Nepper, Tug, Farmer Catcher – Microcurrent
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Nepper, Tug, Farmer catcher – Microcurrent?
Not again! We have reported in detail in the Past on the CE labelling Of Microcurrent Devices and, in our View, have made it abundantly clear that false Information on CE labelling is not a Cavalier offence. But some may never get smart.
A new Player in the Market? At the very least, a relatively new Manufacturer of Microcurrent Devices is trying to roll up that Field in Germany and Europe. In particular, the Frequency-specific microcurrent therapy is being approved. The Manufacturer from Germany goes very far and praises the Effect of his Devices in the following Areas:
- • “Depression,
- • Neurom,
- • Adrenal Cortex,
- • Thyroid Gland,
- • Brain,
- • Spinal cord,
- • Mensturatory Complaints,
- • Ovarian Cyst,
- • Uterine Myom,
- • […]”
In Addition, there is also cosmetic and Wellness Treatment.
How can that be?
The Regulation on Medical Devices 2017/745 is just around the Corner and almost every notified Body in Germany insists on MEDDEV 2.7/1 rev. 4. The German Authorities also want to see a clinical Evaluation in accordance with MEDDEV standards. This means that every Indication and Statement on the Effect and the respective Application area of the Microcurrent Device must be PROVEN and this IS BEFORE OF THE FIRST INVERY proven by a Notified Body. This is at least from the IIa risk Class, which the Manufacturer himself presents on its Website, albeit wrongly as a Certificate.
How then, are an official Indication of the above Indications or Areas of application possible? Either the Manufacturer is familiar with the Medical Device law and the regulatory Requirements for Medical Devices and Microcurrent Devices or He has no Idea or he just lets it come down to it.
Now which of the Variants is true, we cannot say at this Point, but what we can say is that the Statements on a CE-MARKING AND about a “MEDICAL CERTIFICATE IIA” suggest that a Lack of Know-how is probably the Problem here. Represents. This can create a not too small danger for patients and, Through such statements, An entire industry suffers.
Microcurrent Devices are Medical Devices of the IIa Risk-class
“Pursuant to Section 19 (19). 1 Sentence 1 MPG is the EIAs a matter of Principle, a clinical Evaluation based on clinical data under section 3 (25) MPG to prove the content of medical Devices for the intended purpose. According to Section 3 (25), second sentence, MPG, clinical Data may also come from the clinical Trial of the medical Device in question or similar Medicine.“(Gassner 2018, P. 40).
“Medical Devices may only be operated and applied in accordance with their Purpose and in accordance with the Provisions of this Regulation and in accordance with the generally accepted Rules of Technology” (MPBetreibV 2002, § 4, Paragraph 4).
However, the Purpose chosen By the Manufacturer describes the Purpose of the Microcurrent Device, but all statements and thus also AND especially WERBEAUSSAGEN ON Websites, Flyers and lectures.
Thus, this Manufacturer has interpreted its Purpose very broadly and must have carried out Evidence or a compliance assessment For its products. Otherwise, the Microcurrent Device would not be properly CE-labelled!!!
What is meant by the risk Class, which a Manufacturer mistakenly Represents as a “Medical Certificate.”
In principle, Microcurrent Devices must be evaluated according to the ‘ Basic Requirements ‘ and meet them (RL 93/42/EEC, Article 3). Among Other Things, a Classification of the Microcurrent Device must be made into one of four Risk classes. I, IIa, IIb or III. However, by Classifying it alone, a Microcurrent Device is far from a correctly labelled Medical Device.
For Microcurrent Devices, Rule 9 of Directive 93/42/EEC is used: “All active therapeutic Products intended for The Delivery or Exchange of Energy belong to class IIa, unless the Release or Exchange of Energy to the human Body may take Into account the Type, density and exchange of energy. Body Parts where the Energy is applied pose a potential Hazard due to the Characteristics of the Product; In this Case, they are assigned to Class IIb“(RL 93/42/EWG, Anh. IX, Paragraph 3.1).
Microcurrent devices are medical devices within the meaning Of The guideline, the regulation On medical devices to be Applied next year and Under The Medical Devices Act. Since they fall into the IIa risk class according to their risk, the manufacturer must include a notified body In the conformity assessment process.
This can be seen for Users (Doctors and Therapists) in the fact that a four-digit number must be listed behind the CE mark . If You search Google for this Number with the word: “notified body,” Then you will find the name of the designated Location in a Database.
By the Way, manufacturers who show transparency specify it directly on their Website.
A Risk class has absolutely nothing to do with a MEDICAL CERTIFICATE and to present it to laymen, as a ‘ quality predicate ‘ is also quite reprehensible, since only a few In the thicket of Norms, Guidelines and regulations Actually know what’s known.
However, a Manufacturer that puts a Microcurrent Device on the Market in Germany should know this!
Once again it can be seen how complex (not to be confused with complicated!) the correct Compliance assessment of Microcurrent Devices is and what Expertise is needed for this. Once quickly designing a Product and throwing it onto the Market, it’s simply not possible.
Even for experienced Engineers and Developers, it is often not possible to deal with all regulatory Requirements and keep their Knowledge of them up-to-date.
On 25 May 2020, the European Union’s ‘ Medical Devices Regulation 2017/745 ‘ comes into force and is to be met and applied by manufacturers from the Date on Date. This will replace Directive 93/42/EEC, which has already been quoted several times, from 1993. The Regulation is far more comprehensive than the Guideline, and this presents many, if not all, manufacturers with very large Hurdles.
Under Article 15 MDR, each Manufacturer must have a ‘ responsible Person ‘ or name it from 25 May 2020. This person responsible, also referred to as ‘ Qualified Person ‘, is responsible for Complying with the Regulatory Requirements. This Person must perform the following Activities:
- – check and maintain the Conformity of Microcurrent Devices,
- – keep technical Documentation up to date,
- – ensure Market Surveillance by Market (PMS – Post-Market-Surveillance),
- – carry out Incident messages.
(Backhaus et al. 2017, P. 17)
Yet this person in charge cannot be anyone. In addition to the high Level of responsibility, MDR also places strict requirements on the Qualification of such a responsible Person:
“(a) Diploma, certificate or Other proof of Formal qualification By completing a University degree or a Training course recognised by the Member State concerned as equivalent In law, medicine, Pharmacy, engineering or any Other relevant scientific Disciplines and at least one Year of Professional experience in Medical Devices;
Regulatory Issues or Quality Management Systems related to
(b) Four years Of professional experience In Regulatory matters Or Quality management systems related To Medical devices“(MDR 2017, Article 15 (1), lit. a + b).
For Manufacturers who Think that risk Classification is a “MEDICAL CERTIFICATE,” it will be very difficult in the very near Future!
Backhouse, C.; Benad, H.-J.; Pleiss, Th. (2017): The new Regulation (EU) No. 2017/745 on Medical Devices. What changes for Medical Device manufacturers and Operators. In: mt | Medical Technology (4), p. 16 – 21.
Gassner, Ulricht M. (2018): Certification-centric and non-certification centered clinical Trials (Part 1). In: MPR journal for the Entire Medical device Law 18 (2), p. 37 – 72.
MDR (2017): Regulation (EU) 2017/745 of The European Parliament and the Council of 5 April 2017 on Medical Devices, amending Directive 20023/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and Repealing the Directives 90/385/EEC and 93 /43/EEC of the Council.
MPOperating V (2002): Regulation on the Erection, Operation and Use of Medical Devices (Medical Devices Association – MPOperating V) *. Erwin Deutsch, Hans-Dieter Lippert, Rudolf Ratzel, Brigitte Tag and Ulrich M. Gassner (Ed.): Commentary on the Medical Devices Act (MPG). Berlin, Heidelberg: Springer Berlin Heidelberg.
RL 93/42/EWG: RIGHTLINIE 93/42/EWG OF THE RATES from 14 June 1993 on Medical Devices. Modified by Directive 2007/47/EG of the European Parliament and the Council of 5 September 2007 L 247, Page 21 OJ. L 169 of 12.7.1993, Page 1: European Union.