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Other | March 3, 2020

I recently received another interesting question that I want to share with you (with minor modifications for better understanding). It reads as follows: 

“We have a product that is supposed to be classified as a medical device. To our knowledge, these products are subject to specific laws and regulations. 

Is it true that even if there is a pictogram on the product and it is a medical device, it is not necessarily a dangerous chemical?“ 

Below is my answer: 

“Let's first look at what the regulations say (and later how we can interpret them in relation to your question).

The CLP Regulation, Article 1, states that this Regulation does not apply to “medical devices as defined in Directives 90/385/EEC and 93/42/EEC, which are invasive or used in direct physical contact with the human body, and in Directive 98/79/EC;” 

These Directives were replaced by Regulations 2017/745 and 2017/746. 

Regulation 2017/746 on in vitro diagnostic medical devices states: 

In the case of devices containing a substance or a mixture which may be considered as being dangerous, taking account of the nature and quantity of its constituents and the form under which they are present, relevant hazard pictograms and labelling requirements of Regulation (EC) No 1272/2008 shall apply. Where there is insufficient space to put all the information on the device itself or on its label, the relevant hazard pictograms shall be put on the label and the other information required by Regulation (EC) No 1272/2008 shall be given in the instructions for use.” 

Regulation 2017/745 on medical devices only states: 

“4. The CE marking shall be affixed before the device is placed on the market. It may be followed by a pictogram or any other mark indicating a special risk or use.” 

The pictogram is not more precisely defined. 

If your product is not an in vitro diagnostic medical device, only Regulation 2017/745 must be complied with. 

Given that the pictogram is not precisely defined, a CLP pictogram may also be used. The meaning of this pictogram should be written on the label. 

If a CLP pictogram is used on the label, it must be used in accordance with the CLP Regulation. 

However, the CLP pictogram is only assigned to dangerous chemicals. 

The product may be a dangerous chemical and a medical device at the same time, but in this case, only a more detailed regulation - which is the Regulation on medical devices - must be complied with.” 

If you identify yourself in these posts and need our help in interpreting chemical law, or simply don't have the time to meet these challenges, please let me know. We would be happy to help you.

 

 

Disclaimer:
Information on this blog is prepared with utmost care, but it is not about (chemical) consulting, and the provider does not assume any responsibility or liability for the correctness, accuracy and up-to-dateness of published content. If you need advice for a specific case, you can write to us at bojan.dimic@bens-consulting.com

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