Hello Martina,
Sorry, missed this thread in my email. If the device is not sterile, a "shelf life" really depends on if there are any components which deteriorate over time. As an example, I worked for a company we made a catheter which had a gel interface. The device was non-sterile, but it had a 3 year shelf life because we knew after about 3.8 years the gel would start drying out from transmission in the packaging. Another example is examination gloves which are non-sterile or condoms often have a shelf life because the plastic can deteriorate over time.
In most cases, if there is nothing in the device which degrades you do not need to perform shelf life. It would be recommended to still have some justification written in the technical documentation supporting why there is no shelf life. Just remember today the expectation is any medical device has a life of device established even if this may be for a long period of time.
My personal thought is shelf life when a device does not degrade should be supported through performance testing, such as bench performance testing or scientific review of the materials. In practical terms, most medical devices which do not have a shelf life is fairly well understood - again it is more about the life of the device which may need to be established.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
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Original Message:
Sent: 20-May-2021 08:33
From: Martina Danesi
Subject: EU MDR - Shelf Life of medical devices
Dear Richard,
thank you for your reply. I have a few follow up questions: what if the device is not sterile?
If the device does not degrade over time can it be a sufficient justification to not perform shelf-life testing?
Can we prove that the device does not degrade over time through PMS data (clinical safe history) or literature review? Which method would be best regarded?
Thank you very much,
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Martina Danesi
Regulatory Affairs Intern
RA-SCR Benelux
Philips Medical Systems Nederland B.V.
martina.danesi@philips.com
Original Message:
Sent: 20-May-2021 07:29
From: Richard Vincins
Subject: EU MDR - Shelf Life of medical devices
Hello Martina,
The shelf life depends alot on type of device considering whether there are components which degrade over time or materials which do not perform consistently after some period of time, i.e. plastics or electronic components. Also in most cases, products which are sterilised have a shelf life for the sterile packaging barrier system which is validated through storage, handling, and temperature conditions. I would say there is no criteria established for what gets shelf life testing or not, because as industry GMP sterile devices are expected to have a shelf life and it is up to the company determining whether shelf life applies to their device or components of their device. It is not mandatory for all medical devices as there are many which do not have a shelf life or expiration date because of the reason previously stated. Generally, similar types of devices on the market would indicate whether shelf life would be required.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
Original Message:
Sent: 19-May-2021 08:29
From: Ed Panek
Subject: EU MDR - Shelf Life of medical devices
Here is what we did.
1) Estimated shelf life based on an analysis of components, storage environment, energy drainage, and use environment
2) Arhennius testing to see how the device is still capable of meeting its claims in accelerated aging and finally;
3) Real-life sample aging testing to determine real shelf life.
You probably want to also have a shelf life testing plan that prepares samples for 1, 2 up to N years of real-time aged samples performance.
Regulatory agencies expect you to perform identical testing for each stage.
Ed
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Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
Original Message:
Sent: 19-May-2021 07:21
From: Martina Danesi
Subject: EU MDR - Shelf Life of medical devices
Dear all,
I would like to get an insight regarding the EU MDR guidelines for medical devices shelf life.
According to EU MDR 2017/745 Annex II, subsection 6.1 "detailed information regarding test design, complete test or study protocols, methods of data analysis, in addition to data summaries and test conclusions regarding in particular… stability, including shelf life. Where no new testing has been undertaken, the documentation shall incorporate a rationale for that decision".
My question is:
is there any criteria to determine whether shelf life testing (or a rationale to not test) is required for medical devices? Or is shelf life a mandatory requirement for all medical devices?
Please note that my question refers to the device shelf life and not life time.
Thanks in advance for your response,
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Martina Danesi
Regulatory Affairs Intern
RA-SCR Benelux
Philips Medical Systems Nederland B.V.
martina.danesi@philips.com
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