Regulatory Open Forum

Dear community,

My apologizes if the topic has already been discussed, but i could not found a clear response.

EU MDR GSPR 23.3 refers to information that shall appear on the "sterile packaging". 23.3 (h) refers to "month and year of manufacture" and 23.3 (i) refers to "use by date".

Q1) Is it mandatory to address both (manufacturing date AND use-by-date) on the sterile packaging?

or like on 23.2(j) Information on the label, we can use either "the date until when may be used safely" or "the date of manufacture". 

Thanks in advance for your comments

BR

ik

Hello Iker,

Unfortunately, the EU MDR/IVDR are not precise in quite a few areas.  There are some who would read it as both and others reading as either/or.  Myself would use the commonality which has been performed by the industry for the last 50+ years and if there is a shelf life/expiration date, this would only be required.  If a shelf life or expiration date is used, the actual manufacturing date would not be necessary nor would it add any value to the labelling.  In fact, putting two dates on the sterile packaging might confuse the user.  If there is any clarification needed, a statement about the length of the shelf life could be made in the Instructions for Use (IFU) stating a "two year shelf life" which then a user could determine when the product was manufactured.  There may also be rare circumstances, based on risk of the device, where the shelf life and manufacture date would be included; this information should be included in the technical documentation as well as risk management describing why both would be needed.

Dear community,

My apologizes if the topic has already been discussed, but i could not found a clear response.

EU MDR GSPR 23.3 refers to information that shall appear on the "sterile packaging". 23.3 (h) refers to "month and year of manufacture" and 23.3 (i) refers to "use by date".

Q1) Is it mandatory to address both (manufacturing date AND use-by-date) on the sterile packaging?

or like on 23.2(j) Information on the label, we can use either "the date until when may be used safely" or "the date of manufacture". 

Thanks in advance for your comments

BR

ik

Dear community,

My apologizes if the topic has already been discussed, but i could not found a clear response.

EU MDR GSPR 23.3 refers to information that shall appear on the "sterile packaging". 23.3 (h) refers to "month and year of manufacture" and 23.3 (i) refers to "use by date".

Q1) Is it mandatory to address both (manufacturing date AND use-by-date) on the sterile packaging?

or like on 23.2(j) Information on the label, we can use either "the date until when may be used safely" or "the date of manufacture". 

Thanks in advance for your comments

BR

ik

Hi Iker,

I agree with Robert that in this case the MDR seems quite clear that both are mandatory (use of "shall", no "where applicable" and section (i) ends with "and").

Best regards, Christoph

Dear community,

My apologizes if the topic has already been discussed, but i could not found a clear response.

EU MDR GSPR 23.3 refers to information that shall appear on the "sterile packaging". 23.3 (h) refers to "month and year of manufacture" and 23.3 (i) refers to "use by date".

Q1) Is it mandatory to address both (manufacturing date AND use-by-date) on the sterile packaging?

or like on 23.2(j) Information on the label, we can use either "the date until when may be used safely" or "the date of manufacture". 

Thanks in advance for your comments

BR

ik

To further comment, yes it does say 'shall', but completely disagree with this approach since this is the only requirement in the world for this.  More and more every day liking FDA's "least burdensome approach" - adding regulatory hurdles and content which is not needed.

Hi Iker,

I agree with Robert that in this case the MDR seems quite clear that both are mandatory (use of "shall", no "where applicable" and section (i) ends with "and").

Best regards, Christoph

Dear community,

My apologizes if the topic has already been discussed, but i could not found a clear response.

EU MDR GSPR 23.3 refers to information that shall appear on the "sterile packaging". 23.3 (h) refers to "month and year of manufacture" and 23.3 (i) refers to "use by date".

Q1) Is it mandatory to address both (manufacturing date AND use-by-date) on the sterile packaging?

or like on 23.2(j) Information on the label, we can use either "the date until when may be used safely" or "the date of manufacture". 

Thanks in advance for your comments

BR

ik

Don't we all!!

Unfortunately, the regulators could care less about what we consider state of the art regarding these type of issues.

On the other hand, there is a symbol for manufacturing date, so it is feasible to add both.

To further comment, yes it does say 'shall', but completely disagree with this approach since this is the only requirement in the world for this.  More and more every day liking FDA's "least burdensome approach" - adding regulatory hurdles and content which is not needed.

Hi Iker,

I agree with Robert that in this case the MDR seems quite clear that both are mandatory (use of "shall", no "where applicable" and section (i) ends with "and").

Best regards, Christoph

Dear community,

My apologizes if the topic has already been discussed, but i could not found a clear response.

EU MDR GSPR 23.3 refers to information that shall appear on the "sterile packaging". 23.3 (h) refers to "month and year of manufacture" and 23.3 (i) refers to "use by date".

Q1) Is it mandatory to address both (manufacturing date AND use-by-date) on the sterile packaging?

or like on 23.2(j) Information on the label, we can use either "the date until when may be used safely" or "the date of manufacture". 

Thanks in advance for your comments

BR

ik