Regulatory Open Forum

Hello All,

For EU MDR, is the date of manufacture required to be present on the sterile packaging if the date of expiration is present on the sterile packaging?

EU MDR Annex I 23.2 (j) states the date of manufacture is only needed if there is no date of expiration. However, Annex I 23.3 (h) states the month and year of manufacture without the exception for the presence of the date of expiration. 

Can the exception in 23.2 (j) be applied to the sterile packaging? 

Annex I 23.2 Information on the label
The label shall bear all of the following particulars:
(i) an unambiguous indication of the time limit for using or implanting the device safely, expressed at least in terms of year and month, where this is relevant;
(j): where there is no indication of the date until when it may be used safely, the date of manufacture. This date of manufacture may be included as part of the lot number or serial number, provided the date is clearly identifiable.

Annex I 23.3 Information on the packaging which maintains the sterile condition of the device ('sterile packaging')
The following particulars shall appear on the sterile packaging:
(h) the month and year of manufacture,
(i) an unambiguous indication of the time limit for using or implanting the device safely expressed at least in terms of year and month

Thank you in advance,

------------------------------
Stacey B
United States
------------------------------

Can the exception in 23.2 (j) be applied to the sterile packaging?
No. Ann. I(23.3)(h) is clear that the sterile packaging has both the date of manufacture and the expiration date.

I don't know why the MDR authors created his inconsistency, but I'm sure there is a logical reason.

For the label, I think the issue is the UDI. This says that the one or other of two production identifiers is in the UDI – date of manufacture or expiration date.

The sterile packaging does not require a UDI.

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

Original Message:
Sent: 22-Jul-2020 08:21
From: Stacey Backlund
Subject: EU MDR Date of Manufacture on Sterile Package

Hello All,

For EU MDR, is the date of manufacture required to be present on the sterile packaging if the date of expiration is present on the sterile packaging?

EU MDR Annex I 23.2 (j) states the date of manufacture is only needed if there is no date of expiration. However, Annex I 23.3 (h) states the month and year of manufacture without the exception for the presence of the date of expiration.

Can the exception in 23.2 (j) be applied to the sterile packaging?

Annex I 23.2 Information on the label
The label shall bear all of the following particulars:
(i) an unambiguous indication of the time limit for using or implanting the device safely, expressed at least in terms of year and month, where this is relevant;
(j): where there is no indication of the date until when it may be used safely, the date of manufacture. This date of manufacture may be included as part of the lot number or serial number, provided the date is clearly identifiable.

Annex I 23.3 Information on the packaging which maintains the sterile condition of the device ('sterile packaging')
The following particulars shall appear on the sterile packaging:
(h) the month and year of manufacture,
(i) an unambiguous indication of the time limit for using or implanting the device safely expressed at least in terms of year and month

Thank you in advance,

------------------------------
Stacey B
United States
------------------------------

Hello Stacey,

If you purely read the regulation it does require date of manufacture to be on device label for "sterile" device according to Annex I, 23.3(h).  However, in practice and 30 years of dealing with medical device ... this is not a current GMP practice to have date of manufacture and shelf life/expiration date on the packaging.  I am not sure why they wrote the regulation in this manner because it is not consistent with any industry practice today.  While there may be some companies that do this, I personally have never seen it.  The Date of Manufacture is contained on equipment, instruments, capital equipment, or reusable equipment where there is no shelf life or expiration date.  Then conversely, sterile, consumable products have a shelf life date or an expiration date.  This is something I would argue the regulation was very poorly written to include a requirement which is not done in the wider industry.  I would also contend the date of manufacture is known as the shelf life date on the packaging is stated and the shelf life time period is included in the technical documentation.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 22-Jul-2020 10:30
From: Dan O'Leary
Subject: EU MDR Date of Manufacture on Sterile Package

Can the exception in 23.2 (j) be applied to the sterile packaging?
No. Ann. I(23.3)(h) is clear that the sterile packaging has both the date of manufacture and the expiration date.

I don't know why the MDR authors created his inconsistency, but I'm sure there is a logical reason.

For the label, I think the issue is the UDI. This says that the one or other of two production identifiers is in the UDI – date of manufacture or expiration date.

The sterile packaging does not require a UDI.

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

Original Message:
Sent: 22-Jul-2020 08:21
From: Stacey Backlund
Subject: EU MDR Date of Manufacture on Sterile Package

Hello All,

For EU MDR, is the date of manufacture required to be present on the sterile packaging if the date of expiration is present on the sterile packaging?

EU MDR Annex I 23.2 (j) states the date of manufacture is only needed if there is no date of expiration. However, Annex I 23.3 (h) states the month and year of manufacture without the exception for the presence of the date of expiration.

Can the exception in 23.2 (j) be applied to the sterile packaging?

Annex I 23.2 Information on the label
The label shall bear all of the following particulars:
(i) an unambiguous indication of the time limit for using or implanting the device safely, expressed at least in terms of year and month, where this is relevant;
(j): where there is no indication of the date until when it may be used safely, the date of manufacture. This date of manufacture may be included as part of the lot number or serial number, provided the date is clearly identifiable.

Annex I 23.3 Information on the packaging which maintains the sterile condition of the device ('sterile packaging')
The following particulars shall appear on the sterile packaging:
(h) the month and year of manufacture,
(i) an unambiguous indication of the time limit for using or implanting the device safely expressed at least in terms of year and month

Thank you in advance,

------------------------------
Stacey B
United States
------------------------------

Dan,

I think you give the authors of the MDR too much leeway.  I consider the inconsistency between Annex I 23.2(j) and 23.3(h) a bureaucratic snafu.  There are many other inconsistencies in the MDR because it is such a bloated and prescriptive regulation, and unlike FDA which can generally address inconsistencies with "enforcement discretion", the EU fails to have a uniform policy interpretive body.  The MDCG might get there someday, but not yet.

Regards,
James

------------------------------
James Bonds J.D.
Director Regulatory Affairs
Atlanta GA
United States
------------------------------

Original Message:
Sent: 22-Jul-2020 10:30
From: Dan O'Leary
Subject: EU MDR Date of Manufacture on Sterile Package

Can the exception in 23.2 (j) be applied to the sterile packaging?
No. Ann. I(23.3)(h) is clear that the sterile packaging has both the date of manufacture and the expiration date.

I don't know why the MDR authors created his inconsistency, but I'm sure there is a logical reason.

For the label, I think the issue is the UDI. This says that the one or other of two production identifiers is in the UDI – date of manufacture or expiration date.

The sterile packaging does not require a UDI.

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

Original Message:
Sent: 22-Jul-2020 08:21
From: Stacey Backlund
Subject: EU MDR Date of Manufacture on Sterile Package

Hello All,

For EU MDR, is the date of manufacture required to be present on the sterile packaging if the date of expiration is present on the sterile packaging?

EU MDR Annex I 23.2 (j) states the date of manufacture is only needed if there is no date of expiration. However, Annex I 23.3 (h) states the month and year of manufacture without the exception for the presence of the date of expiration.

Can the exception in 23.2 (j) be applied to the sterile packaging?

Annex I 23.2 Information on the label
The label shall bear all of the following particulars:
(i) an unambiguous indication of the time limit for using or implanting the device safely, expressed at least in terms of year and month, where this is relevant;
(j): where there is no indication of the date until when it may be used safely, the date of manufacture. This date of manufacture may be included as part of the lot number or serial number, provided the date is clearly identifiable.

Annex I 23.3 Information on the packaging which maintains the sterile condition of the device ('sterile packaging')
The following particulars shall appear on the sterile packaging:
(h) the month and year of manufacture,
(i) an unambiguous indication of the time limit for using or implanting the device safely expressed at least in terms of year and month

Thank you in advance,

------------------------------
Stacey B
United States
------------------------------