Medical devices are products with a medical purpose that are intended by the manufacturer for use on humans.
This means that all devices used to treat illness, injury or disability in humans must be labeled accordingly in accordance with Section 9 of the German Medical Devices Act (MPG).
Medical Devices Directive (MDD)
ยง 9 CE-marking
(1)The CE marking shall be affixed to active implantable medical devices in accordance with Annex 9 to Directive 90/385/EEC, to in vitro diagnostic medical devices in accordance with Annex X to Directive 98/79/EC and to the other medical devices in accordance with Annex XII to Directive 93/42/EEC. 2Signs or inscriptions which are likely to mislead third parties as to the meaning or the graphic design of the CE marking must not be affixed. 3Any other marks may be affixed to the medical device, the packaging or the instructions for use of the medical device, provided that they do not impair the visibility, legibility and meaning of the CE marking.
(2) The CE marking shall be affixed by the person designated for this purpose in the regulations governing the conformity assessment procedures pursuant to the statutory order under Section 37 (1).
(3) The CE marking according to paragraph 1 sentence 1 must be affixed visibly, legibly and indelibly to the medical device and, if available, to the commercial packaging as well as to the instructions for use. 2The CE marking need not be affixed to the medical device if it is too small, its nature does not permit it or it is not appropriate. 3The CE marking must be accompanied by the identification number of the notified body that was involved in carrying out the conformity assessment procedure in accordance with Annexes 2, 4 and 5 of Directive 90/385/EEC, Annexes II, IV, V and VI of Directive 93/42/EEC and Annexes III, IV, VI and VII of Directive 98/79/EC, which led to the authorization to affix the CE marking. 4In the case of medical devices which must bear a CE marking and which are placed on the market in a sterile condition, the CE marking must be affixed to the sterile packaging and, where appropriate, to the commercial packaging. 5If a conformity assessment procedure is prescribed for a medical device, which does not have to be carried out by a Notified Body, no identification number of a Notified Body may be added to the CE marking.
