Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Good morning everybody, 

Thank you for including me in this forum.

I'd like to ask the experts on this forum today with a label-related question. As part of an inspection by an competent authority in a hospital in Germany, the labeling of our products was questioned.

We are placing non-sterile products of risk class 1 for single use (lanryngoscope - spatula) on the market. The authority complains that the products are labeled without specifying a shelf life. From our point of view, this is not necessary for non-sterile products (single use).

I would like to know if this question has already been discussed in a similar way?

Thank you very much for your help in advance!

The question of shelf life is not related to the class, but to device characteristics that deteriorate over time such that at some point, the an important device characteristic goes out of specification.

Most devices don't have a shelf-life.

However, under the EU-MDR Annex I(23.2(j)) where there is no indication of the date until when it may be used safely, the date of manufacture. If your label doesn't have a date of manufacture, then the CA could infer that it has a shelf life.

It would be great if you were to provide the text of the CA complaint in English

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

Original Message:
Sent: 21-Jan-2022 04:02
From: Anonymous Member
Subject: Labeling of shelf life for non-sterile class 1 medical products

This message was posted by a user wishing to remain anonymous

Good morning everybody,

Thank you for including me in this forum.

I'd like to ask the experts on this forum today with a label-related question. As part of an inspection by an competent authority in a hospital in Germany, the labeling of our products was questioned.

We are placing non-sterile products of risk class 1 for single use (lanryngoscope - spatula) on the market. The authority complains that the products are labeled without specifying a shelf life. From our point of view, this is not necessary for non-sterile products (single use).

I would like to know if this question has already been discussed in a similar way?

Thank you very much for your help in advance!

The EU MDR does not unilaterally demand that the device label indicate the time limit for using the device (a.k.a., a "shelf life", "expiration date", etc.). This liberty is a fundamental provision of EU MDR Annex I.23.2(i).  Moreover, that provision is from the longstanding precedent brought in from the sunsetting MDD.

Accordingly, if a Competent Authority (CA) universally demands a shelf life regardless of device type or risk, then that would legislatively conflict with EU MDR Annex I.23.2(i).  Perhaps the CA is attempting to assert a regional requirement; it would be good for you to question the CA accordingly to learn its basis.

Also noteworthy is that the Notified Bodies traditionally under the MDD (see NB-MED/2.2/Rec3) echoed this liberty, stating that, except for active implantables, a shelf life was generally required only where a safety-related characteristic or claimed performance is likely to deteriorate over time.  As far as I know under the EU MDR, the NBs haven't departed from this sensible approach.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 21-Jan-2022 04:02
From: Anonymous Member
Subject: Labeling of shelf life for non-sterile class 1 medical products

This message was posted by a user wishing to remain anonymous

Good morning everybody,

Thank you for including me in this forum.

I'd like to ask the experts on this forum today with a label-related question. As part of an inspection by an competent authority in a hospital in Germany, the labeling of our products was questioned.

We are placing non-sterile products of risk class 1 for single use (lanryngoscope - spatula) on the market. The authority complains that the products are labeled without specifying a shelf life. From our point of view, this is not necessary for non-sterile products (single use).

I would like to know if this question has already been discussed in a similar way?

Thank you very much for your help in advance!

This message was posted by a user wishing to remain anonymous

Dear RA colleagues, Thank you for your valuable input. We are now in contact with the authorities and are trying to find out whether it is an official request or "just" a question. Perhaps those involved were not sufficiently aware that these were non-sterile products.

We will argue that we, as the manufacturer of the products, see no need to label the products with an indication of a shelf life.

Thank you for your quick support!

Original Message:
Sent: 21-Jan-2022 04:02
From: Anonymous Member
Subject: Labeling of shelf life for non-sterile class 1 medical products

This message was posted by a user wishing to remain anonymous

Good morning everybody,

Thank you for including me in this forum.

I'd like to ask the experts on this forum today with a label-related question. As part of an inspection by an competent authority in a hospital in Germany, the labeling of our products was questioned.

We are placing non-sterile products of risk class 1 for single use (lanryngoscope - spatula) on the market. The authority complains that the products are labeled without specifying a shelf life. From our point of view, this is not necessary for non-sterile products (single use).

I would like to know if this question has already been discussed in a similar way?

Thank you very much for your help in advance!

Sounds like a good plan.  And don't forget that if there is no expiration date on the label, then the label must instead bear the date of manufacture.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 24-Jan-2022 09:21
From: Anonymous Member
Subject: Labeling of shelf life for non-sterile class 1 medical products

This message was posted by a user wishing to remain anonymous

Dear RA colleagues, Thank you for your valuable input. We are now in contact with the authorities and are trying to find out whether it is an official request or "just" a question. Perhaps those involved were not sufficiently aware that these were non-sterile products.

We will argue that we, as the manufacturer of the products, see no need to label the products with an indication of a shelf life.

Thank you for your quick support!

Original Message:
Sent: 21-Jan-2022 04:02
From: Anonymous Member
Subject: Labeling of shelf life for non-sterile class 1 medical products

This message was posted by a user wishing to remain anonymous

Good morning everybody,

Thank you for including me in this forum.

I'd like to ask the experts on this forum today with a label-related question. As part of an inspection by an competent authority in a hospital in Germany, the labeling of our products was questioned.

We are placing non-sterile products of risk class 1 for single use (lanryngoscope - spatula) on the market. The authority complains that the products are labeled without specifying a shelf life. From our point of view, this is not necessary for non-sterile products (single use).

I would like to know if this question has already been discussed in a similar way?

Thank you very much for your help in advance!