Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​Dear Community,

Hope someone can directe me to relevant reference. We are looking at extending the Expected Service Life of one of our Class II (USA) 510k exempt device and, need to identify if Model No of device will have to be changed to or if we can keep the same as long as the IFU now states that the service life is expected to X. This improvement will also be implemented in EU, Australia, Brazil and Canada so, any inputs on applicable regulations will be much appreciated.

I thank you all in advance!

Hello anon,

Much to my dismay there is not nor has been either a regulation or even a well put together guidance document on life of the product.  As can be expected because there are some many different medical devices out there, defining this would actually be a monumental task for most regulators.  When we talk about the lifecycle of a device there are many parameters including shelf life, usable life, expiration date, service life, marketing life, with a couple others.  In your specific example of extended the service life of your device, this is typically documented internally through either change management or design control changes depending on the impact of this service life time period.  It is very important the service life, life of the product, usable life of the product is defined for a product.  This sets the criteria for many other activities such as customer complaints, service periods, and discontinuation of products.  In my experience, most extension of service life or shelf life is usually documented internally and does not need a regulatory notification (which in your case is 510(k) Exempt so no action there).  I would just like to put out you need to look at Configuration Management from the perspective if you have different models or versions of a device out there with different service life criteria, this needs to be managed.  Service life can get quite complicated for electromechanical and similar devices when hardware is changing, software is changing, and new models introduced.  From a post market perspective, the organisation needs to keep track of these different version on the market, so if the service life is expected to be 'X' for some products and then 'Y' after a point in time, this needs to be understood when the change occurs.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 10-Dec-2019 17:10
From: Anonymous Member
Subject: Expected Service Life

This message was posted by a user wishing to remain anonymous

​Dear Community,

Hope someone can directe me to relevant reference. We are looking at extending the Expected Service Life of one of our Class II (USA) 510k exempt device and, need to identify if Model No of device will have to be changed to or if we can keep the same as long as the IFU now states that the service life is expected to X. This improvement will also be implemented in EU, Australia, Brazil and Canada so, any inputs on applicable regulations will be much appreciated.

I thank you all in advance!

In IEC 60601-1:2005 + A1:2012 the standard for medical electrical equipment (if that is the type of equipment you are talking about) the standard has a definition for Expected Service life in clause 3.28.  Which is "time period specified by the MANUFACTURER during which the ME EQUIPMENT or ME SYSTEM is expected to remain safe for use (i.e. maintain BASIC SAFETY and ESSENTIAL PERFORMANCE)"  Words in ALL CAPS are defined terms in the standard.  This standard is used by all the countries mentioned in your message.

------------------------------
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-Dec-2019 17:10
From: Anonymous Member
Subject: Expected Service Life

This message was posted by a user wishing to remain anonymous

​Dear Community,

Hope someone can directe me to relevant reference. We are looking at extending the Expected Service Life of one of our Class II (USA) 510k exempt device and, need to identify if Model No of device will have to be changed to or if we can keep the same as long as the IFU now states that the service life is expected to X. This improvement will also be implemented in EU, Australia, Brazil and Canada so, any inputs on applicable regulations will be much appreciated.

I thank you all in advance!

Hello anon,

If your medical device is electrical medical device you are responsible from IEC 60601-1 standart and the standart want to add this information into the IFU. 

"7.4.8 Additional requirements for maintenance
In addition to the requirements of 7.9.2.13 of the general standard the instructions for use
shall include:
– the EXPECTED SERVICE LIFE of the ME EQUIPMENT;
– the EXPECTED SERVICE LIFE of parts or ACCESSORIES shipped with the ME EQUIPMENT; and
– where the SHELF LIFE is less than the EXPECTED SERVICE LIFE, the SHELF LIFE of parts or
ACCESSORIES shipped with the ME EQUIPMENT.
Compliance is checked by inspection of the instructions for use."

I hope this informationwill help you.

Best wishes.

------------------------------
özge demir
Product Reliability Engineer
Alexandria VA
United States
------------------------------

Original Message:
Sent: 10-Dec-2019 17:10
From: Anonymous Member
Subject: Expected Service Life

This message was posted by a user wishing to remain anonymous

​Dear Community,

Hope someone can directe me to relevant reference. We are looking at extending the Expected Service Life of one of our Class II (USA) 510k exempt device and, need to identify if Model No of device will have to be changed to or if we can keep the same as long as the IFU now states that the service life is expected to X. This improvement will also be implemented in EU, Australia, Brazil and Canada so, any inputs on applicable regulations will be much appreciated.

I thank you all in advance!

The first question is how you arrived at the decision to extend the Expected Service Life. There are three ways, it seems, this could happen.
You analyzed the data and can demonstrate that the life is actually longer than your initial estimate
You made changes to the device that improve its life
The life remains the same and management has determined to achieve a competitive advantage by extending the life and absorbing the extra cost

The easiest way to answer the new model number question is to use the rule for a new UDI-DI in the US. A version or model is defined by a set of characteristics. You need a new UDI-DI if there are device changes that go outside the version or model definition.

My rule of thumb, not the regulation, is that if the customer would think the device is different, then it needs a new UDI-DI.

In the case of design changes that improve life, determine if the changes also affect the way the user perceives the device. In the other cases (analysis and management) the device has not changed, so no need for a new UDI-DI or model number.

Note however, that if you decide to change the model number, then the US rules requires a new UDI-DI, which means a new entry in GUDID.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 10-Dec-2019 17:10
From: Anonymous Member
Subject: Expected Service Life

This message was posted by a user wishing to remain anonymous

​Dear Community,

Hope someone can directe me to relevant reference. We are looking at extending the Expected Service Life of one of our Class II (USA) 510k exempt device and, need to identify if Model No of device will have to be changed to or if we can keep the same as long as the IFU now states that the service life is expected to X. This improvement will also be implemented in EU, Australia, Brazil and Canada so, any inputs on applicable regulations will be much appreciated.

I thank you all in advance!