en masse the last few years, apparently to organizations that are essentially staffing agencies.  I don't know if the people who end up writing CERs under these circumstances work with the evaluators, or even ever know who they are.

But the key thing that leaps out at me is that there is no way for anyone to ever know who did the work, another reason that it ain't never going to happen.

What do you read in the MEDDEV that makes you think differently?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 31-May-2017 17:31
From: Tina O'Brien
Subject: CER Preparation Responsibility

My question is focused on who should be conducted all of the necessary planning, research, review, and authoring activities for a CER.

The way I interpret MEDDEV 2.7/1 revision 4 is that the person qualified as the "evaluator" for a CER has responsibility for carrying out ALL of the activities required for a CER, including defining the evaluation plan, reviewing the literature/data, and authoring the final CER report.  Is this the intent of the MEDDEV, or is it appropriate to have a person who is NOT qualified as an "evaluator" in their own right to do all of the work then pass it on for review and approval by a qualified "evaluator"?  If there is flexibility, what tasks would be appropriate for a non-qualified person to do on behalf of the evaluator?

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Aroa Biosurgery
Auckland
New Zealand
------------------------------

Original Message------

So, my first reaction is "I don't care what the MEDDEV says, that ain't never going to happen."

Then I searched for "evaluator" in the MEDDEV.  Based on how I work with evaluators, I don't see anything in it that says they really have to do anything but evaluate. 

But that's based on how I work with the evaluators, which is, for starters, that I work with them.  I know that some big companies have been farming out CERs en masse the last few years, apparently to organizations that are essentially staffing agencies.  I don't know if the people who end up writing CERs under these circumstances work with the evaluators, or even ever know who they are.

But the key thing that leaps out at me is that there is no way for anyone to ever know who did the work, another reason that it ain't never going to happen.

What do you read in the MEDDEV that makes you think differently?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Hi Tina-

I've written many CERs for a variety of devices. The final "approval" or signature on each CER is that of a clinician who has experience in the clinical use of these devices for their approve intended and indicated uses. As a biomedical engineer, I am often more familiar with the technology and the pre-clinical tests that were applied to demonstrate acceptable performance/ conformance with standards to allow the devices to be used clinically. That is, I know how the devices are designed to function, but I am not familiar with the nuances of their clinical application.

I typically take responsibility for the entire preparation of the CER, using information on complaints provided by the device manufacturer, and sometimes the results of their literature search. I evaluate the literature and the acceptability of the clinical data, and then this evaluation is passed on to a clinician for final approval.

I am not sure if this answers your question, but this is the process I've followed and it has been successful in that NBs have accepted the CERs that have been prepared and approved in this fashion.

Best,
Phil

------------------------------
Phill Triolo PhD RAC
President
Phil Triolo & Associates LC
Salt Lake City UT
United StatesPhilip
------------------------------

Original Message:
Sent: 31-May-2017 17:31
From: Tina O'Brien
Subject: CER Preparation Responsibility

My question is focused on who should be conducted all of the necessary planning, research, review, and authoring activities for a CER.

The way I interpret MEDDEV 2.7/1 revision 4 is that the person qualified as the "evaluator" for a CER has responsibility for carrying out ALL of the activities required for a CER, including defining the evaluation plan, reviewing the literature/data, and authoring the final CER report.  Is this the intent of the MEDDEV, or is it appropriate to have a person who is NOT qualified as an "evaluator" in their own right to do all of the work then pass it on for review and approval by a qualified "evaluator"?  If there is flexibility, what tasks would be appropriate for a non-qualified person to do on behalf of the evaluator?

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Aroa Biosurgery
Auckland
New Zealand
------------------------------

This is done through qualified (trained) individuals in the Regulatory department, working with Design Assurance, a clinician familiar with the product, and QA folks who assist with post-market information. Both the RA person and the clinician sign the document, and DA folks sign for risk/usability information.

------------------------------
Corey Jaseph RAC
Regulatory Affairs Manager
Ultradent Products, Inc.
South Jordan UT
United States
------------------------------

Original Message:
Sent: 31-May-2017 17:31
From: Tina O'Brien
Subject: CER Preparation Responsibility

My question is focused on who should be conducted all of the necessary planning, research, review, and authoring activities for a CER.

The way I interpret MEDDEV 2.7/1 revision 4 is that the person qualified as the "evaluator" for a CER has responsibility for carrying out ALL of the activities required for a CER, including defining the evaluation plan, reviewing the literature/data, and authoring the final CER report.  Is this the intent of the MEDDEV, or is it appropriate to have a person who is NOT qualified as an "evaluator" in their own right to do all of the work then pass it on for review and approval by a qualified "evaluator"?  If there is flexibility, what tasks would be appropriate for a non-qualified person to do on behalf of the evaluator?

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Aroa Biosurgery
Auckland
New Zealand
------------------------------

Hi Tina,

I agree with the comments expressed by others who replied to your message; completing the clinical evaluation requires a team of qualified evaluators.  The process begins with a Clinical Evaluation Plan, where sources of data are defined and roles established within the team.  When we help clients with CERs, we have a librarian who performs the clinical literature searches (working closely with the manufacturer for appropriate search terms).  Regulatory professionals with CER experiece ensure that there is sufficient clinical data to support conformity with the ERs.  Along the way, we must get input from those who know the product best, engineers and clinicians.  In the end, the manufacturer is ultimately responsible for the CER with support from the number of evaluators that are deemed appropriate.  We find that a team approach works best.

------------------------------
Carol Vierling, RAC
Senior Principal Advisor
Regulatory and Quality Solutions

------------------------------

Original Message:
Sent: 31-May-2017 17:31
From: Tina O'Brien
Subject: CER Preparation Responsibility

My question is focused on who should be conducted all of the necessary planning, research, review, and authoring activities for a CER.

The way I interpret MEDDEV 2.7/1 revision 4 is that the person qualified as the "evaluator" for a CER has responsibility for carrying out ALL of the activities required for a CER, including defining the evaluation plan, reviewing the literature/data, and authoring the final CER report.  Is this the intent of the MEDDEV, or is it appropriate to have a person who is NOT qualified as an "evaluator" in their own right to do all of the work then pass it on for review and approval by a qualified "evaluator"?  If there is flexibility, what tasks would be appropriate for a non-qualified person to do on behalf of the evaluator?

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Aroa Biosurgery
Auckland
New Zealand
------------------------------

Thanks for the feedback!  Definitely some good info as we refine our process.  As we are in the early stages of pursuing EC Certification for our Class III devices, I want to make sure we have the right people doing the right things to avoid any issues. 

I wouldn't be so concerned if we had lower class devices - any CER issues would likely be identified during an audit, thus allowing ample time to resolve them - likely without interruption to sales.   With a Class III design dossier review, significant issues could stop us in our tracks. 

Given the revision to the MEDDEV and the approval of MDR, do you think that the level of CER scrutiny by NBs will increase?

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Aroa Biosurgery
Auckland
New Zealand
------------------------------

Original Message:
Sent: 31-May-2017 17:31
From: Tina O'Brien
Subject: CER Preparation Responsibility

My question is focused on who should be conducted all of the necessary planning, research, review, and authoring activities for a CER.

The way I interpret MEDDEV 2.7/1 revision 4 is that the person qualified as the "evaluator" for a CER has responsibility for carrying out ALL of the activities required for a CER, including defining the evaluation plan, reviewing the literature/data, and authoring the final CER report.  Is this the intent of the MEDDEV, or is it appropriate to have a person who is NOT qualified as an "evaluator" in their own right to do all of the work then pass it on for review and approval by a qualified "evaluator"?  If there is flexibility, what tasks would be appropriate for a non-qualified person to do on behalf of the evaluator?

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Aroa Biosurgery
Auckland
New Zealand
------------------------------

Hi Tina,

My company has EU Class III devices and every interaction with our NB in the last year has involved at minimum a discussion of the MEDDEV enhancements of CERs, so the answer to your question for us is YES!

Ian

------------------------------
Ian Christianson
Marlborough MA
United States
------------------------------

Original Message:
Sent: 02-Jun-2017 20:52
From: Tina O'Brien
Subject: CER Preparation Responsibility

Thanks for the feedback!  Definitely some good info as we refine our process.  As we are in the early stages of pursuing EC Certification for our Class III devices, I want to make sure we have the right people doing the right things to avoid any issues. 

I wouldn't be so concerned if we had lower class devices - any CER issues would likely be identified during an audit, thus allowing ample time to resolve them - likely without interruption to sales.   With a Class III design dossier review, significant issues could stop us in our tracks. 

Given the revision to the MEDDEV and the approval of MDR, do you think that the level of CER scrutiny by NBs will increase?

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Aroa Biosurgery
Auckland
New Zealand
------------------------------

Original Message:
Sent: 31-May-2017 17:31
From: Tina O'Brien
Subject: CER Preparation Responsibility

My question is focused on who should be conducted all of the necessary planning, research, review, and authoring activities for a CER.

The way I interpret MEDDEV 2.7/1 revision 4 is that the person qualified as the "evaluator" for a CER has responsibility for carrying out ALL of the activities required for a CER, including defining the evaluation plan, reviewing the literature/data, and authoring the final CER report.  Is this the intent of the MEDDEV, or is it appropriate to have a person who is NOT qualified as an "evaluator" in their own right to do all of the work then pass it on for review and approval by a qualified "evaluator"?  If there is flexibility, what tasks would be appropriate for a non-qualified person to do on behalf of the evaluator?

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Aroa Biosurgery
Auckland
New Zealand
------------------------------

Original Message------

Given the revision to the MEDDEV and the approval of MDR, do you think that the level of CER scrutiny by NBs will increase?

Tina O'Brien,  02-Jun-2017 20:52

Hi Tina,

My company has EU Class III devices and every interaction with our NB in the last year has involved at minimum a discussion of the MEDDEV enhancements of CERs, so the answer to your question for us is YES!

Ian

------------------------------
Ian Christianson
Marlborough MA
United States
------------------------------

​I guess it depends on what you mean by scrutiny.  If you mean will they look at them now, where they did not in the past, I think the answer is probably yes.  If you mean they will "look at" them to see if they appear to have been updated to Rev 4, I think the answer is probably yes.

Anything more substantive than that, my question is not will they, but can they.  Has anyone had an NB auditor find anything in the content of a CER lacking?


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 21-Jun-2017 06:39
From: James Bonds
Subject: CER Preparation Responsibility

In a word, yes, the NBs will scrutinize the CERs.  A recent NB inspection resulted in a Major NC because our CERs had not been updated since the new revision of the MEDDEV was issued.  We manufacture Class IIA devices, and the NB didn't find our CERs lacking in content, only that they didn't address the specifics of the MEDDEV with respect to justification of search terms.  The NC was because we did not have a procedure that mirrored the MEDDEV.  Our response during the audit was that the CER referenced the MEDDEV and the auditor replied that although that was adequate before, it is no longer adequate.  You need to have an internal procedure for CER preparation.

If the CER is part of the original review of a Class III design dossier, that is indeed a unique situation.  I still don't think the evaluators need to do anything more than evaluate, but I think the CER itself will get much closer scrutiny than other CERs under other circumstances.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 02-Jun-2017 20:52
From: Tina O'Brien
Subject: CER Preparation Responsibility

Thanks for the feedback!  Definitely some good info as we refine our process.  As we are in the early stages of pursuing EC Certification for our Class III devices, I want to make sure we have the right people doing the right things to avoid any issues. 

I wouldn't be so concerned if we had lower class devices - any CER issues would likely be identified during an audit, thus allowing ample time to resolve them - likely without interruption to sales.   With a Class III design dossier review, significant issues could stop us in our tracks. 

Given the revision to the MEDDEV and the approval of MDR, do you think that the level of CER scrutiny by NBs will increase?

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Aroa Biosurgery
Auckland
New Zealand
------------------------------

Original Message:
Sent: 31-May-2017 17:31
From: Tina O'Brien
Subject: CER Preparation Responsibility

My question is focused on who should be conducted all of the necessary planning, research, review, and authoring activities for a CER.

The way I interpret MEDDEV 2.7/1 revision 4 is that the person qualified as the "evaluator" for a CER has responsibility for carrying out ALL of the activities required for a CER, including defining the evaluation plan, reviewing the literature/data, and authoring the final CER report.  Is this the intent of the MEDDEV, or is it appropriate to have a person who is NOT qualified as an "evaluator" in their own right to do all of the work then pass it on for review and approval by a qualified "evaluator"?  If there is flexibility, what tasks would be appropriate for a non-qualified person to do on behalf of the evaluator?

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Aroa Biosurgery
Auckland
New Zealand
------------------------------

​A separate question is who signs it.

A CER is a report, not a regulatory submission, that, like many other kinds of reports, is available to be included in a submission if needed.  

I think a report is signed by its "author(s)," who didn't necessarily "write" the report, but are in a position to take responsibility for its contents, while approval signatures indicate acceptance of the report by the company. I'm used to seeing those signatures captured on a separate approval document, which is not part of the report itself, so as not to confuse approval with authorship.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 31-May-2017 17:31
From: Tina O'Brien
Subject: CER Preparation Responsibility

My question is focused on who should be conducted all of the necessary planning, research, review, and authoring activities for a CER.

The way I interpret MEDDEV 2.7/1 revision 4 is that the person qualified as the "evaluator" for a CER has responsibility for carrying out ALL of the activities required for a CER, including defining the evaluation plan, reviewing the literature/data, and authoring the final CER report.  Is this the intent of the MEDDEV, or is it appropriate to have a person who is NOT qualified as an "evaluator" in their own right to do all of the work then pass it on for review and approval by a qualified "evaluator"?  If there is flexibility, what tasks would be appropriate for a non-qualified person to do on behalf of the evaluator?

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Aroa Biosurgery
Auckland
New Zealand
------------------------------