Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Main Question:

• Do Class I medical devices require an expiration date?

Without trying to sway anyone's answer, I'm of the opinion that Class I med. devs do NOT require one. Part of my rationale for this is that Class I devices do not require dynamic UDIs (i.e. the PI portion). Furthermore, I cannot find anything definitive published by the FDA (21 CFR Part 800 - 898, guidance docs, etc.) on this matter.

All-in-all, I am by no means any kind of expert and can be wrong on one or multiple things I've stated above. Any information that can be provided is appreciated.

Any device can have an expiration date; its device class is irrelevant, as is the part of the UDI regulation stating that Class I devices are not required to have production identifiers (PIs). A manufacturer can choose to include the PI information on Class I devices.

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Lena Cordie
Victoria MN
United States
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Original Message:
Sent: 08-Jan-2019 09:41
From: Anonymous Member
Subject: Class I Med. Devs & Expiration Dates

This message was posted by a user wishing to remain anonymous

Main Question:

• Do Class I medical devices require an expiration date?

Without trying to sway anyone's answer, I'm of the opinion that Class I med. devs do NOT require one. Part of my rationale for this is that Class I devices do not require dynamic UDIs (i.e. the PI portion). Furthermore, I cannot find anything definitive published by the FDA (21 CFR Part 800 - 898, guidance docs, etc.) on this matter.

All-in-all, I am by no means any kind of expert and can be wrong on one or multiple things I've stated above. Any information that can be provided is appreciated.

The MDR states that:

UDI-PI
The UDI-PI is a numeric or alphanumeric code that identifies the unit of device production. The different types of UDI-PIs include serial number, lot number, software identification and manufacturing or expiry date or both types of date.

To me, it is clear that in low risk products, such as Class I devices, you can go with manufacturing date only. But if it is a product, which has a shelf life less than 2.5 years, its better to indicate the expiration date.

Hope that helps

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Spyros Drivelos
Medical Devices Manager
Agia Paraskevi, Athens
Greece
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Original Message:
Sent: 08-Jan-2019 09:41
From: Anonymous Member
Subject: Class I Med. Devs & Expiration Dates

This message was posted by a user wishing to remain anonymous

Main Question:

• Do Class I medical devices require an expiration date?

Without trying to sway anyone's answer, I'm of the opinion that Class I med. devs do NOT require one. Part of my rationale for this is that Class I devices do not require dynamic UDIs (i.e. the PI portion). Furthermore, I cannot find anything definitive published by the FDA (21 CFR Part 800 - 898, guidance docs, etc.) on this matter.

All-in-all, I am by no means any kind of expert and can be wrong on one or multiple things I've stated above. Any information that can be provided is appreciated.

To my knowledge

For all medical devices is required to have determinate lifetime in the whole life cycles  of MD  as is mentioned  in the new MDR or risk management standard ISO 14971 or PMS

Lifetime:  we can define as  " number or period of subsequent use  of MD"

Lifetime can be include both expiration date (shef life)  and  number or period of subsequent use  of MD

Evangelos Tavandzis
Consultant (lead auditor of mD
Prague
CZzech Republic

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

Original Message:
Sent: 08-Jan-2019 09:41
From: Anonymous Member
Subject: Class I Med. Devs & Expiration Dates

This message was posted by a user wishing to remain anonymous

Main Question:

• Do Class I medical devices require an expiration date?

Without trying to sway anyone's answer, I'm of the opinion that Class I med. devs do NOT require one. Part of my rationale for this is that Class I devices do not require dynamic UDIs (i.e. the PI portion). Furthermore, I cannot find anything definitive published by the FDA (21 CFR Part 800 - 898, guidance docs, etc.) on this matter.

All-in-all, I am by no means any kind of expert and can be wrong on one or multiple things I've stated above. Any information that can be provided is appreciated.

The expiration date or shelf life assigned to a finished medical device is irrelevant for the classification of device.  This needs to be determined by the medical device manufacturer based on type of finished device and if this is required.  There is also a distinction between lifetime of device, usable life of device, expiration date, and shelf life.  This should all be part of the design control input that is determined and verified or validated by the manufacturer.  Not all devices have an expiration or shelf life either as it may not be appropriate or has no impact on the degradation, functionality, or storage of device.  FDA would not publish any guidance, recommendation, or statement on devices that have or do not have expiration or shelf life - this is left up to the medical device manufacturer.  They do have some guidance for testing expiration or shelf life through storage or transport but companies need to determine whether their device has an applicable shelf life or expiration date.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 09-Jan-2019 05:45
From: Evangelos Tavandzis
Subject: Class I Med. Devs & Expiration Dates

To my knowledge

For all medical devices is required to have determinate lifetime in the whole life cycles  of MD  as is mentioned  in the new MDR or risk management standard ISO 14971 or PMS

Lifetime:  we can define as  " number or period of subsequent use  of MD"

Lifetime can be include both expiration date (shef life)  and  number or period of subsequent use  of MD

Evangelos Tavandzis
Consultant (lead auditor of mD
Prague
CZzech Republic

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

Original Message:
Sent: 08-Jan-2019 09:41
From: Anonymous Member
Subject: Class I Med. Devs & Expiration Dates

This message was posted by a user wishing to remain anonymous

Main Question:

• Do Class I medical devices require an expiration date?

Without trying to sway anyone's answer, I'm of the opinion that Class I med. devs do NOT require one. Part of my rationale for this is that Class I devices do not require dynamic UDIs (i.e. the PI portion). Furthermore, I cannot find anything definitive published by the FDA (21 CFR Part 800 - 898, guidance docs, etc.) on this matter.

All-in-all, I am by no means any kind of expert and can be wrong on one or multiple things I've stated above. Any information that can be provided is appreciated.