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CE mark on a medical device - Textile product

#1
Hi,

Just discovered this forum and super glad that I did.
I'm laughing a new brand/shop with a product that I want to have a CE mark on (although it's not necessary but I want to do it to be registred with the medical devices authorities since it can be called a medical device; however it's just a textile product). It's a law risk medical device and I don't have to notify any bodies about it.

Question. I need to make sure I have all the documents/declarations and they are written as they should; how expensive it is to hire a consultant to help me with that?
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#2
Hello, and welcome to the Cove!

First, please be aware that you cannot choose for a product to be a medical device or not. If the intended use of the product falls under the scope of the regulation, it is a medical device. Surely, you as the manufacturer can "choose" to make some devices which are also non-medical devices a medical device by including a medical device-related intended use (which seem to be the case here).

Anyway, if the device is a Class I without measuring/sterilization, you do not need a "second" verification by a NB, so you need to verify confirm yourself and then put the CE Mark as required.

You can find several consultants that work with this and the price vary. My company does perform this kind of work, so if you with to discuss in more detail, you can reach me at marcelo@sqrconsulting.com.br.
 

Mikilk

Starting to get Involved
#3
In addition to Marcello - if your device falls under the scope of the EU medical device regulations, and you determined the classification as Class I (lowest class) you will need to make sure you fully comply with the regulations and that means that, among additional requirements, you will need to:

1) Establish a quality system that will be in compliance with the EU MDR - in the case of class I - not necessarily ISO 13585 and you don't need a notified body to approve it, but you need the appropriate procedures in place
2) you will need to cover the new Post Marketing Surveillance requirements in your system
3) if your company is not located in one of the EU countries you will need to contract EU authorized rep
4) you will need to establish a technical file that will be meeting the new regulations & Demonstrate that the Medical device meets the relevant general safety and performance requirements of Annex I of the medical devices Regulation 2017/745.
5) The European Authorised Representative if the manufacturer is located outside of EEA, must register with the Competent Authority

then you can CE mark your devices.
 
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