LuXXaMed Microcurrent Devices – Medical Devices
The microcurrent devices manufactured by LuXXaMed GmbH are medical devices
The microcurrent devices manufactured by LuXXaMed GmbH are medical devices within the meaning of the EU Medical Devices Regulation 2017/745 and therefore comply with the essential safety and performance requirements. Furthermore, LuXXaMed GmbH meets the regulatory requirements of DIN EN ISO 13485 (quality management system for medical device manufacturers) and is certified by TÜV Nord Cert.
When is a microcurrent device considered a medical device?
‘an instrument, apparatus, device, software, implant, reagent, material or other article which, according to the manufacturer, is intended for human use and, either alone or in combination, is intended to fulfil one or more of the following specific medical purposes:
— diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of diseases,
— diagnosis, monitoring, treatment, alleviation or compensation for injuries or disabilities,
— investigation, replacement or modification of the anatomy or of a physiological or pathological process or condition,
— the provision of information through the in vitro examination of samples derived from the human body — including organ, blood and tissue donations”
(EU MDR 2017/745, Art. 2, para. 1)
It follows that a microcurrent device used as part of a therapeutic and/or medical intervention (therapy/treatment) is automatically a medical device and may only be used by the therapist/doctor in this context if the microcurrent device/medical device is correctly CE-marked (colloquially referred to as having been authorised as a medical device).
What are active medical devices?
‘Active medical devices’ refer to medical devices or technologies that require energy to function. This energy may come from an external source, e.g. mains electricity, batteries or even energy generated by the human body (e.g. muscle movement). The energy is used to enable specific functions of the medical device.
Examples of active medical devices include:
- Pacemakers: These devices use electrical impulses to regulate the heart’s rhythm.
- Insulin pumps: These continuously supply the patient’s body with insulin.
- Electric hospital beds: These beds can be adjusted electrically in terms of position and height to improve the patient’s comfort and facilitate their care.
Medical imaging systems: These include devices such as ultrasound scanners, MRI scanners and CT scanners, which use electrical energy to produce images of the inside of the human body. - Hearing aids: These small devices use batteries or rechargeable batteries to improve hearing in people with hearing loss.
- Microcurrent devices: Microcurrent devices are powered by the mains and/or a rechargeable battery to transmit electrical signals (microcurrents) at specific frequencies to the patient.
Active medical devices can be used for both diagnostic and therapeutic purposes and are invaluable in many areas of medicine. They are subject to specific regulations and standards to ensure their safety and effectiveness.
Podcast on the topic: Active medical devices
Where can users find information on correct labelling?
As a user of medical technology (doctor/therapist), you have several options for finding out about the correct ‘authorisation’ of your product. In the case of a microcurrent device, you will find an initial indication on the device’s type plate. Microcurrent devices are Class IIa medical devices (under both the old legislation Directive 93/42/EEC and the current EU MDR 2017/745) and therefore a notified body (TÜV, DEKRA) must be involved in the product assessment process. Consequently, a 4-digit number MUST appear after the CE mark, which allows you to see which notified body is involved. The ZLG (Central Office of the Federal States for Health) has published a list here LINK.
You can submit an enquiry regarding your medical device to any notified body and receive a reply! Most notified bodies even have an online form that allows you to search by manufacturer and/or certificate. You can find an example here at TÜV Nord: Certificate search
