Dental Treatment Unit (aka Dentist's Chair) requirements

N

nieuwlaat

#1
Hello,

Since this is my first post here I will introduce myself briefly.
I am working for a company that has been marketing dental equipment in the Netherlands for almost 20 years. I have been working for this company for almost a year now. I am a lawyer by training, but I have no specific knowledge of application of standards, methods etc. relating to medical devices.

At the moment we are working on the development of a new product line. At first we will be exclusively marketing the new product to the European market. (mainly BeNeLux, Nordic countries and Germany).
The product is a Dental Treatment Unit, sometimes referred to a dentist's chair (although the actual chair in which the patient sits is not included in our product!)

My first priority is to work out what are the technical and procedural requirements that apply to our product category, to which we have to comply to be able to put the product on the market in the first place. Also, a reasonable level of protection from claims is desirable.

The main problem that I have is that it is not clear to me where I can find an overview of the requirements we have to fulfil. The information I have found so far has been detailed enough, but I have no idea what is actually important to me and what isn't.

I have worked out that the product can probably be classified as a Medical Device, Class I according to the European Medical Devices Directive (93/42/EEG:2007)
It seems that the procedure to be able to put the CE mark on it is pretty straightforward and does not require auditing, etc. But perhaps there is more to it.

What steps should I take next? Am I missing important stuff that might interfere with market introduction?

If you need more info, examples or anything, please let me know.

Thanks In Advance! :agree1:
 
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Wes Bucey

Quite Involved in Discussions
#2
Re: Dentist's Chair - help needed to get oversight on requirements

Hello,

Since this is my first post here I will introduce myself briefly.
I am working for a company that has been marketing dental equipment in the Netherlands for almost 20 years. I have been working for this company for almost a year now. I am a lawyer by training, but I have no specific knowledge of application of standards, methods etc. relating to medical devices.

At the moment we are working on the development of a new product line. At first we will be exclusively marketing the new product to the European market. (mainly BeNeLux, Nordic countries and Germany).
The product is a Dental Treatment Unit, sometimes referred to a dentist's chair (although the actual chair in which the patient sits is not included in our product!)

My first priority is to work out what are the technical and procedural requirements that apply to our product category, to which we have to comply to be able to put the product on the market in the first place. Also, a reasonable level of protection from claims is desirable.

The main problem that I have is that it is not clear to me where I can find an overview of the requirements we have to fulfil. The information I have found so far has been detailed enough, but I have no idea what is actually important to me and what isn't.

I have worked out that the product can probably be classified as a Medical Device, Class I according to the European Medical Devices Directive (93/42/EEG:2007)
It seems that the procedure to be able to put the CE mark on it is pretty straightforward and does not require auditing, etc. But perhaps there is more to it.

What steps should I take next? Am I missing important stuff that might interfere with market introduction?

If you need more info, examples or anything, please let me know.

Thanks In Advance! :agree1:
Is your company registered to ISO 13485? If so, the registrar who has issued your certificate is one resource you can mine. At the very least, if it doesn't supply the oversight itself, it can steer you to a competent, authoritative source.
 
N

nieuwlaat

#3
Re: Dentist's Chair - help needed to get oversight on requirements

Is your company registered to ISO 13485? If so, the registrar who has issued your certificate is one resource you can mine. At the very least, if it doesn't supply the oversight itself, it can steer you to a competent, authoritative source.
Thanks for the quick response!

As far as I know the company is not registered to ISO 13485, likely never has been. Is this a must-have (as in: legal obligation) or simply a more or less convenient way to tackle the issue?

Best regards
 

Wes Bucey

Quite Involved in Discussions
#4
Re: Dentist's Chair - help needed to get oversight on requirements

Thanks for the quick response!

As far as I know the company is not registered to ISO 13485, likely never has been. Is this a must-have (as in: legal obligation) or simply a more or less convenient way to tackle the issue?

Best regards
The first question becomes, "Is this truly a medical device according to the legal definition of the governmental jurisdiction where it will be sold?" If yes, many European countries require registration and thus oversight of the product. Many of those same jurisdictions subscribe to a "harmonization" pact whereby registration to ISO 13485 by an approved registrar can save the trouble and expense of individual registration in each country. It's a legal question, not really a quality one.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Hello,

Since this is my first post here I will introduce myself briefly.
I am working for a company that has been marketing dental equipment in the Netherlands for almost 20 years. I have been working for this company for almost a year now. I am a lawyer by training, but I have no specific knowledge of application of standards, methods etc. relating to medical devices.

At the moment we are working on the development of a new product line. At first we will be exclusively marketing the new product to the European market. (mainly BeNeLux, Nordic countries and Germany).
The product is a Dental Treatment Unit, sometimes referred to a dentist's chair (although the actual chair in which the patient sits is not included in our product!)

My first priority is to work out what are the technical and procedural requirements that apply to our product category, to which we have to comply to be able to put the product on the market in the first place. Also, a reasonable level of protection from claims is desirable.

The main problem that I have is that it is not clear to me where I can find an overview of the requirements we have to fulfil. The information I have found so far has been detailed enough, but I have no idea what is actually important to me and what isn't.

I have worked out that the product can probably be classified as a Medical Device, Class I according to the European Medical Devices Directive (93/42/EEG:2007)
It seems that the procedure to be able to put the CE mark on it is pretty straightforward and does not require auditing, etc. But perhaps there is more to it.

What steps should I take next? Am I missing important stuff that might interfere with market introduction?

If you need more info, examples or anything, please let me know.

Thanks In Advance! :agree1:
Hi,

The Medical Devices Directive is your best friend. Basically, everything you need to know is there. When in doubt, consult the rich guidance available on line; best start with the MEDDEV official guidance (then you could move on - if need be - to NB-MED, GHTF etc.).

If indeed the device at question is a class I device (with no measuring function), then the process is pretty much straightforward as you've depicted and very little guidance would be required. Read the entire MDD text, then focus on annex I and annex VII.

All the best,
Ronen.
 

pkost

Trusted Information Resource
#6
You have said that you intend to market in the EU, and are therefore required to follow the Medical device directive (93/42/eec). This document tells you all you need to know and what you need to do to market in the EU.

A quick run through for you:

Under this directive a medical device is defined as

‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of
disease,
— diagnosis, monitoring, treatment, alleviation of or compensation
for an injury or handicap,
— investigation, replacement or modification of the anatomy or of
a physiological process,
— control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means; (b) ‘accessory’ means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device;
Your dentist chair falls under this definition (an accessory is to be treated as a device).

The next step is to identify the classification, you can do this in Annex IX of the directive. I would check for yourself, but I would imagine a dentist chair falls under rule 1 (non invasive) or 12 (active device) which makes it a class 1 device.

Assuming that you agree it is class 1, Article 11 tells you how you should go about conforming with the requirements.... specifically:
article 11 para 5 said:
In the case of devices falling within Class I, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, follow the procedure referred to in Annex VII and draw up the EC declaration of conformity required before placing the device on the market.
Article VII is probably too long to copy out here, but to summarise you have to
1.put together a technical file (detailed in para 3); this includes demonstrating that you comply with all the essential requirements in annex I.
2. Put in place procedures to handle vigilance, including the requirements of Annex X - clinical evaluation and complaint reporting
3. Write a declaration of conformity.

There is no specific requirement to have a quality management system in place, although if you do, ISO 13485 is the way to go. I would certainly refer to this document when it comes to writing your vigilance procedures and for document retention.

I would also recommend that you look through ISO 14971 which relates to risk management for medical devices; again there is no requirement for this.

When demonstrating compliance with the essential requirements, it is best to use harmonised standards (you can find a list here.. http://ec.europa.eu/enterprise/poli...-legislation/list-references/medical-devices/) as these lead to assumed compliance (both 13485 and 14971 are harmonised), failing that, national standards or guidance is good. Failing that clinical evaluation (annex X) and risk assessment.




Another small point which may be missed...
Under article 14, when you have all of this in place, but before you market, it is necessary to register with your competent authority to inform them that you are placing a class I medical device on the market - you only need to do this for your CA, not all the countries you are selling into.

Final note - these regulations apply to EU countries only, other regulations apply territories outside the EU

[edit] realised dentist chairs tend to be powered to provide light and or move patients up/down/left/right/tilt etc. therefore are active devices and not covered under rule 1 - rule 12 applies in this case.
 
Last edited:
N

nieuwlaat

#8
Hi there!

just wanted to thank all contributors to this thread, your comments have been helpful. :tg:

best regards,

w. nieuwlaat
 
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