Archive for April, 2014

Body Scales Fitness Equipment

Without medical purpose no medical device: most dishes have seen it so far, and so an expensive and time-consuming certification as a medical product saves you the manufacturers of devices or substances for examination or modification of the anatomical structure or a physiological process, if these products were not explicitly medical purposes. This could change now by a recent decision of the Federal Supreme Court (BGH).The medical product definition captures also such items and substances which serve the investigation, replacement or change of the anatomical structure or of a physiological process, without pharmacologically. Such influencing of the anatomical structure or physiological processes is not only classic”medical devices as about implants possible. Rather, the question that even fitness or other training devices, devices that identify biometric data with face detection in personal interlock systems and evaluate, or even banal body scales are captured arises. The same applies to certain wellness or cosmetic devices. However, the previous case law tended to read the unwritten feature of a medical purpose in the definition of medical devices.

Only then, if so state the investigation or modification of the anatomical structure or a physiological process for medical purposes in speech, a medical device subject to certification should be accordingly. Otherwise, it required no expensive and lengthy conformity of such equipment. Which is now the Supreme Court (decision of the 07.04.2011, I ZR 53/09) opposed. According to the BGH, targeting a medical purpose is rather just no unwritten construed of the medicine product concept. The European Court of Justice (ECJ), the Supreme Court has submitted this question to the decision, however, has the last word. While he is BGH to recognise that he nevertheless does not necessarily want to, fitness and other training equipment or body scales the medical product law.

On what criteria such devices but then can be separated from the medicine product concept, suggests the Supreme Court only on, without to deliver final criteria. Just for the operators of innovative borderline products in the fitness, wellness and beauty area, which previously were allowed to imagine themselves due to lack of medical purpose outside of the medical product law, it could be so closely, if the Court follows the opinion of the BGH. Even though until then, it will take some time, also some Court of first instance in the case of competition disputes could now Invert on the line of the BGH and take the marketability of units without proper marking. The market for health products threatens to once again close. Other non-binding and free information related to the medical product law, see

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Monday, April 21st, 2014 News Comments Off on Body Scales Fitness Equipment