Hello Anon,
It depends on the device, as generally the Day, Month, and Year would be included so a user knows the time span from date of manufacture precisely. Though in my experience, if the devices or products are more durable, reusable, long-lasting product like equipment or reusable instruments, then the Month and Year is often acceptable. While it is not applicable to the European Union, there are other regulatory agencies which accept Month and Year for durable products.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 01-May-2024 15:07
From: Kevin Randall
Subject: Europe MDR, Date of Manufacturer
As a general rule, yes. For example, EN ISO 20417:2021 (as amended) is an Annex I.1 and 1.4 generally acknowledged state of the art requiring that the manufacturing date for such scenarios shall include the year, month, and day of manufacture.
That said, depending on the risk level and on the maturity and effectiveness of the risk management system and documentation, it may be permissible for the manufacturer to write a justification for deviation if a high level of protection of health and safety is maintained without adversely affecting the benefit-risk ratio.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 01-May-2024 09:09
From: Anonymous Member
Subject: Europe MDR, Date of Manufacturer
This message was posted by a user wishing to remain anonymous
MDR Annex I, 23.2. Information on the label
The label shall bear all of the following particulars
(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;
Does the date of manufacturer need to include the Day and Month