Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi Everyone,

I am hoping that someone in the community might be able to help me out. 

I understand that the deadline for 60601-1-2 4th edition for Europe, USA, and Canada is December 31, 2018.  Any new devices manufactured and sold to Europe, USA, and Canada must be compliant with the 4th edition after the deadline.

What is unclear to me is the following:  We have already sold some of our 3rd edition tested devices to distributors in the three countries listed above but they still have inventory on their shelves that they have not sold to customers in their respective countries.  Are the distributors allowed to sell those 3rd edition devices in their own country after the deadline or do we need to replace all of their inventory with 4th edition devices so that they can continue to sell after the deadline?

Thank you for your help!!

DS

Hello,

I can give my interpretation, but others may have differing opinions and the individual country laws and regulations may have specific import or export requirements.  When the device(s) have left your facility, your possession, these are considered to be "placed on the market" because a distributor is a separate entity.  A material and financial transaction has occurred, so those devices that are compliant to 3rd Edition on a distributor's inventory location/shelf after 31 Dec 2018 would still be legally valid.  Meaning they would not need to be retrieved, reworked, or retested depending on any changes you had to make to the device from 3rd Edition to 4th Edition compliance (hopefully not much).  Now if this distributor is your own company, the warehouse or inventory an "extension" of manufacturing activities and storage, then they are still under your control and should be updated/revised for 4th Edition compliance.  There are some definitions contained in the Medical Device Regulation such as 'making available on the market' or 'placing on the market' so while I do not think those definitions make it clear, there is a presumption the product is sold.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 09-Oct-2018 16:24
From: Anonymous Member
Subject: 60601-1-2 4th edition European Compliance

This message was posted by a user wishing to remain anonymous

Hi Everyone,

I am hoping that someone in the community might be able to help me out.

I understand that the deadline for 60601-1-2 4th edition for Europe, USA, and Canada is December 31, 2018.  Any new devices manufactured and sold to Europe, USA, and Canada must be compliant with the 4th edition after the deadline.

What is unclear to me is the following:  We have already sold some of our 3rd edition tested devices to distributors in the three countries listed above but they still have inventory on their shelves that they have not sold to customers in their respective countries.  Are the distributors allowed to sell those 3rd edition devices in their own country after the deadline or do we need to replace all of their inventory with 4th edition devices so that they can continue to sell after the deadline?

Thank you for your help!!

DS

I completely agree that once product has been sold and out of the legal manufacturer's possession, that it is "in the field" and can be sold by the distributor without concern for the new regulation to be implemented in 2019.

------------------------------
Lauren Ziegler RAC
Global Program, Regulatory Director
Montville NJ
United States
------------------------------

Original Message:
Sent: 10-Oct-2018 06:31
From: Richard Vincins
Subject: 60601-1-2 4th edition European Compliance

Hello,

I can give my interpretation, but others may have differing opinions and the individual country laws and regulations may have specific import or export requirements.  When the device(s) have left your facility, your possession, these are considered to be "placed on the market" because a distributor is a separate entity.  A material and financial transaction has occurred, so those devices that are compliant to 3rd Edition on a distributor's inventory location/shelf after 31 Dec 2018 would still be legally valid.  Meaning they would not need to be retrieved, reworked, or retested depending on any changes you had to make to the device from 3rd Edition to 4th Edition compliance (hopefully not much).  Now if this distributor is your own company, the warehouse or inventory an "extension" of manufacturing activities and storage, then they are still under your control and should be updated/revised for 4th Edition compliance.  There are some definitions contained in the Medical Device Regulation such as 'making available on the market' or 'placing on the market' so while I do not think those definitions make it clear, there is a presumption the product is sold.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 09-Oct-2018 16:24
From: Anonymous Member
Subject: 60601-1-2 4th edition European Compliance

This message was posted by a user wishing to remain anonymous

Hi Everyone,

I am hoping that someone in the community might be able to help me out.

I understand that the deadline for 60601-1-2 4th edition for Europe, USA, and Canada is December 31, 2018.  Any new devices manufactured and sold to Europe, USA, and Canada must be compliant with the 4th edition after the deadline.

What is unclear to me is the following:  We have already sold some of our 3rd edition tested devices to distributors in the three countries listed above but they still have inventory on their shelves that they have not sold to customers in their respective countries.  Are the distributors allowed to sell those 3rd edition devices in their own country after the deadline or do we need to replace all of their inventory with 4th edition devices so that they can continue to sell after the deadline?

Thank you for your help!!

DS

This message was posted by a user wishing to remain anonymous

Thank you very much Richard and Lauren.  I greatly appreciate your input!
Original Message:
Sent: 10-Oct-2018 07:39
From: Lauren Ziegler
Subject: 60601-1-2 4th edition European Compliance

I completely agree that once product has been sold and out of the legal manufacturer's possession, that it is "in the field" and can be sold by the distributor without concern for the new regulation to be implemented in 2019.

------------------------------
Lauren Ziegler RAC
Global Program, Regulatory Director
Montville NJ
United States

Original Message:
Sent: 10-Oct-2018 06:31
From: Richard Vincins
Subject: 60601-1-2 4th edition European Compliance

Hello,

I can give my interpretation, but others may have differing opinions and the individual country laws and regulations may have specific import or export requirements.  When the device(s) have left your facility, your possession, these are considered to be "placed on the market" because a distributor is a separate entity.  A material and financial transaction has occurred, so those devices that are compliant to 3rd Edition on a distributor's inventory location/shelf after 31 Dec 2018 would still be legally valid.  Meaning they would not need to be retrieved, reworked, or retested depending on any changes you had to make to the device from 3rd Edition to 4th Edition compliance (hopefully not much).  Now if this distributor is your own company, the warehouse or inventory an "extension" of manufacturing activities and storage, then they are still under your control and should be updated/revised for 4th Edition compliance.  There are some definitions contained in the Medical Device Regulation such as 'making available on the market' or 'placing on the market' so while I do not think those definitions make it clear, there is a presumption the product is sold.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 09-Oct-2018 16:24
From: Anonymous Member
Subject: 60601-1-2 4th edition European Compliance

This message was posted by a user wishing to remain anonymous

Hi Everyone,

I am hoping that someone in the community might be able to help me out.

I understand that the deadline for 60601-1-2 4th edition for Europe, USA, and Canada is December 31, 2018.  Any new devices manufactured and sold to Europe, USA, and Canada must be compliant with the 4th edition after the deadline.

What is unclear to me is the following:  We have already sold some of our 3rd edition tested devices to distributors in the three countries listed above but they still have inventory on their shelves that they have not sold to customers in their respective countries.  Are the distributors allowed to sell those 3rd edition devices in their own country after the deadline or do we need to replace all of their inventory with 4th edition devices so that they can continue to sell after the deadline?

Thank you for your help!!

DS

I agree with Richard for the most part other than one issue for the EU which is the transfer of ownership does not need to end up in financial transfer as there are times when devices (capital equipment) are loaned to the end user and then the disposables are sold to the end user.

I had a question on IEC 60601-1-2, 4th ed last week focused on the EU so I am repeating below. 

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 10-Oct-2018 15:23
From: Anonymous Member
Subject: 60601-1-2 4th edition European Compliance

This message was posted by a user wishing to remain anonymous

Thank you very much Richard and Lauren.  I greatly appreciate your input!
Original Message:
Sent: 10-Oct-2018 07:39
From: Lauren Ziegler
Subject: 60601-1-2 4th edition European Compliance

I completely agree that once product has been sold and out of the legal manufacturer's possession, that it is "in the field" and can be sold by the distributor without concern for the new regulation to be implemented in 2019.

------------------------------
Lauren Ziegler RAC
Global Program, Regulatory Director
Montville NJ
United States

Original Message:
Sent: 10-Oct-2018 06:31
From: Richard Vincins
Subject: 60601-1-2 4th edition European Compliance

Hello,

I can give my interpretation, but others may have differing opinions and the individual country laws and regulations may have specific import or export requirements.  When the device(s) have left your facility, your possession, these are considered to be "placed on the market" because a distributor is a separate entity.  A material and financial transaction has occurred, so those devices that are compliant to 3rd Edition on a distributor's inventory location/shelf after 31 Dec 2018 would still be legally valid.  Meaning they would not need to be retrieved, reworked, or retested depending on any changes you had to make to the device from 3rd Edition to 4th Edition compliance (hopefully not much).  Now if this distributor is your own company, the warehouse or inventory an "extension" of manufacturing activities and storage, then they are still under your control and should be updated/revised for 4th Edition compliance.  There are some definitions contained in the Medical Device Regulation such as 'making available on the market' or 'placing on the market' so while I do not think those definitions make it clear, there is a presumption the product is sold.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 09-Oct-2018 16:24
From: Anonymous Member
Subject: 60601-1-2 4th edition European Compliance

This message was posted by a user wishing to remain anonymous

Hi Everyone,

I am hoping that someone in the community might be able to help me out.

I understand that the deadline for 60601-1-2 4th edition for Europe, USA, and Canada is December 31, 2018.  Any new devices manufactured and sold to Europe, USA, and Canada must be compliant with the 4th edition after the deadline.

What is unclear to me is the following:  We have already sold some of our 3rd edition tested devices to distributors in the three countries listed above but they still have inventory on their shelves that they have not sold to customers in their respective countries.  Are the distributors allowed to sell those 3rd edition devices in their own country after the deadline or do we need to replace all of their inventory with 4th edition devices so that they can continue to sell after the deadline?

Thank you for your help!!

DS

Thank you for the comments Leo and do agree that transfer of ownership may not be financial if the capital equipment is under a lease or loaned where the company makes the revenue on the "razor blades" provided for the equipment, so can get a bit tricky.

I did have one clarification or discussion point on your last paragraph.  Completely agree that IEC 60601-1-2 4th Edition is needed when a new 510(k) premarket notification is made for a device through the FDA or a new Medical Device License (MDL) through Canada (post Dec 2018).  However, would not "state of the art" or Good Manufacturing Practices (GMP) be in place that companies should have their devices compliant (tested) to 4th Edition after 31 Dec 2018?  I could just imagine that an astute FDA investigator could challenge a company in mid-2019 or end-2019 if they have a device that has a 510(k) clearance from 2016 with no plans for a new 510(k) and only tested to 3rd Edition.  I might think that a challenge could be made if the currently manufactured devices are not compliant to 4th edition after end of 2018.  Thoughts?

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 11-Oct-2018 02:39
From: Leonard Eisner
Subject: 60601-1-2 4th edition European Compliance

I agree with Richard for the most part other than one issue for the EU which is the transfer of ownership does not need to end up in financial transfer as there are times when devices (capital equipment) are loaned to the end user and then the disposables are sold to the end user.

I had a question on IEC 60601-1-2, 4th ed last week focused on the EU so I am repeating below. 

          That is a good question and it depends.  If it is sold to the end user for sure that would be ok but if no transfer of ownership it starts being in a grey zone and I think you will need to look at the current EU blue guide & there is a 2010 document on placing on the market from the EU for Med devices for MDD & AIMDD.  I have attached the 2010 document just not sure if the most current or not.  I would be interested to know if the attached document is still relevant and being used or if there is a more recent document to use.

Note for the EU existing & new products that you sell into the EU will both need to <g class="gr_ gr_799 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar multiReplace" id="799" data-gr-id="799">upgraded</g> to EN 60601-1-2, 4th ed whereas for the US & Canada only the products that need to go thru a submission to the FDA & Health Canada will need to meet 4th ed.  So, if you have a legacy device that doesn't change for many years to come you don't need to meet 4th ed. for the US & Canada but for the EU you need to 4th ed for that same product.

To read more about the IEC 60601-1-2, 4th ed. and country expectations for the US, Canada, and the EU read this blog post.

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com

Original Message:
Sent: 10-Oct-2018 15:23
From: Anonymous Member
Subject: 60601-1-2 4th edition European Compliance

This message was posted by a user wishing to remain anonymous

Thank you very much Richard and Lauren.  I greatly appreciate your input!
Original Message:
Sent: 10-Oct-2018 07:39
From: Lauren Ziegler
Subject: 60601-1-2 4th edition European Compliance

I completely agree that once product has been sold and out of the legal manufacturer's possession, that it is "in the field" and can be sold by the distributor without concern for the new regulation to be implemented in 2019.

------------------------------
Lauren Ziegler RAC
Global Program, Regulatory Director
Montville NJ
United States

Original Message:
Sent: 10-Oct-2018 06:31
From: Richard Vincins
Subject: 60601-1-2 4th edition European Compliance

Hello,

I can give my interpretation, but others may have differing opinions and the individual country laws and regulations may have specific import or export requirements.  When the device(s) have left your facility, your possession, these are considered to be "placed on the market" because a distributor is a separate entity.  A material and financial transaction has occurred, so those devices that are compliant to 3rd Edition on a distributor's inventory location/shelf after 31 Dec 2018 would still be legally valid.  Meaning they would not need to be retrieved, reworked, or retested depending on any changes you had to make to the device from 3rd Edition to 4th Edition compliance (hopefully not much).  Now if this distributor is your own company, the warehouse or inventory an "extension" of manufacturing activities and storage, then they are still under your control and should be updated/revised for 4th Edition compliance.  There are some definitions contained in the Medical Device Regulation such as 'making available on the market' or 'placing on the market' so while I do not think those definitions make it clear, there is a presumption the product is sold.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 09-Oct-2018 16:24
From: Anonymous Member
Subject: 60601-1-2 4th edition European Compliance

This message was posted by a user wishing to remain anonymous

Hi Everyone,

I am hoping that someone in the community might be able to help me out.

I understand that the deadline for 60601-1-2 4th edition for Europe, USA, and Canada is December 31, 2018.  Any new devices manufactured and sold to Europe, USA, and Canada must be compliant with the 4th edition after the deadline.

What is unclear to me is the following:  We have already sold some of our 3rd edition tested devices to distributors in the three countries listed above but they still have inventory on their shelves that they have not sold to customers in their respective countries.  Are the distributors allowed to sell those 3rd edition devices in their own country after the deadline or do we need to replace all of their inventory with 4th edition devices so that they can continue to sell after the deadline?

Thank you for your help!!

DS

Richard,

<g class="gr_ gr_1534 gr-alert gr_gramm gr_inline_cards gr_run_anim Punctuation only-ins replaceWithoutSep" id="1534" data-gr-id="1534">Sorry</g> delayed response got caught up on project work and new projects opening up keeping me busy.

Interesting point about an astute investigator.  I really don't know the answer to that question that you pose.  

All, I know is that I have heard if you actually don't change your device at all for many years you don't have a requirement to do a 510(k) for FDA and similar for Health Canada.    But if you think of modern medical electrical equipment this is not a very realistic scenario as it is almost a physical impossibility nowadays because of <g class="gr_ gr_849 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar only-ins doubleReplace replaceWithoutSep" id="849" data-gr-id="849">end</g> of life issues for components, components that need to switch over for RoHS compliance and other requirements that keep changing components.  Therefore it is hard to keep a medical electrical device identical without any component or software/firmware or labeling changes for very long that a couple years down the road you would have a significant change (see FDA Guidances for Device changes or software/firmware changes) or a lot of little changes over time that build up to be considered significant change(s) in regulatory circles may be called a catch-up 510(k) (even though there is no such formal guidance or system for that term being used just common sense).

Those are my thoughts on this issue.  What are your thoughts <g class="gr_ gr_1442 gr-alert gr_gramm gr_inline_cards gr_run_anim Punctuation only-ins replaceWithoutSep" id="1442" data-gr-id="1442">Richard</g>?

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 11-Oct-2018 04:55
From: Richard Vincins
Subject: 60601-1-2 4th edition European Compliance

Thank you for the comments Leo and do agree that transfer of ownership may not be financial if the capital equipment is under a lease or loaned where the company makes the revenue on the "razor blades" provided for the equipment, so can get a bit tricky.

I did have one clarification or discussion point on your last paragraph.  Completely agree that IEC 60601-1-2 4th Edition is needed when a new 510(k) premarket notification is made for a device through the FDA or a new Medical Device License (MDL) through Canada (post Dec 2018).  However, would not "state of the art" or Good Manufacturing Practices (GMP) be in place that companies should have their devices compliant (tested) to 4th Edition after 31 Dec 2018?  I could just imagine that an astute FDA investigator could challenge a company in mid-2019 or end-2019 if they have a device that has a 510(k) clearance from 2016 with no plans for a new 510(k) and only tested to 3rd Edition.  I might think that a challenge could be made if the currently manufactured devices are not compliant to 4th edition after end of 2018.  Thoughts?

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 11-Oct-2018 02:39
From: Leonard Eisner
Subject: 60601-1-2 4th edition European Compliance

I agree with Richard for the most part other than one issue for the EU which is the transfer of ownership does not need to end up in financial transfer as there are times when devices (capital equipment) are loaned to the end user and then the disposables are sold to the end user.

I had a question on IEC 60601-1-2, 4th ed last week focused on the EU so I am repeating below. 

          That is a good question and it depends.  If it is sold to the end user for sure that would be ok but if no transfer of ownership it starts being in a grey zone and I think you will need to look at the current EU blue guide & there is a 2010 document on placing on the market from the EU for Med devices for MDD & AIMDD.  I have attached the 2010 document just not sure if the most current or not.  I would be interested to know if the attached document is still relevant and being used or if there is a more recent document to use.

Note for the EU existing & new products that you sell into the EU will both need to <g class="gr_ gr_799 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar multiReplace" id="799" data-gr-id="799">upgraded</g> to EN 60601-1-2, 4th ed whereas for the US & Canada only the products that need to go thru a submission to the FDA & Health Canada will need to meet 4th ed.  So, if you have a legacy device that doesn't change for many years to come you don't need to meet 4th ed. for the US & Canada but for the EU you need to 4th ed for that same product.

To read more about the IEC 60601-1-2, 4th ed. and country expectations for the US, Canada, and the EU read this blog post.

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com

Original Message:
Sent: 10-Oct-2018 15:23
From: Anonymous Member
Subject: 60601-1-2 4th edition European Compliance

This message was posted by a user wishing to remain anonymous

Thank you very much Richard and Lauren.  I greatly appreciate your input!
Original Message:
Sent: 10-Oct-2018 07:39
From: Lauren Ziegler
Subject: 60601-1-2 4th edition European Compliance

I completely agree that once product has been sold and out of the legal manufacturer's possession, that it is "in the field" and can be sold by the distributor without concern for the new regulation to be implemented in 2019.

------------------------------
Lauren Ziegler RAC
Global Program, Regulatory Director
Montville NJ
United States

Original Message:
Sent: 10-Oct-2018 06:31
From: Richard Vincins
Subject: 60601-1-2 4th edition European Compliance

Hello,

I can give my interpretation, but others may have differing opinions and the individual country laws and regulations may have specific import or export requirements.  When the device(s) have left your facility, your possession, these are considered to be "placed on the market" because a distributor is a separate entity.  A material and financial transaction has occurred, so those devices that are compliant to 3rd Edition on a distributor's inventory location/shelf after 31 Dec 2018 would still be legally valid.  Meaning they would not need to be retrieved, reworked, or retested depending on any changes you had to make to the device from 3rd Edition to 4th Edition compliance (hopefully not much).  Now if this distributor is your own company, the warehouse or inventory an "extension" of manufacturing activities and storage, then they are still under your control and should be updated/revised for 4th Edition compliance.  There are some definitions contained in the Medical Device Regulation such as 'making available on the market' or 'placing on the market' so while I do not think those definitions make it clear, there is a presumption the product is sold.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 09-Oct-2018 16:24
From: Anonymous Member
Subject: 60601-1-2 4th edition European Compliance

This message was posted by a user wishing to remain anonymous

Hi Everyone,

I am hoping that someone in the community might be able to help me out.

I understand that the deadline for 60601-1-2 4th edition for Europe, USA, and Canada is December 31, 2018.  Any new devices manufactured and sold to Europe, USA, and Canada must be compliant with the 4th edition after the deadline.

What is unclear to me is the following:  We have already sold some of our 3rd edition tested devices to distributors in the three countries listed above but they still have inventory on their shelves that they have not sold to customers in their respective countries.  Are the distributors allowed to sell those 3rd edition devices in their own country after the deadline or do we need to replace all of their inventory with 4th edition devices so that they can continue to sell after the deadline?

Thank you for your help!!

DS

The astute Investigator may not exist.

 

QSIT, in the narrative portion of Design Controls, Inspectional Objective #1, says, "Do not inspect a device under design control requirements to determine whether the design was appropriate or safe and effective. This is precluded under Section 520(f)(1)(A) of the Act. However, if based on information obtained during an evaluation of the firm's design controls, it appears that the device is unsafe or ineffective, then report those findings in the EIR."

 

I infer that this precludes an Investigator from considering whether an existing device complies with the most current standards. In other words, the Investigator should not write a 483 observation for failure to implement a design change because there is a newer version of a standard used in a 510(k) submission.

 

 

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

Original Message:
Sent: 11-Oct-2018 04:55
From: Richard Vincins
Subject: 60601-1-2 4th edition European Compliance

Thank you for the comments Leo and do agree that transfer of ownership may not be financial if the capital equipment is under a lease or loaned where the company makes the revenue on the "razor blades" provided for the equipment, so can get a bit tricky.

I did have one clarification or discussion point on your last paragraph.  Completely agree that IEC 60601-1-2 4th Edition is needed when a new 510(k) premarket notification is made for a device through the FDA or a new Medical Device License (MDL) through Canada (post Dec 2018).  However, would not "state of the art" or Good Manufacturing Practices (GMP) be in place that companies should have their devices compliant (tested) to 4th Edition after 31 Dec 2018?  I could just imagine that an astute FDA investigator could challenge a company in mid-2019 or end-2019 if they have a device that has a 510(k) clearance from 2016 with no plans for a new 510(k) and only tested to 3rd Edition.  I might think that a challenge could be made if the currently manufactured devices are not compliant to 4th edition after end of 2018.  Thoughts?

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 11-Oct-2018 02:39
From: Leonard Eisner
Subject: 60601-1-2 4th edition European Compliance

I agree with Richard for the most part other than one issue for the EU which is the transfer of ownership does not need to end up in financial transfer as there are times when devices (capital equipment) are loaned to the end user and then the disposables are sold to the end user.

I had a question on IEC 60601-1-2, 4th ed last week focused on the EU so I am repeating below. 

          That is a good question and it depends.  If it is sold to the end user for sure that would be ok but if no transfer of ownership it starts being in a grey zone and I think you will need to look at the current EU blue guide & there is a 2010 document on placing on the market from the EU for Med devices for MDD & AIMDD.  I have attached the 2010 document just not sure if the most current or not.  I would be interested to know if the attached document is still relevant and being used or if there is a more recent document to use.

Note for the EU existing & new products that you sell into the EU will both need to <g class="gr_ gr_799 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar multiReplace" id="799" data-gr-id="799">upgraded</g> to EN 60601-1-2, 4th ed whereas for the US & Canada only the products that need to go thru a submission to the FDA & Health Canada will need to meet 4th ed.  So, if you have a legacy device that doesn't change for many years to come you don't need to meet 4th ed. for the US & Canada but for the EU you need to 4th ed for that same product.

To read more about the IEC 60601-1-2, 4th ed. and country expectations for the US, Canada, and the EU read this blog post.

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com

Original Message:
Sent: 10-Oct-2018 15:23
From: Anonymous Member
Subject: 60601-1-2 4th edition European Compliance

This message was posted by a user wishing to remain anonymous

Thank you very much Richard and Lauren.  I greatly appreciate your input!
Original Message:
Sent: 10-Oct-2018 07:39
From: Lauren Ziegler
Subject: 60601-1-2 4th edition European Compliance

I completely agree that once product has been sold and out of the legal manufacturer's possession, that it is "in the field" and can be sold by the distributor without concern for the new regulation to be implemented in 2019.

------------------------------
Lauren Ziegler RAC
Global Program, Regulatory Director
Montville NJ
United States

Original Message:
Sent: 10-Oct-2018 06:31
From: Richard Vincins
Subject: 60601-1-2 4th edition European Compliance

Hello,

I can give my interpretation, but others may have differing opinions and the individual country laws and regulations may have specific import or export requirements.  When the device(s) have left your facility, your possession, these are considered to be "placed on the market" because a distributor is a separate entity.  A material and financial transaction has occurred, so those devices that are compliant to 3rd Edition on a distributor's inventory location/shelf after 31 Dec 2018 would still be legally valid.  Meaning they would not need to be retrieved, reworked, or retested depending on any changes you had to make to the device from 3rd Edition to 4th Edition compliance (hopefully not much).  Now if this distributor is your own company, the warehouse or inventory an "extension" of manufacturing activities and storage, then they are still under your control and should be updated/revised for 4th Edition compliance.  There are some definitions contained in the Medical Device Regulation such as 'making available on the market' or 'placing on the market' so while I do not think those definitions make it clear, there is a presumption the product is sold.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 09-Oct-2018 16:24
From: Anonymous Member
Subject: 60601-1-2 4th edition European Compliance

This message was posted by a user wishing to remain anonymous

Hi Everyone,

I am hoping that someone in the community might be able to help me out.

I understand that the deadline for 60601-1-2 4th edition for Europe, USA, and Canada is December 31, 2018.  Any new devices manufactured and sold to Europe, USA, and Canada must be compliant with the 4th edition after the deadline.

What is unclear to me is the following:  We have already sold some of our 3rd edition tested devices to distributors in the three countries listed above but they still have inventory on their shelves that they have not sold to customers in their respective countries.  Are the distributors allowed to sell those 3rd edition devices in their own country after the deadline or do we need to replace all of their inventory with 4th edition devices so that they can continue to sell after the deadline?

Thank you for your help!!

DS

Dear A:

The term "placing on the market" in EU has evolved. Refer to Blue Guide 2000 v. 2014 (published on July 26, 2016).

You state "We have already sold some of our 3rd edition tested devices to distributors in the three countries..."

In EU, are you referring to your Authorized Representative (AR)?  Please be noted that transferring from the manufacturer (M) in a third country to your AR in EU is not considered that a product is placed on the market. 

Per the Blue Guide 2014, "placing on the market" or "putting into services" should be interpreted to take place when a product is sold by the importer to a distributor or to the end user.  For example, if a product is on stock at the distributor's warehouse, the product has been already placed on the market and the ownership has been changed. 

In the US, if a distributor has to go out and install a device on site, the distributor is viewed as an extension of the manufacturer because the device is not a finished device unless and until it is installed and validated on site.

------------------------------
Dr. David Lim, Ph.D., RAC, ASQ-CQA
REGULATORY DOCTOR
------------------------------

Original Message:
Sent: 09-Oct-2018 16:24
From: Anonymous Member
Subject: 60601-1-2 4th edition European Compliance

This message was posted by a user wishing to remain anonymous

Hi Everyone,

I am hoping that someone in the community might be able to help me out.

I understand that the deadline for 60601-1-2 4th edition for Europe, USA, and Canada is December 31, 2018.  Any new devices manufactured and sold to Europe, USA, and Canada must be compliant with the 4th edition after the deadline.

What is unclear to me is the following:  We have already sold some of our 3rd edition tested devices to distributors in the three countries listed above but they still have inventory on their shelves that they have not sold to customers in their respective countries.  Are the distributors allowed to sell those 3rd edition devices in their own country after the deadline or do we need to replace all of their inventory with 4th edition devices so that they can continue to sell after the deadline?

Thank you for your help!!

DS

Leo that does make sense to me, though I just know in practice companies may go years of changing things without submitting a new 510(k).  I guess this is quite different in US/Canada versus EU where they may be looking at your technical documentation once a year or some period of time.  The wonderful world of regulatory compliance ! :)

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 18-Oct-2018 09:06
From: David Lim
Subject: 60601-1-2 4th edition European Compliance

Dear A:

The term "placing on the market" in EU has evolved. Refer to Blue Guide 2000 v. 2014 (published on July 26, 2016).

You state "We have already sold some of our 3rd edition tested devices to distributors in the three countries..."

In EU, are you referring to your Authorized Representative (AR)?  Please be noted that transferring from the manufacturer (M) in a third country to your AR in EU is not considered that a product is placed on the market.

Per the Blue Guide 2014, "placing on the market" or "putting into services" should be interpreted to take place when a product is sold by the importer to a distributor or to the end user.  For example, if a product is on stock at the distributor's warehouse, the product has been already placed on the market and the ownership has been changed.

In the US, if a distributor has to go out and install a device on site, the distributor is viewed as an extension of the manufacturer because the device is not a finished device unless and until it is installed and validated on site.

------------------------------
Dr. David Lim, Ph.D., RAC, ASQ-CQA
REGULATORY DOCTOR

Original Message:
Sent: 09-Oct-2018 16:24
From: Anonymous Member
Subject: 60601-1-2 4th edition European Compliance

This message was posted by a user wishing to remain anonymous

Hi Everyone,

I am hoping that someone in the community might be able to help me out.

I understand that the deadline for 60601-1-2 4th edition for Europe, USA, and Canada is December 31, 2018.  Any new devices manufactured and sold to Europe, USA, and Canada must be compliant with the 4th edition after the deadline.

What is unclear to me is the following:  We have already sold some of our 3rd edition tested devices to distributors in the three countries listed above but they still have inventory on their shelves that they have not sold to customers in their respective countries.  Are the distributors allowed to sell those 3rd edition devices in their own country after the deadline or do we need to replace all of their inventory with 4th edition devices so that they can continue to sell after the deadline?

Thank you for your help!!

DS

Hi
I completely agree with Richard´s interpretation.

BR
Evangelos
CE marking auditor/ ISO auditor

------------------------------
Evangelos Tavandzis
Praha
Czech Republic
------------------------------

Original Message:
Sent: 09-Oct-2018 16:24
From: Anonymous Member
Subject: 60601-1-2 4th edition European Compliance

This message was posted by a user wishing to remain anonymous

Hi Everyone,

I am hoping that someone in the community might be able to help me out.

I understand that the deadline for 60601-1-2 4th edition for Europe, USA, and Canada is December 31, 2018.  Any new devices manufactured and sold to Europe, USA, and Canada must be compliant with the 4th edition after the deadline.

What is unclear to me is the following:  We have already sold some of our 3rd edition tested devices to distributors in the three countries listed above but they still have inventory on their shelves that they have not sold to customers in their respective countries.  Are the distributors allowed to sell those 3rd edition devices in their own country after the deadline or do we need to replace all of their inventory with 4th edition devices so that they can continue to sell after the deadline?

Thank you for your help!!

DS

I agree with Dan's interpretation for the US that said:

"QSIT, in the narrative portion of Design Controls, Inspectional Objective #1, says, "Do not inspect a device under design control requirements to determine whether the design was appropriate or safe and effective. This is precluded under Section 520(f)(1)(A) of the Act<g class="gr_ gr_98 gr-alert gr_gramm gr_inline_cards gr_run_anim Punctuation multiReplace" id="98" data-gr-id="98">....</g>

I infer that this precludes an Investigator from considering whether an existing device complies with the most current standards. In other words, the Investigator should not write a 483 observation for failure to implement a design change because there is a newer version of a standard used in a 510(k) submission."

This is the way I have understood the FDA process you do a regulatory submission to the current Recognized Consensus Standards (Voluntary but <g class="gr_ gr_204 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar only-ins doubleReplace replaceWithoutSep" id="204" data-gr-id="204">easiest</g> path) & applicable Guidances (Voluntary too).  Then as I have said for years now: "You can sit pretty for many many years if you have no changes that impact the submission." as you won't have to resubmit to the Agency.  I have understood this to be the same for Canada.  There is also a Canadian Notice from 2016 that says if there is no Canadian Guidance for Pre Market Submission you can rely on the US <g class="gr_ gr_818 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del multiReplace" id="818" data-gr-id="818">FDAs</g> Guidance but Health Canada does have a Significant Change Guidance of their own.

To read more about the IEC 60601-1-2, 4th ed. and country expectations for the US, Canada, and the EU read this blog post.

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 20-Oct-2018 04:11
From: Evangelos Tavandzis
Subject: 60601-1-2 4th edition European Compliance

Hi
I completely agree with Richard´s interpretation.

BR
Evangelos
CE marking auditor/ ISO auditor

------------------------------
Evangelos Tavandzis
Praha
Czech Republic

Original Message:
Sent: 09-Oct-2018 16:24
From: Anonymous Member
Subject: 60601-1-2 4th edition European Compliance

This message was posted by a user wishing to remain anonymous

Hi Everyone,

I am hoping that someone in the community might be able to help me out.

I understand that the deadline for 60601-1-2 4th edition for Europe, USA, and Canada is December 31, 2018.  Any new devices manufactured and sold to Europe, USA, and Canada must be compliant with the 4th edition after the deadline.

What is unclear to me is the following:  We have already sold some of our 3rd edition tested devices to distributors in the three countries listed above but they still have inventory on their shelves that they have not sold to customers in their respective countries.  Are the distributors allowed to sell those 3rd edition devices in their own country after the deadline or do we need to replace all of their inventory with 4th edition devices so that they can continue to sell after the deadline?

Thank you for your help!!

DS

Another thing you may want to consider is looking at which version of the EMC standard your Particular Standard "Dash-two" states you must comply. Your EN 60601-2-xx standard may specify exactly which version of the EMC standard to use (and it may be the earlier one).

------------------------------
Michael Preto
OH, United States
------------------------------

Original Message:
Sent: 09-Oct-2018 16:24
From: Anonymous Member
Subject: 60601-1-2 4th edition European Compliance

This message was posted by a user wishing to remain anonymous

Hi Everyone,

I am hoping that someone in the community might be able to help me out.

I understand that the deadline for 60601-1-2 4th edition for Europe, USA, and Canada is December 31, 2018.  Any new devices manufactured and sold to Europe, USA, and Canada must be compliant with the 4th edition after the deadline.

What is unclear to me is the following:  We have already sold some of our 3rd edition tested devices to distributors in the three countries listed above but they still have inventory on their shelves that they have not sold to customers in their respective countries.  Are the distributors allowed to sell those 3rd edition devices in their own country after the deadline or do we need to replace all of their inventory with 4th edition devices so that they can continue to sell after the deadline?

Thank you for your help!!

DS

Hi Michael,

Yes, that may be true but if your Particular standard 60601-2-XX or 80601-2-XX points you to an earlier 60601-1-2 you have a problem with FDA and other regulators at the end of this year as you will have to show how using the older standard covers all the risk that the more current standard covers.  There was a CDRH learn event today on Recognized Consensus standards and that was a question I asked in relation to Normative standards referenced in IEC 60601-2-18 which the Recognized Consensus standard is dated 2009 so it aligns with IEC 60601-1, 3rd ed. but the FDA doesn't Recognize 3rd ed. anymore just edition 3.1.  So, a gap analysis needs to be done showing how you either meet the newer requirements if there are new risks or concerns to be considered.  It gets messy because this Particular standard references many older standards (such as IEC 60601-1, 60601-1-2, 60601-2-2).  

Michael said the below for those that don't want to look back:

Another thing you may want to consider is looking at which version of the EMC standard your Particular Standard "Dash-two" states you must comply. Your EN 60601-2-xx standard may specify exactly which version of the EMC standard to use (and it may be the earlier one).


------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 22-Oct-2018 09:52
From: Michael Preto
Subject: 60601-1-2 4th edition European Compliance

Another thing you may want to consider is looking at which version of the EMC standard your Particular Standard "Dash-two" states you must comply. Your EN 60601-2-xx standard may specify exactly which version of the EMC standard to use (and it may be the earlier one).

------------------------------
Michael Preto
OH, United States

Original Message:
Sent: 09-Oct-2018 16:24
From: Anonymous Member
Subject: 60601-1-2 4th edition European Compliance

This message was posted by a user wishing to remain anonymous

Hi Everyone,

I am hoping that someone in the community might be able to help me out.

I understand that the deadline for 60601-1-2 4th edition for Europe, USA, and Canada is December 31, 2018.  Any new devices manufactured and sold to Europe, USA, and Canada must be compliant with the 4th edition after the deadline.

What is unclear to me is the following:  We have already sold some of our 3rd edition tested devices to distributors in the three countries listed above but they still have inventory on their shelves that they have not sold to customers in their respective countries.  Are the distributors allowed to sell those 3rd edition devices in their own country after the deadline or do we need to replace all of their inventory with 4th edition devices so that they can continue to sell after the deadline?

Thank you for your help!!

DS

@Leonard: That is ​good intel on the CDRH event. And I do agree every regulator may not accept this rationale. However, in this thread the market discussed is EU. Its worth a conversation with your NB if the OJEU indicates a version of your particular standard that has a normative reference to the earlier EMC standard.

------------------------------
Michael Preto
Cleveland OH
United States
------------------------------

Original Message:
Sent: 25-Oct-2018 22:12
From: Leonard Eisner
Subject: 60601-1-2 4th edition European Compliance

Hi Michael,

Yes, that may be true but if your Particular standard 60601-2-XX or 80601-2-XX points you to an earlier 60601-1-2 you have a problem with FDA and other regulators at the end of this year as you will have to show how using the older standard covers all the risk that the more current standard covers.  There was a CDRH learn event today on Recognized Consensus standards and that was a question I asked in relation to Normative standards referenced in IEC 60601-2-18 which the Recognized Consensus standard is dated 2009 so it aligns with IEC 60601-1, 3rd ed. but the FDA doesn't Recognize 3rd ed. anymore just edition 3.1.  So, a gap analysis needs to be done showing how you either meet the newer requirements if there are new risks or concerns to be considered.  It gets messy because this Particular standard references many older standards (such as IEC 60601-1, 60601-1-2, 60601-2-2).

Michael said the below for those that don't want to look back:

Another thing you may want to consider is looking at which version of the EMC standard your Particular Standard "Dash-two" states you must comply. Your EN 60601-2-xx standard may specify exactly which version of the EMC standard to use (and it may be the earlier one).


------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com

Original Message:
Sent: 22-Oct-2018 09:52
From: Michael Preto
Subject: 60601-1-2 4th edition European Compliance

Another thing you may want to consider is looking at which version of the EMC standard your Particular Standard "Dash-two" states you must comply. Your EN 60601-2-xx standard may specify exactly which version of the EMC standard to use (and it may be the earlier one).

------------------------------
Michael Preto
OH, United States

Original Message:
Sent: 09-Oct-2018 16:24
From: Anonymous Member
Subject: 60601-1-2 4th edition European Compliance

This message was posted by a user wishing to remain anonymous

Hi Everyone,

I am hoping that someone in the community might be able to help me out.

I understand that the deadline for 60601-1-2 4th edition for Europe, USA, and Canada is December 31, 2018.  Any new devices manufactured and sold to Europe, USA, and Canada must be compliant with the 4th edition after the deadline.

What is unclear to me is the following:  We have already sold some of our 3rd edition tested devices to distributors in the three countries listed above but they still have inventory on their shelves that they have not sold to customers in their respective countries.  Are the distributors allowed to sell those 3rd edition devices in their own country after the deadline or do we need to replace all of their inventory with 4th edition devices so that they can continue to sell after the deadline?

Thank you for your help!!

DS

This message was posted by a user wishing to remain anonymous

Does anyone now whether the Australian TGA has any specific requirements or compliance date for IEC 60601-1-2 4th edition?
Original Message:
Sent: 09-Oct-2018 16:24
From: Anonymous Member
Subject: 60601-1-2 4th edition European Compliance

This message was posted by a user wishing to remain anonymous

Hi Everyone,

I am hoping that someone in the community might be able to help me out.

I understand that the deadline for 60601-1-2 4th edition for Europe, USA, and Canada is December 31, 2018.  Any new devices manufactured and sold to Europe, USA, and Canada must be compliant with the 4th edition after the deadline.

What is unclear to me is the following:  We have already sold some of our 3rd edition tested devices to distributors in the three countries listed above but they still have inventory on their shelves that they have not sold to customers in their respective countries.  Are the distributors allowed to sell those 3rd edition devices in their own country after the deadline or do we need to replace all of their inventory with 4th edition devices so that they can continue to sell after the deadline?

Thank you for your help!!

DS

I have an issue that has had much discussion at one of my clients.  They have devices with a lifetime warranty so devices will be returned to the manufacturer for repair/refurbishment.

Some hospitals want their exact device returned to them after repair.  Can these devices be returned to hospitals or physicians in Europe without meeting the requirements of IEC 60601-2 4th edition?

This company also receives units from customers that don't request their exact units back.  They receive a refurbished device back.  Would these units be able to be sent to Europe without meeting the requirements of IEC 60601-2 4th edition?

Thanks.

------------------------------
Susan Hamann RAC, FRAPS
President
Hamann QR Consulting
Middletown, DE
USA
------------------------------

Original Message:
Sent: 27-Nov-2018 12:12
From: Anonymous Member
Subject: 60601-1-2 4th edition European Compliance

This message was posted by a user wishing to remain anonymous

Does anyone now whether the Australian TGA has any specific requirements or compliance date for IEC 60601-1-2 4th edition?
Original Message:
Sent: 09-Oct-2018 16:24
From: Anonymous Member
Subject: 60601-1-2 4th edition European Compliance

This message was posted by a user wishing to remain anonymous

Hi Everyone,

I am hoping that someone in the community might be able to help me out.

I understand that the deadline for 60601-1-2 4th edition for Europe, USA, and Canada is December 31, 2018.  Any new devices manufactured and sold to Europe, USA, and Canada must be compliant with the 4th edition after the deadline.

What is unclear to me is the following:  We have already sold some of our 3rd edition tested devices to distributors in the three countries listed above but they still have inventory on their shelves that they have not sold to customers in their respective countries.  Are the distributors allowed to sell those 3rd edition devices in their own country after the deadline or do we need to replace all of their inventory with 4th edition devices so that they can continue to sell after the deadline?

Thank you for your help!!

DS