Regulatory Open Forum

Hello Colleagues,

When completing the ER Checklist to demonstrate compliance with the EU MDD Essential Requirements, do you include reference to all the standards and supporting documentation in the "General Requirements, #1" section?  Also, do you include reference to 14971 and 13485 in all the sections applicable to your device? I have seen ERCs that reference only 14971 and 13485 in Section 1 and others where every standard and document referenced throughout the ERC is included in #1.

I have seen so many variations for which standards are included in various sections of the ERC and wonder which is the most standard practice or is one way more correct than the other.  It seems to me, that all documentation generated to support compliance with the ERs would all be developed under the quality and risks standards.

Thanks so much.  I look forward to your feedback.

Sharon,

Here is how I do.

First, I do try to use all standards, if used, by a firm(s).

First Column: List of ERs
Second Column:   Standards applied by the firm(s)
Third Column:   Other standards or procedures applied by the firm(s) 
Fourth Column:   Evidence of compliance or reason for non-compliance

I try to make it look good and highly organized!

Vision trumps all senses!

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Regulatory Doctor, Coach, Mentor, and Consultant
www.GlobalComplianceSeminar.Com
Riner VA
United States
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Original Message:
Sent: 01-04-2013 12:54
From: Sharon McDermott
Subject: Referencing Standards in EU MDD ER Checklist

Hello Colleagues,

When completing the ER Checklist to demonstrate compliance with the EU MDD Essential Requirements, do you include reference to all the standards and supporting documentation in the "General Requirements, #1" section?  Also, do you include reference to 14971 and 13485 in all the sections applicable to your device? I have seen ERCs that reference only 14971 and 13485 in Section 1 and others where every standard and document referenced throughout the ERC is included in #1.

I have seen so many variations for which standards are included in various sections of the ERC and wonder which is the most standard practice or is one way more correct than the other.  It seems to me, that all documentation generated to support compliance with the ERs would all be developed under the quality and risks standards.

Thanks so much.  I look forward to your feedback.

I agree, the list should be organized well and according to your needs and devices. There is no special requirement on how to reference, so from my point of view, the most important thing is, that it suits your needs.
This is the way the ER are supposed to work anyways. A "better than" does not really exist, however, it should be noted that some notified bodies provide sample lists and talking to them - telling them how you use your list makes it easier for them to understand.
You can also include a short statement on how to read your list, this also makes it easier to read.

I currently use a list where I reference the standards that apply to each requirement - in other words, I mention standards many times if they apply to various requiremets. This way, it is easy to filter for a standard and see all requirements, that are connected to it.

In the past I have also created a checklist that included the ER but was way more complete in order to fulfill the requirements for joint implants. So in the end, we had a checklist for joint implant requirements - incl. all ER. The notified body was very happy with that because they checked for all requirements as well and this way had an easy overview on everything within one list.

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Florian Tolkmitt
sfm medical devices GmbH
Waechtersbach
Germany
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Original Message:
Sent: 01-04-2013 12:54
From: Sharon McDermott
Subject: Referencing Standards in EU MDD ER Checklist

Hello Colleagues,

When completing the ER Checklist to demonstrate compliance with the EU MDD Essential Requirements, do you include reference to all the standards and supporting documentation in the "General Requirements, #1" section?  Also, do you include reference to 14971 and 13485 in all the sections applicable to your device? I have seen ERCs that reference only 14971 and 13485 in Section 1 and others where every standard and document referenced throughout the ERC is included in #1.

I have seen so many variations for which standards are included in various sections of the ERC and wonder which is the most standard practice or is one way more correct than the other.  It seems to me, that all documentation generated to support compliance with the ERs would all be developed under the quality and risks standards.

Thanks so much.  I look forward to your feedback.

Refer to Annex Z of the standards. This section provides the correspondence between the clause/subcaluse of the std. and the Essential Requirements of the Directive. It also provides qualifying remarks to better understand how stds can be applied.

Hope this helps.

Regards,
-------------------------------------------
Mary Gray RAC
Regulatory Affairs Manager
Marstons Mills MA
United States
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Original Message:
Sent: 01-04-2013 12:54
From: Sharon McDermott
Subject: Referencing Standards in EU MDD ER Checklist

Hello Colleagues,

When completing the ER Checklist to demonstrate compliance with the EU MDD Essential Requirements, do you include reference to all the standards and supporting documentation in the "General Requirements, #1" section?  Also, do you include reference to 14971 and 13485 in all the sections applicable to your device? I have seen ERCs that reference only 14971 and 13485 in Section 1 and others where every standard and document referenced throughout the ERC is included in #1.

I have seen so many variations for which standards are included in various sections of the ERC and wonder which is the most standard practice or is one way more correct than the other.  It seems to me, that all documentation generated to support compliance with the ERs would all be developed under the quality and risks standards.

Thanks so much.  I look forward to your feedback.

NB-MED/2.5.1 is a good guidance on how to prepare technical files and Essential Reqs. checklists.

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Timothy White
Lewis Center OH
United States
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Original Message:
Sent: 01-07-2013 07:24
From: Mary Gray
Subject: Referencing Standards in EU MDD ER Checklist

Refer to Annex Z of the standards. This section provides the correspondence between the clause/subcaluse of the std. and the Essential Requirements of the Directive. It also provides qualifying remarks to better understand how stds can be applied.

Hope this helps.

Regards,
-------------------------------------------
Mary Gray RAC
Regulatory Affairs Manager
Marstons Mills MA
United States
-------------------------------------------






Original Message:
Sent: 01-04-2013 12:54
From: Sharon McDermott
Subject: Referencing Standards in EU MDD ER Checklist

Hello Colleagues,

When completing the ER Checklist to demonstrate compliance with the EU MDD Essential Requirements, do you include reference to all the standards and supporting documentation in the "General Requirements, #1" section?  Also, do you include reference to 14971 and 13485 in all the sections applicable to your device? I have seen ERCs that reference only 14971 and 13485 in Section 1 and others where every standard and document referenced throughout the ERC is included in #1.

I have seen so many variations for which standards are included in various sections of the ERC and wonder which is the most standard practice or is one way more correct than the other.  It seems to me, that all documentation generated to support compliance with the ERs would all be developed under the quality and risks standards.

Thanks so much.  I look forward to your feedback.