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Shivangi Dubey
Regulatory Affairs
December 2018
EU MDR classification for Eye Mask
< 1 min reading time

I found the “The Eye Doctor Essential®” on Amazon.

What would be the device classification according to the new MDR? I believe it would be a Class IIa because it produces heat. Is this right?

Thanks you!

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Posted by Shivangi Dubey
Asked on December 26, 2018 7:27 pm
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Private answer
Gottfried Griesmayr

According to rule 9 it is at least Class IIa. Considering the substantial risk when putting a microwave heated device on the eye I believe Class IIb may be justified! This depends on risk assessment. How is the temperature controlled?
Class IIa is already applicable under MDD, rule 9 (active therapeutic device intended to administer or exchange energy)

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Shivangi Dubey

Thanks, Gottfried for your response.

There is no control over the temperature but suggested to keep for while inside the micro oven to absorb heat.
https://www.youtube.com/watch?v=gBgqZsdCYAw

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Gottfried Griesmayr

There is no indication of a CE-mark! Without CE-mark it must not be distributed in Europe via Amazon!

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Shivangi Dubey

Yes its not visible but this is CE marked. I have checked their website and got this claim- "All of The Body Doctor products are tested voluntarily to BS8433/2004 Personal Warmer test. CE certified. Our products have also passed: REACH BSEN 14362-1/2, Pesticides, EN71 Pt 3."

https://www.the-body-doctor.com/professional-resources/

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Gottfried Griesmayr

If it is CE-marked, there must be the CE symbol on the product (not smaller than 5 mm) together with the 4-digit registration number of their notified body, who issued their EC-certificate.

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mahamad shafi S S

i guess guideline says , this minimum dimension may be waived for small-scale devices.

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