Is CE valid in Switzerland for self certified products?

H

Harsh

Involved In Discussions
#1
#1
Hello Everyone,

Recently, we have received a list of questionnaires from a customer in which they have asked about whether our products are compliant to sell in Switzerland or not. We are not currently selling any products in Switzerland, but according to my previous research, the MRA was done and CE was acceptable in Switzerland. But I do not have any idea about the current situation.

Can anyone provide details about whether the EC Declaration is still valid in Switzerland for lab devices like centrifuges, stirrers, shakers, etc. or not?

If CE is still valid, then there is no issue. Our products are CE certified, but if not, what are the new Swiss requirements for compliance?

I want to confirm that none of our devices fall under the scope of MDR or IVDR. They are only being sold in Europe as general-purpose devices.

Thanks in Advance.
 
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A

Ann MD

Registered
#2
#2
As far as I am aware, CE marking is not mandatory in Switzerland but products bearing the CE mark are allowed on the Swiss market. CE marking is only required for goods exported from Switzerland to the EU (or EEA) which fall within the scope of EU directives.
 
H

Harsh

Involved In Discussions
#3
#3
Hello Ann,

Does that mean we can sell our CE-compliant devices in Switzerland without any additional testing?

Kindly suggest.
 
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