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[MED] Wheel marking followed by the year
Name Ban Kyung-don
File -
Hit 10 Date 2020.09.14
MarED Approved Recommendation Doc-ID: 16-627r3 AR GEN-048 040917.docx

Question raised:
For the marking of the year in which the wheel mark is affixed, can this be either the full 4 digits of the year or
the last 2 digits of the year?

Text/Explanations:
In Directive 2014/90/EU, Chapter 2, Article 10, Clause 3: “The wheel mark shall be followed by the
identification number of the notified body, where that body is involved in the production control phase, and by the year in which the mark is affixed.” The key difference in the text here in comparison to the old directive (96/98/EC) is that this stated “and by the last two digits of the number of the year”. Some Notified Bodies are now interpreting this as the marking must now be the full 4 digits of the year and that the last 2 digits only is no longer acceptable. Either should be allowed, because it seems there isn’t any logical or practical reason not to allow this as the only time possible confusion could arise is if an item were to be on the market for 100 years or more, which is highly unlikely. Furthermore, the “2-digit system” has been custom and practice for a long time and is fully recognised by all stakeholders dealing with MED equipment.
If this system of marking is not allowed any more, then this will cause considerable extra cost burden and inconvenience to manufacturers who will have to change systems, labelling, heat transfers, print screens, information manuals, declarations of conformity, technical files, moulding, tools and in some cases engraved plates. We do not find it a reasonable expectation that Industry should have to undergo these changes and costs without any perceived real necessity or benefit?
Furthermore, for smaller equipment such as lifejacket lights, HRU’s etc., the limited space available for marking the equipment means clarity and legibility of the numbering is lost if 4 digits are needed to be marked as opposed to 2 digits. It may also cause confusion in the market when the users of this equipment are used to seeing the 2 digits. There should be sensible continuity of the existing marking format.

Recommendation :
The marking of the year in which the wheel mark is affixed is acceptable in either 2-digit or 4-digit format, according to the manufacturers’ preference and existing practice.