EILMELDUNG – Authorities act on micro-power manufacturers
This post is also available in: Deutsch (German)
EILMELDUNG – Authorities trade microcurrent manufacturers
We have already reported in the past on the effort that reputable manufacturers of micro-power devices have to make in order for the devices to be properly CE marked and sold (placed on the market).
But we also reported on those who did not take it very seriously. In part, we were even exposed to ‘animosity’ as a result of such reports, but in view of patient and user protection, we saw this as a necessary evil. Not least from the perspective that microcurrent therapy is generally discredited as a result. This would not help anyone and would do ubitime damage to those who produce and market equipment to the best of their knowledge and belief.
For reasons of source or informant protection (Section 53 (1) No. 5 StPO), we will not deposit the following statements with sources and will make the manufacturers or device names unrecognizable by synonyms.
The ZLG (Centre of The Countries for the Protection of Health in Medicinal Products and Medical Devices) has investigated a report involving micro-current devices, which are classified under at least one. three different brand names of three different marketers were placed on the market. The problem is that only one of the devices was carried out by one of the manufacturers to carry out a correct conformity assessment procedure. Nor is it clear whether this was carried out on all equipment in accordance with Annex IV to RL 93/42/EEC.
Appendix IV stipulates that each individual device must be inspected by a notified body (DEKRA, TÜV, etc.). This was obviously not the case for the other two manufacturers, which appeared to have placed the same equipment on the market in a different form. For this reason, at least according to our knowledge, such equipment has already been confiscated by the authorities in the case of a user (physiotherapy).
The ZLG has already contacted several state authorities to check to which customers such devices have been sold. It can therefore be concluded that the process around these three devices/manufacturers has only just started.
This case gives an idea of what will happen on the market, because some have probably come up with the idea of selling the devices no longer as medical devices, but as wellness products. But manufacturers/sellers are often on the wrong side, because then the devices may no longer be used in any medical context, otherwise they will automatically become medical devices again. Whether you like it or not. Just a call in the instructions for use, flyers, internet pages, would suffice for this. It should also be noted that many users of such devices are active on social media. Even such information on medical applications of wellness products can lead to considerable problems, among other things.
What can you do as a user?
As a user, check the declaration of conformity of your microcurrent device. Check your manufacturer’s website for company certification. Just call your manufacturer and ask in what form the conformity assessment drive was carried out and have the ‘certificate’ (declaration of conformity) sent to you and also the certificate of certification. Reputable manufacturers do not make any secret of this and publish these documents on the website.
In case of doubt, ask the designated body of the manufacturer (they must and will gladly provide you with information!!). The named digit can be recognized from the four-digit number behind the CE mark on the type plate. Enter this number with the two letters ‘CE’ on Google, then you should find it quickly. Examples:
CE0123 = TÜV South
CE0044 = TÜV Nord
CE0482 = Medcert
CE0197 = TÜV Rheinland