Test your knowledge about CE certification

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QS certificate HNQS certificate HN 2be honest to yourself and try to answer the following questions first below you will find the answers

1. Who assigns a regular CE certificate to a device ?

A) local government agency

B) manufacturer

C) Certifying agency usually called notified body


2. What means a 4 digit number behind the CE sign e.g. CE 1275

A) It determines what kind of CE certification was done

B) It allows to determine the agency that assigned the certificate

C) CE signs without this number are not medically CE certified


3.If I use a device that has a medical CE sign this allows me

A) To do medical evaluation or therapy even if I am not a medical professional

B) It gives me the right to charge my services to insurance companies even if my credentials do not cover this kind of modality

C) It gives me more credibility in the eyes of the public


4. If I own a biofeedback or bioresonance device that has a medical CE sign

A) I can use it legally for any kind of disease for which biofeedback or bioresonance is useful as long as I my medical qualification allows me to use these kind of techniques

B) It proves its medical effectiveness for biofeedback or bioresonance techniques

C) None of the above

 

5. Using a medically CE certified device provides

A) More freedom in how I use it

B) More freedom in how I advertise my services

C) Transfers some of the liability to the manufacturer

D) Protects me from fake clients that just want to sue me for mal-practice



 

"Declaration of conformity" like this one that we declared for our own product years ago can issue any manufacturer - in the end it does not mean much or protect you - so better understand what CE stands for in your device

"Declaration of conformity" like this one that we declared for our own product years ago can issue any manufacturer - in the end it does not mean much or protect you - so better understand what CE stands for in your device

 

1. Who assigns a regular CE certificate to a device ?

A) local government agency

B) manufacturer

C) Certifying agency usually called notified body


B) is correct

Most CE signs are put on devices by the manufacturer alone without ever any government or certifying agency involved. This is completely legal as it is just a way of the manufacturer to show that he observed one or another legal requirement. So it is very easy to put your own sticker on it – There are hundreds of different CE norms that can be covered by always the same CE sign, that does by itself not show what it stands for. This total nonsense buro-cracy allows many manufacturers to give the impression of safety of their product to a naïve public . For example the above CE sign that we had assigned our product years ago was completely legal as it was certifying that the system did not produce any significant electromagnetic emission – to make this CE sign cost nothing and is what many manufacturers do to fool their clients.

 

2. What means a 4 digit number behind the CE sign e.g. CE 1275

A) It determines what kind of CE certification was done

B) It allows to determine the agency that assigned the certificate

C) CE signs without this number are not medically CE certified


B) and C) are correct

Which means if you see a device without the 1-4 digit numb behind it you know it cannot be a medically certified device, it is just one of the many devices that fake a medical certification, the number allows you not to know for what medical function it was certified it is just the number of the certifying agency

 

3. If I use a device that has a medical CE sign this allows me

A) To do medical evaluation or therapy even if I am not a medical professional

B) It gives me the right to charge my services to insurance companies even if my credentials do not cover this kind of modality

C) It gives me more credibility in the eyes of the public


Only C) is correct

But be aware that using a medically certified device if you are not a medical professional or if your training and license does not cover this kind of device then you risk your license and your savings as there are many people out there that do not want to be healed but just make money on naïve practitioners

For that reason at Inergetix we do so much education in this direction and do not just try to sell our product with the glamor of CE signs but show you what risk they possibly pose for your practice and how much they in fact limit what you can do – we even offer our devices optionally with a wellness CE sign that does not put you under the limitation that come with a medically certified device and we teach you how you can present what you are doing by discriminating your work from physical, chemical or energetic medicine that are all so highly regulated

 

4. If I own a biofeedback or bioresonance device that has a medical CE sign

A) I can use it legally for any kind of disease for which biofeedback or bioresonance is useful as long as I my medical qualification allows me to use these kind of techniques

B) It proves its medical effectiveness for biofeedback or bioresonance techniques

C) None of the above


Only C) is correct

Medically devices are not certified for a specific modality but only for the use of specific diseases where they have proven effectiveness – so if someone wants to make some money on you he makes an appointment and then asks you while he records it “If you treat him with a medical device” and if you confirm and then treat him you are with one foot already in prison. Most devices particularly in the alternative field, if at all, have proven effectiveness only for ONE disease to get the CE sign as medical effectiveness studies are expensive and difficult for non-mainstream modalities. Most manufacturers make it a sales strategy to foster this naivety on part of their clients and give him the impression that a medical CE allows him now to use the device for any indication he finds appropriate. Almost always they do not make it clear for which disease it is legally usable as medical device.

At Inergetix we possibly have proven the widest field of effectiveness which are a) wound healing b) pain management and c) depression. As most disease have at least a component of wound, pain or depression this allows an unprecedented scope of legal use

 

5. Using a medically CE certified device provides

A) More freedom in how I use it

B) More freedom in how I advertise my services

C) Transfers some of the liability to the manufacturer

D) Protects me from fake clients that just want to sue me for mal-practice


None of the above

Using a medically certified device limits what you can legally do with it severely, you can only use it for the indications that it has proven effectiveness, you have to have the appropriate license and training for this kind of modality. The manufacturer only covers electrical mal-functioning and other less likely risk factors. Most of all it opens the door to all these people who just want to make a living on legal system that was created to protect people but has now become a means for lawyers and fake patients to abuse your wish to help and heal.

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Inergetix Founder Born on 1962 in Stuttgart/Germany, Founding of the Instrument Systems Corp Munich.

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