In terms of the FDA, the date format on labels is not part of UDI. However, the change in the regulation is in the UDI rule. The problem was that the date format without the day was ambiguous. For example, an expiration date "June 2020" could mean June 1, 2020 or June 30, 2020 or some other day in June.
Initially FDA proposed a different date format, but received many comments that it would not satisfy the ISO standard.
In one place the preamble says, "FDA received many comments (approximately 110) on the proposed date format and the proposed compliance date of the date format. Nearly all of these comments opposed the proposed date format, considered the time provided to implement this labeling change to be inadequate, or both. Although many comments recognized the benefits of standardized dates, most viewed FDA's proposal as too restrictive, too burdensome, inconsistent with the needs of international commerce, and inconsistent with existing industry practices. Comments noted that FDA's proposed date format would require different labels for a device when marketed in the United States and the same device when marketed in the European Union or other international markets. For example, comments noted that the date format required by the proposed rule "is not consistent with global requirements" and "perpetuates an opportunity for confusion" by not implementing "standardized international dating systems." "
In another place the preamble says, "One comment suggested that FDA should permit a manufacturer to use any date format it chooses, "as long as the manufacturer makes clear" what format it is using, and a similar comment suggested FDA should "should allow for multiple data formats" but should give "priority…to international standards." Several comments suggested that FDA should permit truncated dates, using only the year and month (YYYY-MM). This is one of the formats permitted under some international standards, such as International Organization for Standardization (ISO) 8601:2004, that were cited by comments." FDA disagreed with this comment.
In terms of the EU, this is an area in flux. There is EN 1041:2008 Information supplied by the manufacturer of medical devices. If I recall correctly it includes references to the date formats. However, ISO 20417 Medical devices – Information to be supplied by the manufacturer is planned for publication in June 2020. I anticipate that CEN will adopt it shortly thereafter.
In any case, I recommend using it to show compliance with the MDR Annex I.
------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------
Original Message:
Sent: 25-Jun-2020 09:35
From: James Bonds
Subject: Expiry Date Format for MDR
Hi,
I know that FDA defined an expiry date format of YYYY-MM-DD in the UDI Regulation (21 CFR 801.18). As an aside, I wish they would allow alternates of YYYY-MM and YY-MM, or at least apply enforcement discretion.
However my question concerns the MDR. After reviewing the MDR and the MDCG guidances on UDI, I can find no explicit description of the format for the expiration date with the exception of Annex I (GSPR) where it is stated an expiry date should be stated at least in terms of year and month [23.3(i)]. To add confusion, for date of manufacture [23.3(h)] the term month and year is used.
Is anyone aware of any definitive format required (or recommended) for EU expiry dates going forward?
Thanks,
James
------------------------------
James Bonds J.D.
Director Regulatory Affairs
Atlanta GA
United States
------------------------------