CE self-certification for Class I device (face mask)

MedicalDevice

Involved In Discussions
#1
Hi everyone.
I hope you are well and healthy!
Could you please provide me with any information regarding what's needed to do a self-certification for a CE mark on a class I device (face mask)?
I have checked with our NB and was told that a self-assessment can be done by us for the face mask.

Also, is the self-certification applicable for a class I sterile medical device?
Appreciate all the help!
 
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shimonv

Trusted Information Resource
#2
Hi everyone.
I hope you are well and healthy!
Could you please provide me with any information regarding what's needed to do a self-certification for a CE mark on a class I device (face mask)?
I have checked with our NB and was told that a self-assessment can be done by us for the face mask.
Have a look at the following guidance on class I medical device:
Guidance on class 1 medical devices


Also, is the self-certification applicable for a class I sterile medical device?
Appreciate all the help!
Class I sterile devices has to be reviewed by a notified body.

Shimon
 

MedicalDevice

Involved In Discussions
#3
Thank you shimonv!
So, to my understanding, class I non-sterile can be self-certificated and the CE can be applied on these without the NB's identification number.
 

KShaw

Registered
#5
In essence you would need to build up your technical documentation and ensure you demonstrate compliance with the essential requirements in Annex I of the MDD. You should look into any standards which may be relevant to your device. Once compliant, you will be able to raise the Declaration of Conformity and place the CE mark on your devices.

Since this would be a class I medical device, you will also need to register the device in the EU Member State in which you are based prior to placing on the market. Should you be based outside of the EU, you must appoint an EU Authorised Representative who will carry out the device registration on your behalf.

Something else to keep in mind is the intended purpose of the device. If it is inteded to be worn by the healthcare professional in treating the patient and is intended to protect the patient, then it is a medical device. However, if this mask is intended to protect the wearer, you should look into meeting the EU PPE Regulation.

Hope this helps, good luck!
 

MedicalDevice

Involved In Discussions
#6
Since this would be a class I medical device, you will also need to register the device in the EU Member State in which you are based prior to placing on the market. Should you be based outside of the EU, you must appoint an EU Authorised Representative who will carry out the device registration on your behalf.
Do you maybe have more information regarding how to register the device in the EU Member State?
I am fairly new in this, so any help would be appreciated!
 

MedicalDevice

Involved In Discussions
#7
My last question on this topic is:
after having all the relevant documentation, declaration of conformity and registered the device in the EU member state, do I affix the CE myself (company) on the product? Or is there an authority/organization that does that?
 

twanmul

Involved In Discussions
#10
Do you maybe have more information regarding how to register the device in the EU Member State?
I am fairly new in this, so any help would be appreciated!
If you're in the UK, then the process for doing this is through the MHRA portal. You'll need to email the MHRA devices section to get an account. Any member state CA should allow you to do this, though my understanding is that you can use the Estonian database system using an Estonian e-passport if you have one (though this is what I've heard on the grapevine than through experience).

The regulatory flexibilities (if related to COVID-19 response) available at the moment could apply to your device though, so I'd recommend looking at these before you dive in fully.

You apply the CE mark yourself, though please ensure that the labels comply with the relevant harmonised standard(s).
 
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