Regulatory Open Forum

Hi Ponzelle,

The requirement for a usability report to be included in your technical documentation for all classes of device under the European Medical Devices Directive (MDD, 93/42/EEC) and Medical Devices Regulation (MDR, 2017/745) is included in the first part of the Essential Requirements (ERs) of the MDD and of the General Safety and Performance Requirements (GSPRs) of the MDR.

Specifically, under the MDD, ER1 requires:

"The devices must be designed and manufactured in such a way that . . . they will not compromise the clinical condition or the safety of patients . . .
This shall include:
- reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
- consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users)."

And under the MDR, GSPR5 requires:

"In eliminating or reducing risks related to use error, the manufacturer shall:
(a) reduce as far as possible the risks related to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
(b) give consideration to the technical knowledge, experience, education, training and use environment, where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or other users)."

Manufacturers often use EN IEC 62366 to generate a 'usability engineering report' that provides a presumption of conformity with these requirements.

Hope this helps.

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Rome, Italy
+39 06 578 2665
rgray@donawa.com
------------------------------

Original Message:
Sent: 24-Jan-2018 18:44
From: Ponzelle Royster
Subject: Usability Studies in Technical File

Is it wise to place a section in the EU Class IIa Technical File for Usability Studies when these studies are only associated with Design Control and sent with submissions for the 510(k)?  I am afraid that we will be setting precedence when we do not have Studies for all product categories. I have researched and cannot find any supporting data that the Studies are required for EU MDD or MDR. 

Original Message------

Hi Ponzelle,

The requirement for a usability report to be included in your technical documentation for all classes of device under the European Medical Devices Directive (MDD, 93/42/EEC) and Medical Devices Regulation (MDR, 2017/745) is included in the first part of the Essential Requirements (ERs) of the MDD and of the General Safety and Performance Requirements (GSPRs) of the MDR.

Specifically, under the MDD, ER1 requires:

"The devices must be designed and manufactured in such a way that . . . they will not compromise the clinical condition or the safety of patients . . .
This shall include:
- reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
- consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users)."

And under the MDR, GSPR5 requires:

"In eliminating or reducing risks related to use error, the manufacturer shall:
(a) reduce as far as possible the risks related to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
(b) give consideration to the technical knowledge, experience, education, training and use environment, where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or other users)."

Manufacturers often use EN IEC 62366 to generate a 'usability engineering report' that provides a presumption of conformity with these requirements.

Hope this helps.

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Rome, Italy
+39 06 578 2665
rgray@donawa.com
------------------------------

I can vouch for Timothy's excellent comment.  For example, over the last 12-18 months on at least 3 or 4 occasions involving at least 3 different Notified Bodies, I've successfully employed the clause 5.10 abbreviated "UOUP" approach.  (UOUP is certainly a strange acronym for User Interface of Unknown Provenance; yet that is indeed the correct acronym defined in EN 62366.)

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com
------------------------------

Original Message:
Sent: 26-Jan-2018 09:41
From: Timothy White
Subject: Usability Studies in Technical File

Our NB has required us to meet EN 62366, as part of our Tech File Assessments for re-certification.  All of our devices are well-established.  Note that EN 62366-1, Section 5.10 allows an abbreviated Usability Engineering process, basically PMS and resulting risk management, for devices with a "User Interface of Unknown Provenance" or established devices.

 

Tim White | Quality Assurance
ASQ - Certified Manager of Quality/Organizational Excellence (CMQOE)

ASQ - Certified Quality Engineer (CQE)

ASQ - Certified Six Sigma Green Belt (CSSGB)

Certified Lead Auditor

Certified Biological Safety Specialist
P:  740-548-4100 x2107  •  www.abrasive-tech.com

twhite@abrasive-tech.com

 

Original Message------

Hi Ponzelle,

The requirement for a usability report to be included in your technical documentation for all classes of device under the European Medical Devices Directive (MDD, 93/42/EEC) and Medical Devices Regulation (MDR, 2017/745) is included in the first part of the Essential Requirements (ERs) of the MDD and of the General Safety and Performance Requirements (GSPRs) of the MDR.

Specifically, under the MDD, ER1 requires:

"The devices must be designed and manufactured in such a way that . . . they will not compromise the clinical condition or the safety of patients . . .
This shall include:
- reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
- consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users)."

And under the MDR, GSPR5 requires:

"In eliminating or reducing risks related to use error, the manufacturer shall:
(a) reduce as far as possible the risks related to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
(b) give consideration to the technical knowledge, experience, education, training and use environment, where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or other users)."

Manufacturers often use EN IEC 62366 to generate a 'usability engineering report' that provides a presumption of conformity with these requirements.

Hope this helps.

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Rome, Italy
+39 06 578 2665
rgray@donawa.com
------------------------------
​

I've always inferred that the authors were jealous of the 62304 use of SOUP for Software of Unknown Provenance

------------------------------
Dan O'Leary
Swanzey NH
United States
------------------------------

Original Message:
Sent: 26-Jan-2018 14:31
From: Kevin Randall
Subject: Usability Studies in Technical File

I can vouch for Timothy's excellent comment.  For example, over the last 12-18 months on at least 3 or 4 occasions involving at least 3 different Notified Bodies, I've successfully employed the clause 5.10 abbreviated "UOUP" approach.  (UOUP is certainly a strange acronym for User Interface of Unknown Provenance; yet that is indeed the correct acronym defined in EN 62366.)

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com

Original Message:
Sent: 26-Jan-2018 09:41
From: Timothy White
Subject: Usability Studies in Technical File

Our NB has required us to meet EN 62366, as part of our Tech File Assessments for re-certification.  All of our devices are well-established.  Note that EN 62366-1, Section 5.10 allows an abbreviated Usability Engineering process, basically PMS and resulting risk management, for devices with a "User Interface of Unknown Provenance" or established devices.

 

Tim White | Quality Assurance
ASQ - Certified Manager of Quality/Organizational Excellence (CMQOE)

ASQ - Certified Quality Engineer (CQE)

ASQ - Certified Six Sigma Green Belt (CSSGB)

Certified Lead Auditor

Certified Biological Safety Specialist
P:  740-548-4100 x2107  •  www.abrasive-tech.com

twhite@abrasive-tech.com

 

Original Message------

Hi Ponzelle,

The requirement for a usability report to be included in your technical documentation for all classes of device under the European Medical Devices Directive (MDD, 93/42/EEC) and Medical Devices Regulation (MDR, 2017/745) is included in the first part of the Essential Requirements (ERs) of the MDD and of the General Safety and Performance Requirements (GSPRs) of the MDR.

Specifically, under the MDD, ER1 requires:

"The devices must be designed and manufactured in such a way that . . . they will not compromise the clinical condition or the safety of patients . . .
This shall include:
- reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
- consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users)."

And under the MDR, GSPR5 requires:

"In eliminating or reducing risks related to use error, the manufacturer shall:
(a) reduce as far as possible the risks related to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
(b) give consideration to the technical knowledge, experience, education, training and use environment, where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or other users)."

Manufacturers often use EN IEC 62366 to generate a 'usability engineering report' that provides a presumption of conformity with these requirements.

Hope this helps.

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Rome, Italy
+39 06 578 2665
rgray@donawa.com
------------------------------
​

​When Dan infers, it always adds a lot of value to our forum discussions. I especially enjoyed that instance.  Thank you Dan!  :)

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com
------------------------------

Original Message:
Sent: 26-Jan-2018 14:46
From: Dan O'Leary
Subject: Usability Studies in Technical File

I've always inferred that the authors were jealous of the 62304 use of SOUP for Software of Unknown Provenance

------------------------------
Dan O'Leary
Swanzey NH
United States

Original Message:
Sent: 26-Jan-2018 14:31
From: Kevin Randall
Subject: Usability Studies in Technical File

I can vouch for Timothy's excellent comment.  For example, over the last 12-18 months on at least 3 or 4 occasions involving at least 3 different Notified Bodies, I've successfully employed the clause 5.10 abbreviated "UOUP" approach.  (UOUP is certainly a strange acronym for User Interface of Unknown Provenance; yet that is indeed the correct acronym defined in EN 62366.)

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com

Original Message:
Sent: 26-Jan-2018 09:41
From: Timothy White
Subject: Usability Studies in Technical File

Our NB has required us to meet EN 62366, as part of our Tech File Assessments for re-certification.  All of our devices are well-established.  Note that EN 62366-1, Section 5.10 allows an abbreviated Usability Engineering process, basically PMS and resulting risk management, for devices with a "User Interface of Unknown Provenance" or established devices.

 

Tim White | Quality Assurance
ASQ - Certified Manager of Quality/Organizational Excellence (CMQOE)

ASQ - Certified Quality Engineer (CQE)

ASQ - Certified Six Sigma Green Belt (CSSGB)

Certified Lead Auditor

Certified Biological Safety Specialist
P:  740-548-4100 x2107  •  www.abrasive-tech.com

twhite@abrasive-tech.com

 

Original Message------

Hi Ponzelle,

The requirement for a usability report to be included in your technical documentation for all classes of device under the European Medical Devices Directive (MDD, 93/42/EEC) and Medical Devices Regulation (MDR, 2017/745) is included in the first part of the Essential Requirements (ERs) of the MDD and of the General Safety and Performance Requirements (GSPRs) of the MDR.

Specifically, under the MDD, ER1 requires:

"The devices must be designed and manufactured in such a way that . . . they will not compromise the clinical condition or the safety of patients . . .
This shall include:
- reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
- consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users)."

And under the MDR, GSPR5 requires:

"In eliminating or reducing risks related to use error, the manufacturer shall:
(a) reduce as far as possible the risks related to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
(b) give consideration to the technical knowledge, experience, education, training and use environment, where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or other users)."

Manufacturers often use EN IEC 62366 to generate a 'usability engineering report' that provides a presumption of conformity with these requirements.

Hope this helps.

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Rome, Italy
+39 06 578 2665
rgray@donawa.com
------------------------------
​

​Roger is spot on.  I would also add that I've had Notified Bodies seek EN 62366 conformity in regards to ER #2.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com
------------------------------

Original Message:
Sent: 24-Jan-2018 18:44
From: Ponzelle Royster
Subject: Usability Studies in Technical File

Is it wise to place a section in the EU Class IIa Technical File for Usability Studies when these studies are only associated with Design Control and sent with submissions for the 510(k)?  I am afraid that we will be setting precedence when we do not have Studies for all product categories. I have researched and cannot find any supporting data that the Studies are required for EU MDD or MDR. 

I agree with both responses. In addition to the report, our NB looked for Usability Engineering process and Usability Engineering file compliance against the standard.

------------------------------
Goldy Singh
VP Regulatory & Clinical Affairs
Mississauga ON
Canada
------------------------------

Original Message:
Sent: 25-Jan-2018 11:08
From: Kevin Randall
Subject: Usability Studies in Technical File

​Roger is spot on.  I would also add that I've had Notified Bodies seek EN 62366 conformity in regards to ER #2.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com

Original Message:
Sent: 24-Jan-2018 18:44
From: Ponzelle Royster
Subject: Usability Studies in Technical File

Is it wise to place a section in the EU Class IIa Technical File for Usability Studies when these studies are only associated with Design Control and sent with submissions for the 510(k)?  I am afraid that we will be setting precedence when we do not have Studies for all product categories. I have researched and cannot find any supporting data that the Studies are required for EU MDD or MDR. 

Dear P:
Usability studies are critical for some devices but not all class IIa devices in EU. It is a key element to meet the essential requirements when needed depending upon a device type. 

Accordingly, it should be included as part of your Technical Documentation (TD) unless you provide reasonably sound justification why it shouldn't be necessary.

------------------------------
Dr. David Lim, Ph.D., RAC, ASQ-CQA
REGULATORY DOCTOR
http://www.RegulatoryDoctor.US
Phone (Toll-Free): 1-(800) 321-8567
E-mail: David@RegulatoryDoctor.US
------------------------------

Original Message:
Sent: 24-Jan-2018 18:44
From: Ponzelle Royster
Subject: Usability Studies in Technical File

Is it wise to place a section in the EU Class IIa Technical File for Usability Studies when these studies are only associated with Design Control and sent with submissions for the 510(k)?  I am afraid that we will be setting precedence when we do not have Studies for all product categories. I have researched and cannot find any supporting data that the Studies are required for EU MDD or MDR. 

Hi All,

Just want to clarify and add some details about the standards to be aware of.  

Note, that you may need to chat with your Notified Body (NB) if you desire to use EN 62366-1:2015 or EN 62366:2008 + A1:2015 both of these are not Harmonized Standards (I double checked as I wrote this post).  So Usability of Unknown Provenance (UOUP) has not been adopted under the Harmonization process yet.  So, the NBs could argue that issue with a manufacturer but you could argue 'state of the art' standard under the MDD and also the MDR.  One caveat about 'State of the Art' doesn't really include UOUP if you think thru the concepts.  UOUP is for older devices and I am still a little perplexed why this concept moved over to 62366-1 as the predecessor standard 62366 had it so manufacturers were supposed to be aware of the requirements in the MDD and design product with Usability in mind for many years now (since at least 2008). 

EN standards are approved and released by CENELEC.  The latest date (Date of Publication or DOP) that EN 62366-1:2015 (not the version including the AC version as missing the superseding note - this version was not ratified) was to be implemented as an EN at a national level by publication of an identical national standard was 2015-12-31 and currently the date of Withdrawal (DOW) by which the national standards conflicting with an EN (and HD for CENELEC) have to withdrawn is 2018-03-31.  The EN 62366-1:2015 supersedes EN 62366:2008 & EN 62366:2008 + A1:2015 per the CENELEC db so that means that in about 2 months EN 62366:08 or EN 62366:08 +A1:15 really should be taken off the Harmonized List of Standards but since this standard is a Joint standard with the IEC TC62/ SC62A (In charge of IEC 60601-1 and Collateral IEC 60601-1-XX + other associated standards like IUEC 62366, 62304, etc.) and ISO/TC 210 (quality management standards such as ISO 13485, ISO 14971, IEC 62366-1, IEC 62304, etc.) committees I know for a fact Harmonization of new standards has slowed to a crawl over the last 5 years or so because the EU Commission has not agreed to the proposed Annex Z's for the IEC 60601 series of standards & related standards that TC62 is in charge of.  COCIR has tried and gotten only maybe a handful or two handfuls of standards Harmonized in that time period which is quite problematic.  As noted above IEC 62366-1 is developed along with the IEC TC62/SC62A committee which is tightly connected to IEC TC62/SC62D (I am one of the 2 US co-chairs for SC62D thru AAMI) where many of the Particular Standards (i.e. IEC 60601-2-XX & IEC/ISO 80601-2-XX) are developed and maintained.

As I mentioned above "...in about 2 months EN 62366:08 or EN 62366:08 +A1:15 really should be taken off the Harmonized List of Standards..." This is not likely to occur as the EU Commission is more focused on high priority standards like EN ISO 13485:2016, which got added to the list in the last round of updates 17.11.2017 (Nov 17, 2017) to the list, and they are getting ready for the Re-harmonization process to move standards to the MDR which will be a slow process as the General Safety & Performance Requirements of Annex I of the MDR are more extensive than the Essential Requirements of the MDD in Annex I.  So, some standards may not make it thru this process.

I could go on more about this topic but got to get onto other things and enjoy my weekend.

You can contact me with questions or join me in Las Vegas for a 1/2 day workshop on IEC 60601-1 Basic March 20, 2018, 1 - 5PM.  More details about the Workshop.

------------------------------
Leonard (Leo) Eisner, P.E.
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 24-Jan-2018 18:44
From: Ponzelle Royster
Subject: Usability Studies in Technical File

Is it wise to place a section in the EU Class IIa Technical File for Usability Studies when these studies are only associated with Design Control and sent with submissions for the 510(k)?  I am afraid that we will be setting precedence when we do not have Studies for all product categories. I have researched and cannot find any supporting data that the Studies are required for EU MDD or MDR. 

I have a concern about the state of affairs when EN 62366-1:2015 becomes a Harmonized Standard. The process, file content, etc. are very different from EN 62366:2008. I worry that NBs will expect the manufacturer to update the usability engineering file to the new standard. This would not result in a change to device, only a change to the supporting documentation. In my opinion, this would be work that doesn't improve the safety or usability of the device.

 

IEC 62366-1:2015 defines User Interface Of Unknown Provenance (UOUP) as a user interface or part of a user interface of a medical device previously developed for which adequate records of the usability engineering process of this standard are not available. Notice that there are two components a) previously developed and b) lacking adequate records to IEC 62366-1:2015.

 

I would like to make the argument that an interface developed under EN 62366:2008 (for an existing device) is UOUP under EN 62366-1:2015 and does not have to be updated when EN 62366-1:2015 is harmonized. If the interface is changed, then the Usability Engineering File is updated using the UOUP methodology.

 

For a new device, follow EN 62366-1:2015.

------------------------------
Dan O'Leary
Swanzey NH
United States
------------------------------

Original Message:
Sent: 27-Jan-2018 14:38
From: Leonard Eisner
Subject: Usability Studies in Technical File

Hi All,

Just want to clarify and add some details about the standards to be aware of.

Note, that you may need to chat with your Notified Body (NB) if you desire to use EN 62366-1:2015 or EN 62366:2008 + A1:2015 both of these are not Harmonized Standards (I double checked as I wrote this post).  So Usability of Unknown Provenance (UOUP) has not been adopted under the Harmonization process yet.  So, the NBs could argue that issue with a manufacturer but you could argue 'state of the art' standard under the MDD and also the MDR.  One caveat about 'State of the Art' doesn't really include UOUP if you think thru the concepts.  UOUP is for older devices and I am still a little perplexed why this concept moved over to 62366-1 as the predecessor standard 62366 had it so manufacturers were supposed to be aware of the requirements in the MDD and design product with Usability in mind for many years now (since at least 2008).

EN standards are approved and released by CENELEC.  The latest date (Date of Publication or DOP) that EN 62366-1:2015 (not the version including the AC version as missing the superseding note - this version was not ratified) was to be implemented as an EN at a national level by publication of an identical national standard was 2015-12-31 and currently the date of Withdrawal (DOW) by which the national standards conflicting with an EN (and HD for CENELEC) have to withdrawn is 2018-03-31.  The EN 62366-1:2015 supersedes EN 62366:2008 & EN 62366:2008 + A1:2015 per the CENELEC db so that means that in about 2 months EN 62366:08 or EN 62366:08 +A1:15 really should be taken off the Harmonized List of Standards but since this standard is a Joint standard with the IEC TC62/ SC62A (In charge of IEC 60601-1 and Collateral IEC 60601-1-XX + other associated standards like IUEC 62366, 62304, etc.) and ISO/TC 210 (quality management standards such as ISO 13485, ISO 14971, IEC 62366-1, IEC 62304, etc.) committees I know for a fact Harmonization of new standards has slowed to a crawl over the last 5 years or so because the EU Commission has not agreed to the proposed Annex Z's for the IEC 60601 series of standards & related standards that TC62 is in charge of.  COCIR has tried and gotten only maybe a handful or two handfuls of standards Harmonized in that time period which is quite problematic.  As noted above IEC 62366-1 is developed along with the IEC TC62/SC62A committee which is tightly connected to IEC TC62/SC62D (I am one of the 2 US co-chairs for SC62D thru AAMI) where many of the Particular Standards (i.e. IEC 60601-2-XX & IEC/ISO 80601-2-XX) are developed and maintained.

As I mentioned above "...in about 2 months EN 62366:08 or EN 62366:08 +A1:15 really should be taken off the Harmonized List of Standards..." This is not likely to occur as the EU Commission is more focused on high priority standards like EN ISO 13485:2016, which got added to the list in the last round of updates 17.11.2017 (Nov 17, 2017) to the list, and they are getting ready for the Re-harmonization process to move standards to the MDR which will be a slow process as the General Safety & Performance Requirements of Annex I of the MDR are more extensive than the Essential Requirements of the MDD in Annex I.  So, some standards may not make it thru this process.

I could go on more about this topic but got to get onto other things and enjoy my weekend.

You can contact me with questions or join me in Las Vegas for a 1/2 day workshop on IEC 60601-1 Basic March 20, 2018, 1 - 5PM.  More details about the Workshop.

------------------------------
Leonard (Leo) Eisner, P.E.
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com

Original Message:
Sent: 24-Jan-2018 18:44
From: Ponzelle Royster
Subject: Usability Studies in Technical File

Is it wise to place a section in the EU Class IIa Technical File for Usability Studies when these studies are only associated with Design Control and sent with submissions for the 510(k)?  I am afraid that we will be setting precedence when we do not have Studies for all product categories. I have researched and cannot find any supporting data that the Studies are required for EU MDD or MDR. 

​As Leo suggested, I ran the use of EN 62366:2015 by our NB.  We are going through the re-certification Technical Information File assessments.  The NB replied that:
My view is that a report reflecting the 2015 version may well be submitted, but to ensure its acceptance I would also have submitted a "gap" analysis in regard to possible differences between the harmonized (2008) version and the 2015 version. The existence of a 2015 version still not harmonized may indicate that there may be requirements in the 2008 version that may be changed or omitted in the 2015 version, and that should be clarified in the gap analysis.

If anyone has completed such a gap analysis, would you mind sharing it?

------------------------------
Tim White
Leadership, QA
Lewis Center OH
United States
------------------------------

Original Message:
Sent: 29-Jan-2018 06:55
From: Dan O'Leary
Subject: Usability Studies in Technical File

I have a concern about the state of affairs when EN 62366-1:2015 becomes a Harmonized Standard. The process, file content, etc. are very different from EN 62366:2008. I worry that NBs will expect the manufacturer to update the usability engineering file to the new standard. This would not result in a change to device, only a change to the supporting documentation. In my opinion, this would be work that doesn't improve the safety or usability of the device.

 

IEC 62366-1:2015 defines User Interface Of Unknown Provenance (UOUP) as a user interface or part of a user interface of a medical device previously developed for which adequate records of the usability engineering process of this standard are not available. Notice that there are two components a) previously developed and b) lacking adequate records to IEC 62366-1:2015.

 

I would like to make the argument that an interface developed under EN 62366:2008 (for an existing device) is UOUP under EN 62366-1:2015 and does not have to be updated when EN 62366-1:2015 is harmonized. If the interface is changed, then the Usability Engineering File is updated using the UOUP methodology.

 

For a new device, follow EN 62366-1:2015.

------------------------------
Dan O'Leary
Swanzey NH
United States

Original Message:
Sent: 27-Jan-2018 14:38
From: Leonard Eisner
Subject: Usability Studies in Technical File

Hi All,

Just want to clarify and add some details about the standards to be aware of.

Note, that you may need to chat with your Notified Body (NB) if you desire to use EN 62366-1:2015 or EN 62366:2008 + A1:2015 both of these are not Harmonized Standards (I double checked as I wrote this post).  So Usability of Unknown Provenance (UOUP) has not been adopted under the Harmonization process yet.  So, the NBs could argue that issue with a manufacturer but you could argue 'state of the art' standard under the MDD and also the MDR.  One caveat about 'State of the Art' doesn't really include UOUP if you think thru the concepts.  UOUP is for older devices and I am still a little perplexed why this concept moved over to 62366-1 as the predecessor standard 62366 had it so manufacturers were supposed to be aware of the requirements in the MDD and design product with Usability in mind for many years now (since at least 2008).

EN standards are approved and released by CENELEC.  The latest date (Date of Publication or DOP) that EN 62366-1:2015 (not the version including the AC version as missing the superseding note - this version was not ratified) was to be implemented as an EN at a national level by publication of an identical national standard was 2015-12-31 and currently the date of Withdrawal (DOW) by which the national standards conflicting with an EN (and HD for CENELEC) have to withdrawn is 2018-03-31.  The EN 62366-1:2015 supersedes EN 62366:2008 & EN 62366:2008 + A1:2015 per the CENELEC db so that means that in about 2 months EN 62366:08 or EN 62366:08 +A1:15 really should be taken off the Harmonized List of Standards but since this standard is a Joint standard with the IEC TC62/ SC62A (In charge of IEC 60601-1 and Collateral IEC 60601-1-XX + other associated standards like IUEC 62366, 62304, etc.) and ISO/TC 210 (quality management standards such as ISO 13485, ISO 14971, IEC 62366-1, IEC 62304, etc.) committees I know for a fact Harmonization of new standards has slowed to a crawl over the last 5 years or so because the EU Commission has not agreed to the proposed Annex Z's for the IEC 60601 series of standards & related standards that TC62 is in charge of.  COCIR has tried and gotten only maybe a handful or two handfuls of standards Harmonized in that time period which is quite problematic.  As noted above IEC 62366-1 is developed along with the IEC TC62/SC62A committee which is tightly connected to IEC TC62/SC62D (I am one of the 2 US co-chairs for SC62D thru AAMI) where many of the Particular Standards (i.e. IEC 60601-2-XX & IEC/ISO 80601-2-XX) are developed and maintained.

As I mentioned above "...in about 2 months EN 62366:08 or EN 62366:08 +A1:15 really should be taken off the Harmonized List of Standards..." This is not likely to occur as the EU Commission is more focused on high priority standards like EN ISO 13485:2016, which got added to the list in the last round of updates 17.11.2017 (Nov 17, 2017) to the list, and they are getting ready for the Re-harmonization process to move standards to the MDR which will be a slow process as the General Safety & Performance Requirements of Annex I of the MDR are more extensive than the Essential Requirements of the MDD in Annex I.  So, some standards may not make it thru this process.

I could go on more about this topic but got to get onto other things and enjoy my weekend.

You can contact me with questions or join me in Las Vegas for a 1/2 day workshop on IEC 60601-1 Basic March 20, 2018, 1 - 5PM.  More details about the Workshop.

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Leonard (Leo) Eisner, P.E.
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com

Original Message:
Sent: 24-Jan-2018 18:44
From: Ponzelle Royster
Subject: Usability Studies in Technical File

Is it wise to place a section in the EU Class IIa Technical File for Usability Studies when these studies are only associated with Design Control and sent with submissions for the 510(k)?  I am afraid that we will be setting precedence when we do not have Studies for all product categories. I have researched and cannot find any supporting data that the Studies are required for EU MDD or MDR.