A minor linguistic discrepancy between the English version and the German version of the EU Medical Device Regulation (MDR) creates a point of contention.
In some sections of the German version of the MDR, the term “Neueste Stand” is used, whereas the term “State of the Art” is used in the English version.
While it might seem like a minor issue, this nuance carries serious practical, legal, and economic implications for medical device manufacturers and Notified Bodies.
The following table shows where differences can be found:
| MDR German Version | MDR English Version | ||
|---|---|---|---|
| Page / Section | Comment | Page / Section | Comment |
| 60 / Art 51 (3) (b) | “neuesten Wissenschaftlichen erkenntnissen” used | 60 / Art 51 (3) (b) | “New scientific evidence” used |
| 74 / Art 62 (4) (l) | “neuesten Erkenntnisstands” used | 74 / Art 62 (4) (l) | “state of the art” used |
| 113 / Art 106 (10) (d) | “neuesten Stand” used | 113 / Art 106 (10) (d) | “state of the art” used |
| 197 / Ann. IX (2.1) | “neuesten Stands der Technik” used | 197 / Ann. IX (2.1) | “state of the art” used |
| 219 / Ann. XIV (1) | “neuesten medizinischen Kenntnisstand” used | 219 / Ann. XIV (1) | “state of the art in medicine” used |
The core of the problem lies in how these concepts are different:
- The term “State of the Art” can be translated as “Stand der Technik”
Under established guidelines, such as MEDDEV 2.7/1 Rev. 4 and MDCG guidance MDCG 2021-5 Rev. 1, the “state of the art” does not mean the newest, absolute cutting-edge technology. Instead, it refers to what is currently accepted as standard practice in medical technology, and is considered safe, effective, and widely used. It is considered technology that is used as part of the standard of patient care.
- The term “Neueste Stand” can be translated as latest/newest technology or method of patient care. This represents cutting-edge, pioneering technology or care methods, or the newest devices that have just entered the market but are not yet widely used.
If taken literally, the term “Neueste Stand” implies that older, well-established and safe medical devices are suddenly non-compliant simply because newer technology exists. For example, a standard mechanical syringe is not the “Neueste Stand” compared to a smart, electronic injector, but it absolutely represents the “Stand der Technik” and standard of care. Thus, there could be bias in the way German notified bodies audit and review technical documents of German manufacturers compared to reviews and audits conducted by other notified bodies for manufacturers that in other countries.
If a German manufacturer relies on the German text of the MDR, they could face a higher, more expensive compliance barrier than a French, Italian, or Irish competitor reading “state of the art” (or its accurate equivalent), which permits the use of proven, legacy technologies. It creates an uneven playing field in market access. The German manufacturer is forced to present additional justifications, if they must defend themselves against a literal interpretation of an incorrectly translated text.
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