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FAQ’s - CE Certification for Class I devices

Q1. One of our Customers in Europe is asking for a both CE Certification and MDD Certification for the Devices that we have already CE Marked. What should I give him?

Class I devices are considered to be relatively Low Risk, and consequently do not need the approval of a Notified Body, (as do Class IIa, Class IIb and Class III, and incidentally so would Class I supplied Sterile or with a Measuring Function). They are Self Declared by the manufacturer himself with no third party involvement.

The conformance route then to affix the CE Mark for Class I devices is Self Certification via compliance with Annex VII.

So what documents should you give to your Customer?

1 - A copy of your Declaration of Conformity, which must refer to the particular products in question.

2 - The Certificate of Registration that your Authorized Representative provided you with. This Certificate is your confirmation from your Authorized Representative that your products were registered with one of the Competent Authorities in Europe. The Certificate will contain a reference # beginning with CA followed by 6 numerics, which your Authorized Representative was given by the Competent Authority, when he registered your devices..

3 - [1] and [2] above are the only documentation that you would normally receive.

4 - The only other document available would be the original letter that your Authorized Representative received from the Competent Authority, when he registered.

5 - Some Customers mistakenly believe that manufacturers of Class I devices must implement a Quality Management System (QMS), in order to comply with the MDD. But this is not the case. If you do not implement a QMS then you need to explain to your Customer that implementing a QMS is not mandatory for Class I devices.

If your Customer still requests further documents, you need to ask the specific nature of the documents and then seek help from your Authorized Representative.

 

 

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