My company built the date of manufacture into the lot number. The IFU then described how to derive the date of manufacture from the lot number. Our NB did not raise any questions on this approach.
------------------------------
Stacey Backlund
Director, Regulatory Affairs
Chalfont PA
United States
------------------------------
Original Message:
Sent: 08-Aug-2022 10:01
From: Dan O'Leary
Subject: EU MDR Date of Manufacture (Sterile Medical Devices)
I responded to the original post and my answer does not change. However, I think I have a better explanation.
Article 23.2(j) is about the label, which is on the outer container, The requirement is "where there is no indication of the date until when it may be used safely, the date of manufacture".
Article 23.3(h) is about the sterile packaging. It has its own requirements that are not the same as the label. The sterile packaging requires both the date of manufacture and the "unambiguous indication of the time limit for using or implanting the device safely".
Notice that the label information does not have to appear on the sterile packaging.
The position of the NB is not clear from your post. If they require the date of manufacture on the label, then t4hey are wrong.
If they require the date of manufacture on the sterile packaging, then they are right.
Please let us know which position the NB is taking.
------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 05-Aug-2022 14:50
From: Anonymous Member
Subject: EU MDR Date of Manufacture (Sterile Medical Devices)
This message was posted by a user wishing to remain anonymous
Hello,
I wanted to discuss a topic that was posted several years ago now that we have a few years of EU MDR under our belt. Our notified body is stating that we need to include the date of manufacture, in addition to, the expiration date which is already included on our packaging. In previous discussions there was argument on the contradictions in this requirement between EU MDR Annex I 23.2 (j) and Annex I 23.3 (h). We also believe this will be cumbersome due to spacing constraints on our existing labels. Has anyone had any success in getting around this requirement? We argued the issue with spacing constraints, the fact that date of manufacture is easily known based on the expiration (24 months from date of manufacture), etc.. But have not been successful to date. We were going to discuss the contradiction in an final effort, but wanted to get feedback on others' experiences. Below is a link to the previous discussion.
https://connect.raps.org/communities/community-home/digestviewer/viewthread?GroupId=97&MessageKey=5856d9a5-16a4-4570-bf92-5b917d190799&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer